Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06636136
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Transtibial Osseointegration
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Transtibial Osseointegration Surgery Study TOSS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TOSS
Brief Summary:
Purpose
Aim 1 Quantify soft tissue complications and infections of service members with transtibial amputations treated with OPRA OI and compare them to transfemoral OI service members
Aim 2 Compare the validated domains such as functional quality of life and pain scores from the preoperative baseline to follow-up visits to determine if persons with transtibial amputations treated with OPRA osseointegrated prostheses demonstrate statistically significant and clinically relevant improvements
Aim 3 Compare physical performance measures preoperatively to follow-up visits for persons with transtibial amputations treated with OPRA osseointegrated prostheses to quantify statistically significant and clinically relevant improvements
Aim 4 Quantify the biomechanical loading and bone quality changes that are directly associated with patient reported outcomes for persons with transtibial amputations treated with OPRA osseointegration
Aim 5 Compare outcome measures between persons with traditional socket prostheses patients as self-controls and OPRA OI devices as well as a comparison between persons with transtibial OI and transfemoral OI
Subject Population
Male and female military health care beneficiaries age 22 to 65 years old presenting with a Transtibial limb loss
Study Design
This is a 4-year prospective cohort FDA pivotal study involving off-label use of the OPRA OI implant in persons with transtibial amputation
Procedures
SURGICAL PROCEDURES
Surgery Stage I
The distal part of the tibia is exposed preferably using existing incisions to produce an appropriate fasciocutaneous flap By the use of fluoroscopy and guiding devices the correct position of the fixture in the medullary canal is found The canal is reamed step by step to a proper diameter to facilitate insertion of the implant If the bone quality is poor as determined by the operating surgeon autologous bone graft from the iliac crest andor the medullary canal is used The fixture is then implanted into the intramedullary canal Careful surgical technique is essential not to damage the tissue and to achieve osseointegration A central screw healing cylinder and healing bolt are inserted A myodesis is performed and the wound is closed using suture
The sutures are removed 2-3 weeks postoperatively When the skin is completely healed the Patients conventional socket prosthesis could in some instances be used
Surgery Stage II 3-5 months after Stage I
The tibia is exposed via the incision from the Stage I-Surgery The healing cylinder is removed and the tissues are trimmed in a way that the distal end of the bone protrudes a few millimeters The skin will be attached directly to it The endosteal canal is reamed to facilitate placement of the abutment The skin in the abutment area is then trimmed to a diameter equal to the protruding end of the tibia This is done to remove the subcutaneous fat and facilitate healing of the dermal layer to the distal end of the bone The subcutaneous tissue is affixed to the periosteum using absorbable suture to prevent skin movement A 8mm punch biopsy tool is used to create a circular hole in the skin precisely over the residual tibial canal The remaining portion of the fasciocutaneous flap is sutured into position A bolster dressing is placed and routine postoperative wound care is performed by daily dressing changes Sutures are removed 2-3 weeks postoperatively
CLINICAL PROCEDURES
A pre-study visit will be conducted up to 6 months prior to Surgery Stage I Postoperative visits will occur 2-3 weeks after each surgery Additional follow-up visits will occur 6 12 24 36 48 and 60 months post-Surgery Stage II It is standard of care to follow patients postoperatively from time to time to ensure the wounds is are healing surveil for complications and ensure rehabilitation is progressing That said the sole reason for engaging in the Clinical Follow-Up Procedures is for the purpose of conducting research under this particular protocol Additional visits may occur including x-rays at the discretion of the clinical investigator in order to monitor the participants medical statusbone healing
RESEARCH PROCEDURES
Timepoints Baseline Post-Op Stage II 6 months 12 months 24 months 36 months 48 months and 60 months
The patients will be assessed before and after the surgery regularly Both performance and safety data will be recorded on specially designed electronic Case Report Forms eCRFs Clinical and radiological assessments are performed preoperatively in connection with the surgical procedures
Aim 1 Quantify soft tissue complications and infections of service members with transtibial amputations treated with OPRA OI and compare them to transfemoral OI service members
Aim 2 Compare the validated domains such as functional quality of life and pain scores from the preoperative baseline to follow-up visits to determine if persons with transtibial amputations treated with OPRA osseointegrated prostheses demonstrate statistically significant and clinically relevant improvements
Aim 3 Compare physical performance measures preoperatively to follow-up visits for persons with transtibial amputations treated with OPRA osseointegrated prostheses to quantify statistically significant and clinically relevant improvements
Aim 4 Quantify the biomechanical loading and bone quality changes that are directly associated with patient reported outcomes for persons with transtibial amputations treated with OPRA osseointegration
Aim 5 Compare outcome measures between persons with traditional socket prostheses patients as self-controls and OPRA OI devices as well as a comparison between persons with transtibial OI and transfemoral OI
Subject Population
Male and female military health care beneficiaries age 22 to 65 years old presenting with a Transtibial limb loss
Study Design
This is a 4-year prospective cohort FDA pivotal study involving off-label use of the OPRA OI implant in persons with transtibial amputation
Procedures
SURGICAL PROCEDURES
Surgery Stage I
The distal part of the tibia is exposed preferably using existing incisions to produce an appropriate fasciocutaneous flap By the use of fluoroscopy and guiding devices the correct position of the fixture in the medullary canal is found The canal is reamed step by step to a proper diameter to facilitate insertion of the implant If the bone quality is poor as determined by the operating surgeon autologous bone graft from the iliac crest andor the medullary canal is used The fixture is then implanted into the intramedullary canal Careful surgical technique is essential not to damage the tissue and to achieve osseointegration A central screw healing cylinder and healing bolt are inserted A myodesis is performed and the wound is closed using suture
The sutures are removed 2-3 weeks postoperatively When the skin is completely healed the Patients conventional socket prosthesis could in some instances be used
Surgery Stage II 3-5 months after Stage I
The tibia is exposed via the incision from the Stage I-Surgery The healing cylinder is removed and the tissues are trimmed in a way that the distal end of the bone protrudes a few millimeters The skin will be attached directly to it The endosteal canal is reamed to facilitate placement of the abutment The skin in the abutment area is then trimmed to a diameter equal to the protruding end of the tibia This is done to remove the subcutaneous fat and facilitate healing of the dermal layer to the distal end of the bone The subcutaneous tissue is affixed to the periosteum using absorbable suture to prevent skin movement A 8mm punch biopsy tool is used to create a circular hole in the skin precisely over the residual tibial canal The remaining portion of the fasciocutaneous flap is sutured into position A bolster dressing is placed and routine postoperative wound care is performed by daily dressing changes Sutures are removed 2-3 weeks postoperatively
CLINICAL PROCEDURES
A pre-study visit will be conducted up to 6 months prior to Surgery Stage I Postoperative visits will occur 2-3 weeks after each surgery Additional follow-up visits will occur 6 12 24 36 48 and 60 months post-Surgery Stage II It is standard of care to follow patients postoperatively from time to time to ensure the wounds is are healing surveil for complications and ensure rehabilitation is progressing That said the sole reason for engaging in the Clinical Follow-Up Procedures is for the purpose of conducting research under this particular protocol Additional visits may occur including x-rays at the discretion of the clinical investigator in order to monitor the participants medical statusbone healing
RESEARCH PROCEDURES
Timepoints Baseline Post-Op Stage II 6 months 12 months 24 months 36 months 48 months and 60 months
The patients will be assessed before and after the surgery regularly Both performance and safety data will be recorded on specially designed electronic Case Report Forms eCRFs Clinical and radiological assessments are performed preoperatively in connection with the surgical procedures
Detailed Description:
The patients will be regularly assessed during the follow-up period after the surgery Both performance and safety data will be recorded on specially designed electronic Case Report Forms eCRFs Clinical and radiological assessments are performed preoperatively in connection with the surgical procedures and at 6 12 24 36 48 and 60 months after completion of the surgical treatment
Prior to surgery the participant will have had their completed skeletal growth verified by radiographs andor CT scans
The participants will be asked to refrain from taking NSAID and salicylates for two weeks prior to and 6 weeks after surgery
Procedures will be performed by the study PI and AI Drs Potter and Anderson respectively Each has considerable experience in the treatment of combat related limb loss and the surgical procedures necessary to implant the OPRA device
SUMMARY OF THE SURGICAL PROCEDURES Surgery Stage I The distal part of the tibia is exposed preferably using existing amputation incisions to produce an appropriate fasciocutaneous flap Under fluoroscopic guidance the canal is reamed step by step to a proper diameter to facilitate insertion of the implant The fixture is then implanted into the intramedullary canal under fluoroscopic guidance Careful surgical technique is essential not to damage the tissue and to achieve osseointegration A central screw healing cylinder and healing bolt are inserted A myoplasty is performed and the wound is closed using sutures
Surgery Stage II 3-6 months after Stage I Through a limited incision the graft screw and components are removed Then cutaneous flaps are elevated and muscle is trimmed and then the muscle fascia is attached to the bone approximately 15cm proximal to the distal tibia using 0-vicryl A purse string stitch is then used to further reinforce the myoplasty The cutaneous flap is thinned and identified a suitable position for the skin penetration aperture on the superior flap A 8mm punch biopsy tool is used to create the aperture Using the abutment as a guide the fat layer is removed to expose the undersurface of the dermis A drain is placed exiting proximally on the lateral or medial side The flap is then rotated and fixed into position using a series of 2-0 Vicryl stutures The Abutment is then inserted and the threads were cleaned with an angiocatheter and saline flush The abutment screw is tightened by hand The anterior flap is then trimmed for closure and the incision is closed with 2-0 Monocryl 3-0 Monocryl and a self-adhering mesh with 2-octyl cyanoacrylate liquid adhesive Nitropaste is placed around the aperture and an antimicrobial foam dressing bolster This is held in place using the skate-board wheel donut provided for this purpose The patient remains on bedrest for 5 days to allow healing of the aperture site and skin flaps
CLININCAL PROCEDURES A pre-study visit will be conducted up to 6 months prior to Surgery Stage I Postoperative visits will occur 2-3 weeks after each surgery Additional follow-up visits will occur 6 12 24 36 48 and 60 months post-Surgery Stage II It is standard of care to follow patients postoperatively from time to time to ensure the wounds is are healing surveil for complications and ensure rehabilitation is progressing That said the sole reason for engaging in the Clinical Follow-Up Procedures is for the purpose of conducting research under this particular protocol Additional visits may occur including x-rays at the discretion of the clinical investigator in order to monitor the participants medical statusbone healing status
X-ray CT scan and function performance measure procedures are standard care RESEARCH PROCEDURES Timepoints Baseline Post-Op Stage II 6 months 12 months 24 months 36 months 48 months and 60 months
The participants will have up to 7 postoperative visits after each surgery
All questionnaires and DEXA are being administered performed for research purpose The DEXA scans will be performed at the Department of the Physical Medicine and Rehabilitation in the Biomechanics Lab at WRNMMC
Baseline Collection Patient Demographic characteristics amputation demographic characteristics Medication list Questionnaires Q-TFA OPUS functional status health quality of life index satisfaction of device and service and Clinical Survey PROMIS Physical Functions Pain Interference and Pain Behavior EQ-5D DVPRS Tampa Scale for Kinesiophobia TSK Functional Performance DEXA Physical MobilityTime Up and Go TUG Four Square Step Test 4SST 6-Minute Walk Test Amputee Mobility Predictor AMP Comprehensive High-Level Activity Mobility Predictor CHAMP Bilateral Amputee Mobility Predictor BAMP for bilateral amputee only 5 Time Sit to Stand 5TSTS and Metabolic Energy Expenditure and Radiography X-ray and CT Scan
Post-Op Stage II Surgery Questionnaires Q-TFA OPUS functional status health quality of life index and satisfaction of device and service PROMIS Physical Functions Pain Interference and Pain Behavior EQ-5D DVPRS Medication List and Tampa Scale for Kinesiophobia TSK and Radiography X-rays
6 Months Questionnaires Q-TFA OPUS functional status health quality of life index and satisfaction of device and service PROMIS Physical Functions Pain Interference and Pain Behavior EQ-5D DVPRS Medication List Tampa Scale for Kinesiophobia TSKand Radiography X-rays
12 Months Questionnaires Q-TFA OPUS functional status health quality of life index and satisfaction of device and service PROMIS Physical Functions Pain Interference and Pain Behavior EQ-5D DVPRS Medication List Tampa Scale for Kinesiophobia TSK Functional Performance DEXA Physical Mobility Time Up and Go TUG Four Square Step Test 4SST 6-Minute Walk Test Amputee Mobility Predictor AMP Comprehensive High-Level Activity Mobility Predictor CHAMP Bilateral Amputee Mobility PredictorBAMPfor bilateral amputees only 5 Time Sit to Stand 5TSTS and Metabolic Energy Expenditure and Radiography X-rays
24 Months Questionnaires Q-TFA OPUS functional status health quality of life index satisfaction of device and service and Clinical Survey PROMIS Physical Functions Pain Interference and Pain Behavior EQ-5D DVPRS Medication List Tampa Scale for Kinesiophobia TSK Functional Performance DEXA Physical Mobility Time Up and Go TUG Four Square Step Test 4SST 6-Minute Walk Test Amputee Mobility Predictor AMP Comprehensive High-Level Activity Mobility Predictor CHAMP Bilateral Amputee Mobility Predictor BAMPfor bilateral amputees only 5 Time Sit to Stand 5TSTS and Metabolic Energy Expenditure and Radiography X-rays
36 Months Questionnaires Q-TFA OPUS functional status health quality of life index satisfaction of device and service and Clinical Survey PROMIS Physical Functions Pain Interference and Pain Behavior EQ-5D DVPRS Medication List Tampa Scale for Kinesiophobia TSK Functional Performance DEXA Physical Mobility Time Up and Go TUG Four Square Step Test 4SST 6-Minute Walk Test Amputee Mobility Predictor AMP Comprehensive High-Level Activity Mobility Predictor CHAMP Bilateral Amputee Mobility Predictor BAMPfor bilateral amputees only 5 Time Sit to Stand 5TSTS and Metabolic Energy Expenditure and Radiography X-rays
48 Months Questionnaires Q-TFA OPUS functional status health quality of life index satisfaction of device and service and Clinical Survey PROMIS Physical Functions Pain Interference and Pain Behavior EQ-5D DVPRS Medication List Tampa Scale for Kinesiophobia TSK Functional Performance DEXA Physical Mobility Time Up and Go TUG Four Square Step Test 4SST 6-Minute Walk Test Amputee Mobility Predictor AMP Comprehensive High-Level Activity Mobility Predictor CHAMP Bilateral Amputee Mobility Predictor BAMPfor bilateral amputees only 5 Time Sit to Stand 5TSTS and Metabolic Energy Expenditure and Radiography X-rays
60 Months Questionnaires Q-TFA OPUS functional status health quality of life index satisfaction of device and service and Clinical Survey PROMIS Physical Functions Pain Interference and Pain Behavior EQ-5D DVPRS Medication List Tampa Scale for Kinesiophobia TSK and Decision Regret Functional Performance DEXA Physical Mobility Time Up and Go TUG Four Square Step Test 4SST 6-Minute Walk Test Amputee Mobility Predictor AMP Comprehensive High-Level Activity Mobility Predictor CHAMP Bilateral Amputee Mobility Predictor BAMPfor bilateral amputees only 5 Time Sit to Stand 5TSTS and Metabolic Energy Expenditure and Radiography X-rays
QUESTIONNAIRES Q-TFA Questionnaire for Persons with a Transfemoral Amputation A disease specific questionnaire evaluating functional and HRQL in limb loss population
OPUS-The Orthotic and Prosthetic Users Survey is a self-report questionnaire used for quality assessment to maintain awareness of improvement activities to evaluate changes in patients functional status and quality of life and assess satisfaction with devices and services functional status health quality of life index satisfaction of device and service and Clinical Survey
PROMIS Patient-Reported Outcomes Measurement Information System Physical Function Measures the outcome of patients with musculoskeletal disorders by assessing physical function through a grading scale of activities of daily living
Pain Interference Measures the extent to which pain hinders an individuals engagement with physical mental cognitive emotional recreational and social activities
Pain Behavior Measure self-reported external manifestations of pain EQ-5D a valid and reliable family of questionnaires to measure of health-related quality of life If the participants answers indicate they may be depressed they will be referred to behavioral health for further assessment
DVPRS a pain assessment tool that utilizes a numerical rating scale enhanced by functional word descriptors color coding and pictorial facial expressions matched to pain levels
Medication List Listing the medication the participant is taking Tampa Scale for Kinesiophobia TSK a 17-item questionnaire that quantifies fear of movement
Sane Score a single-question outcome measure that asks patients to rate their function as it pertains to the area being treated on a scale of 0 to 100
Decision Regret a question asking the participant if they would have the surgery again
FUNTIONAL PERFORMANCE Timed up and Go TUG a measure of physical mobility Four Square Step Test 4SST an objective reliable measure of dynamic balance that assesses the ability to step over objects forward sideways and backward
6-Minute Walk Test 6MWT an objective measure of mobility Amputee Mobility Predictor AMP provides a tool for measuring ambulation potential and can be administered either with or without prosthesis
Comprehensive High-Level Activity Mobility Predictor CHAMP a performance-based assessment used to measure higher level of functional mobility and consists of four advanced physical tests single-limb stance test Edgren side step test T-test and Illinois agility test
Bilateral Amputee Mobility Predictor BAMP the AMP for bilateral amputees biomechanical outcomes derived from gait evaluation
5 Time Sit to Stand 5TSTS a test used to assess instructed to stand up from sitting for five minutes as quickly as possible without using the hands for support
Metabolic Energy Expenditure Breath-by-breath oxygen consumption and heart rate will be measured continuously during a 5-10-minute rest followed by walking trails at multiple speeds with each of sufficient length to achieve steady-state
DEXA Whole body composition will be measured using linear fan beam dual energy x-ray absorptiometry Whole body composition scans will be performed on up to 4 localized sites 5 sites for those with bilateral TF limb loss spine L1-L4 bilateral Femur neck hip and Gruen zones around the osseointegrated implant
102 Data Collection Describe all the data variables information to be collected the source of the data and how the data will be operationally measured
A study team member will collect information on our source documentation from the study participant or through participants medical records at the following time points Baselinescreening 2-3 week post-operative from surgery stage II 6 months 12 months 24 months 36 months 48 months and 60 monthsfrom surgery stage II Data will be entered into REDCap
Baseline collected from the participant at initial screening Eligibility Checklist Patient Demographics Characteristics Amputation Demographic Characteristics Medication list Questionnaires Q-TFA OPUS Functional Status Quality of life of Life Index Satisfaction of Device and Services Clinical Survey PROMIS Physical Function Pain Interference Pain Behavior EQ-5D DVPRS Medication List Tampa Scale for Kinesiophobia TSK Clinical Assessment Physical Exam Pregnancy Test if applicable Functional Performance DEXA TUG 4SST 6-Minute Walk Test AMP CHAMP Bilateral Amputee Mobility Predictor 5TSTS Metabolic Energy Expenditure Radiography X-rays CT Post-Op Surgery Stage II Questionnaires Q-TFA OPUS Functional Status Quality of life of Life Index Satisfaction of Device and Services PROMIS Physical Function Pain Interference Pain Behavior EQ-5D DVPRS Medication List Tampa Scale for Kinesiophobia TSK Radiography X-rays Clinical Assessment Date of assessment skin penetration area assessment normal conditions redness secretion superficial infections deep infection infection history physical exam adverse event assessment
6 Months Follow Up Questionnaires Q-TFA OPUS Functional Status Quality of life of Life Index Satisfaction of Device and Services PROMIS Physical Function Pain Interference Pain Behavior EQ-5D DVPRS Medication List Tampa Scale for Kinesiophobia TSK Radiography X-rays Clinical Assessment Date of assessment skin penetration area assessment normal conditions redness secretion superficial infections deep infection infection history physical exam adverse event assessment
12 Months Follow Up Questionnaires Q-TFA OPUS Functional Status Quality of life of Life Index Satisfaction of Device and Services Clinical Survey PROMIS Physical Function Pain Interference Pain Behavior EQ-5D DVPRS Medication List Tampa Scale for Kinesiophobia TSK Functional Performance DEXA TUG 4SST 6-Minute Walk Test AMP CHAMP Bilateral Amputee Mobility Predictor 5TSTS Metabolic Energy Expenditure Radiography X-rays Clinical Assessment Date of assessment skin penetration area assessment normal conditions redness secretion superficial infections deep infection infection history physical exam adverse event assessment
24 Months Follow Up Questionnaires Q-TFA OPUS Functional Status Quality of life of Life Index Satisfaction of Device and Services Clinical Survey PROMIS Physical Function Pain Interference Pain Behavior EQ-5D DVPRS Medication List Tampa Scale for Kinesiophobia TSK Functional Performance DEXA TUG 4SST 6-Minute Walk Test AMP CHAMP Bilateral Amputee Mobility Predictor 5TSTS Metabolic Energy Expenditure Radiography X-rays Clinical Assessment Date of assessment skin penetration area assessment normal conditions redness secretion superficial infections deep infection infection history physical exam adverse event assessment
36 Months Follow Up Questionnaires Q-TFA OPUS Functional Status Quality of life of Life Index Satisfaction of Device and Services Clinical Survey PROMIS Physical Function Pain Interference Pain Behavior EQ-5D DVPRS Medication List Tampa Scale for Kinesiophobia TSK Functional Performance DEXA TUG 4SST 6-Minute Walk Test AMP CHAMP Bilateral Amputee Mobility Predictor 5TSTS Metabolic Energy Expenditure Radiography X-rays Clinical Assessment Date of assessment skin penetration area assessment normal conditions redness secretion superficial infections deep infection infection history physical exam adverse event assessment
48 Months Follow Up Questionnaires Q-TFA OPUS Functional Status Quality of life of Life Index Satisfaction of Device and Services Clinical Survey PROMIS Physical Function Pain Interference Pain Behavior EQ-5D DVPRS Medication List Tampa Scale for Kinesiophobia TSK Functional Performance DEXA TUG 4SST 6-Minute Walk Test AMP CHAMP Bilateral Amputee Mobility Predictor 5TSTS Metabolic Energy Expenditure Radiography X-rays Clinical Assessment Date of assessment skin penetration area assessment normal conditions redness secretion superficial infections deep infection infection history physical exam adverse event assessment
60 Months Follow Up Questionnaires Q-TFA OPUS Functional Status Quality of life of Life Index Satisfaction of Device and Services Clinical Survey PROMIS Physical Function Pain Interference Pain Behavior EQ-5D DVPRS Medication List Tampa Scale for Kinesiophobia TSK Decision Regret Functional Performance DEXA TUG 4SST 6-Minute Walk Test AMP CHAMP Bilateral Amputee Mobility Predictor 5TSTS Metabolic Energy Expenditure Radiography X-rays Clinical Assessment Date of assessment skin penetration area assessment normal conditions redness secretion superficial infections deep infection infection history physical exam adverse event assessment
For bilateral amputees only
For clinical purposes
Prior to surgery the participant will have had their completed skeletal growth verified by radiographs andor CT scans
The participants will be asked to refrain from taking NSAID and salicylates for two weeks prior to and 6 weeks after surgery
Procedures will be performed by the study PI and AI Drs Potter and Anderson respectively Each has considerable experience in the treatment of combat related limb loss and the surgical procedures necessary to implant the OPRA device
SUMMARY OF THE SURGICAL PROCEDURES Surgery Stage I The distal part of the tibia is exposed preferably using existing amputation incisions to produce an appropriate fasciocutaneous flap Under fluoroscopic guidance the canal is reamed step by step to a proper diameter to facilitate insertion of the implant The fixture is then implanted into the intramedullary canal under fluoroscopic guidance Careful surgical technique is essential not to damage the tissue and to achieve osseointegration A central screw healing cylinder and healing bolt are inserted A myoplasty is performed and the wound is closed using sutures
Surgery Stage II 3-6 months after Stage I Through a limited incision the graft screw and components are removed Then cutaneous flaps are elevated and muscle is trimmed and then the muscle fascia is attached to the bone approximately 15cm proximal to the distal tibia using 0-vicryl A purse string stitch is then used to further reinforce the myoplasty The cutaneous flap is thinned and identified a suitable position for the skin penetration aperture on the superior flap A 8mm punch biopsy tool is used to create the aperture Using the abutment as a guide the fat layer is removed to expose the undersurface of the dermis A drain is placed exiting proximally on the lateral or medial side The flap is then rotated and fixed into position using a series of 2-0 Vicryl stutures The Abutment is then inserted and the threads were cleaned with an angiocatheter and saline flush The abutment screw is tightened by hand The anterior flap is then trimmed for closure and the incision is closed with 2-0 Monocryl 3-0 Monocryl and a self-adhering mesh with 2-octyl cyanoacrylate liquid adhesive Nitropaste is placed around the aperture and an antimicrobial foam dressing bolster This is held in place using the skate-board wheel donut provided for this purpose The patient remains on bedrest for 5 days to allow healing of the aperture site and skin flaps
CLININCAL PROCEDURES A pre-study visit will be conducted up to 6 months prior to Surgery Stage I Postoperative visits will occur 2-3 weeks after each surgery Additional follow-up visits will occur 6 12 24 36 48 and 60 months post-Surgery Stage II It is standard of care to follow patients postoperatively from time to time to ensure the wounds is are healing surveil for complications and ensure rehabilitation is progressing That said the sole reason for engaging in the Clinical Follow-Up Procedures is for the purpose of conducting research under this particular protocol Additional visits may occur including x-rays at the discretion of the clinical investigator in order to monitor the participants medical statusbone healing status
X-ray CT scan and function performance measure procedures are standard care RESEARCH PROCEDURES Timepoints Baseline Post-Op Stage II 6 months 12 months 24 months 36 months 48 months and 60 months
The participants will have up to 7 postoperative visits after each surgery
All questionnaires and DEXA are being administered performed for research purpose The DEXA scans will be performed at the Department of the Physical Medicine and Rehabilitation in the Biomechanics Lab at WRNMMC
Baseline Collection Patient Demographic characteristics amputation demographic characteristics Medication list Questionnaires Q-TFA OPUS functional status health quality of life index satisfaction of device and service and Clinical Survey PROMIS Physical Functions Pain Interference and Pain Behavior EQ-5D DVPRS Tampa Scale for Kinesiophobia TSK Functional Performance DEXA Physical MobilityTime Up and Go TUG Four Square Step Test 4SST 6-Minute Walk Test Amputee Mobility Predictor AMP Comprehensive High-Level Activity Mobility Predictor CHAMP Bilateral Amputee Mobility Predictor BAMP for bilateral amputee only 5 Time Sit to Stand 5TSTS and Metabolic Energy Expenditure and Radiography X-ray and CT Scan
Post-Op Stage II Surgery Questionnaires Q-TFA OPUS functional status health quality of life index and satisfaction of device and service PROMIS Physical Functions Pain Interference and Pain Behavior EQ-5D DVPRS Medication List and Tampa Scale for Kinesiophobia TSK and Radiography X-rays
6 Months Questionnaires Q-TFA OPUS functional status health quality of life index and satisfaction of device and service PROMIS Physical Functions Pain Interference and Pain Behavior EQ-5D DVPRS Medication List Tampa Scale for Kinesiophobia TSKand Radiography X-rays
12 Months Questionnaires Q-TFA OPUS functional status health quality of life index and satisfaction of device and service PROMIS Physical Functions Pain Interference and Pain Behavior EQ-5D DVPRS Medication List Tampa Scale for Kinesiophobia TSK Functional Performance DEXA Physical Mobility Time Up and Go TUG Four Square Step Test 4SST 6-Minute Walk Test Amputee Mobility Predictor AMP Comprehensive High-Level Activity Mobility Predictor CHAMP Bilateral Amputee Mobility PredictorBAMPfor bilateral amputees only 5 Time Sit to Stand 5TSTS and Metabolic Energy Expenditure and Radiography X-rays
24 Months Questionnaires Q-TFA OPUS functional status health quality of life index satisfaction of device and service and Clinical Survey PROMIS Physical Functions Pain Interference and Pain Behavior EQ-5D DVPRS Medication List Tampa Scale for Kinesiophobia TSK Functional Performance DEXA Physical Mobility Time Up and Go TUG Four Square Step Test 4SST 6-Minute Walk Test Amputee Mobility Predictor AMP Comprehensive High-Level Activity Mobility Predictor CHAMP Bilateral Amputee Mobility Predictor BAMPfor bilateral amputees only 5 Time Sit to Stand 5TSTS and Metabolic Energy Expenditure and Radiography X-rays
36 Months Questionnaires Q-TFA OPUS functional status health quality of life index satisfaction of device and service and Clinical Survey PROMIS Physical Functions Pain Interference and Pain Behavior EQ-5D DVPRS Medication List Tampa Scale for Kinesiophobia TSK Functional Performance DEXA Physical Mobility Time Up and Go TUG Four Square Step Test 4SST 6-Minute Walk Test Amputee Mobility Predictor AMP Comprehensive High-Level Activity Mobility Predictor CHAMP Bilateral Amputee Mobility Predictor BAMPfor bilateral amputees only 5 Time Sit to Stand 5TSTS and Metabolic Energy Expenditure and Radiography X-rays
48 Months Questionnaires Q-TFA OPUS functional status health quality of life index satisfaction of device and service and Clinical Survey PROMIS Physical Functions Pain Interference and Pain Behavior EQ-5D DVPRS Medication List Tampa Scale for Kinesiophobia TSK Functional Performance DEXA Physical Mobility Time Up and Go TUG Four Square Step Test 4SST 6-Minute Walk Test Amputee Mobility Predictor AMP Comprehensive High-Level Activity Mobility Predictor CHAMP Bilateral Amputee Mobility Predictor BAMPfor bilateral amputees only 5 Time Sit to Stand 5TSTS and Metabolic Energy Expenditure and Radiography X-rays
60 Months Questionnaires Q-TFA OPUS functional status health quality of life index satisfaction of device and service and Clinical Survey PROMIS Physical Functions Pain Interference and Pain Behavior EQ-5D DVPRS Medication List Tampa Scale for Kinesiophobia TSK and Decision Regret Functional Performance DEXA Physical Mobility Time Up and Go TUG Four Square Step Test 4SST 6-Minute Walk Test Amputee Mobility Predictor AMP Comprehensive High-Level Activity Mobility Predictor CHAMP Bilateral Amputee Mobility Predictor BAMPfor bilateral amputees only 5 Time Sit to Stand 5TSTS and Metabolic Energy Expenditure and Radiography X-rays
QUESTIONNAIRES Q-TFA Questionnaire for Persons with a Transfemoral Amputation A disease specific questionnaire evaluating functional and HRQL in limb loss population
OPUS-The Orthotic and Prosthetic Users Survey is a self-report questionnaire used for quality assessment to maintain awareness of improvement activities to evaluate changes in patients functional status and quality of life and assess satisfaction with devices and services functional status health quality of life index satisfaction of device and service and Clinical Survey
PROMIS Patient-Reported Outcomes Measurement Information System Physical Function Measures the outcome of patients with musculoskeletal disorders by assessing physical function through a grading scale of activities of daily living
Pain Interference Measures the extent to which pain hinders an individuals engagement with physical mental cognitive emotional recreational and social activities
Pain Behavior Measure self-reported external manifestations of pain EQ-5D a valid and reliable family of questionnaires to measure of health-related quality of life If the participants answers indicate they may be depressed they will be referred to behavioral health for further assessment
DVPRS a pain assessment tool that utilizes a numerical rating scale enhanced by functional word descriptors color coding and pictorial facial expressions matched to pain levels
Medication List Listing the medication the participant is taking Tampa Scale for Kinesiophobia TSK a 17-item questionnaire that quantifies fear of movement
Sane Score a single-question outcome measure that asks patients to rate their function as it pertains to the area being treated on a scale of 0 to 100
Decision Regret a question asking the participant if they would have the surgery again
FUNTIONAL PERFORMANCE Timed up and Go TUG a measure of physical mobility Four Square Step Test 4SST an objective reliable measure of dynamic balance that assesses the ability to step over objects forward sideways and backward
6-Minute Walk Test 6MWT an objective measure of mobility Amputee Mobility Predictor AMP provides a tool for measuring ambulation potential and can be administered either with or without prosthesis
Comprehensive High-Level Activity Mobility Predictor CHAMP a performance-based assessment used to measure higher level of functional mobility and consists of four advanced physical tests single-limb stance test Edgren side step test T-test and Illinois agility test
Bilateral Amputee Mobility Predictor BAMP the AMP for bilateral amputees biomechanical outcomes derived from gait evaluation
5 Time Sit to Stand 5TSTS a test used to assess instructed to stand up from sitting for five minutes as quickly as possible without using the hands for support
Metabolic Energy Expenditure Breath-by-breath oxygen consumption and heart rate will be measured continuously during a 5-10-minute rest followed by walking trails at multiple speeds with each of sufficient length to achieve steady-state
DEXA Whole body composition will be measured using linear fan beam dual energy x-ray absorptiometry Whole body composition scans will be performed on up to 4 localized sites 5 sites for those with bilateral TF limb loss spine L1-L4 bilateral Femur neck hip and Gruen zones around the osseointegrated implant
102 Data Collection Describe all the data variables information to be collected the source of the data and how the data will be operationally measured
A study team member will collect information on our source documentation from the study participant or through participants medical records at the following time points Baselinescreening 2-3 week post-operative from surgery stage II 6 months 12 months 24 months 36 months 48 months and 60 monthsfrom surgery stage II Data will be entered into REDCap
Baseline collected from the participant at initial screening Eligibility Checklist Patient Demographics Characteristics Amputation Demographic Characteristics Medication list Questionnaires Q-TFA OPUS Functional Status Quality of life of Life Index Satisfaction of Device and Services Clinical Survey PROMIS Physical Function Pain Interference Pain Behavior EQ-5D DVPRS Medication List Tampa Scale for Kinesiophobia TSK Clinical Assessment Physical Exam Pregnancy Test if applicable Functional Performance DEXA TUG 4SST 6-Minute Walk Test AMP CHAMP Bilateral Amputee Mobility Predictor 5TSTS Metabolic Energy Expenditure Radiography X-rays CT Post-Op Surgery Stage II Questionnaires Q-TFA OPUS Functional Status Quality of life of Life Index Satisfaction of Device and Services PROMIS Physical Function Pain Interference Pain Behavior EQ-5D DVPRS Medication List Tampa Scale for Kinesiophobia TSK Radiography X-rays Clinical Assessment Date of assessment skin penetration area assessment normal conditions redness secretion superficial infections deep infection infection history physical exam adverse event assessment
6 Months Follow Up Questionnaires Q-TFA OPUS Functional Status Quality of life of Life Index Satisfaction of Device and Services PROMIS Physical Function Pain Interference Pain Behavior EQ-5D DVPRS Medication List Tampa Scale for Kinesiophobia TSK Radiography X-rays Clinical Assessment Date of assessment skin penetration area assessment normal conditions redness secretion superficial infections deep infection infection history physical exam adverse event assessment
12 Months Follow Up Questionnaires Q-TFA OPUS Functional Status Quality of life of Life Index Satisfaction of Device and Services Clinical Survey PROMIS Physical Function Pain Interference Pain Behavior EQ-5D DVPRS Medication List Tampa Scale for Kinesiophobia TSK Functional Performance DEXA TUG 4SST 6-Minute Walk Test AMP CHAMP Bilateral Amputee Mobility Predictor 5TSTS Metabolic Energy Expenditure Radiography X-rays Clinical Assessment Date of assessment skin penetration area assessment normal conditions redness secretion superficial infections deep infection infection history physical exam adverse event assessment
24 Months Follow Up Questionnaires Q-TFA OPUS Functional Status Quality of life of Life Index Satisfaction of Device and Services Clinical Survey PROMIS Physical Function Pain Interference Pain Behavior EQ-5D DVPRS Medication List Tampa Scale for Kinesiophobia TSK Functional Performance DEXA TUG 4SST 6-Minute Walk Test AMP CHAMP Bilateral Amputee Mobility Predictor 5TSTS Metabolic Energy Expenditure Radiography X-rays Clinical Assessment Date of assessment skin penetration area assessment normal conditions redness secretion superficial infections deep infection infection history physical exam adverse event assessment
36 Months Follow Up Questionnaires Q-TFA OPUS Functional Status Quality of life of Life Index Satisfaction of Device and Services Clinical Survey PROMIS Physical Function Pain Interference Pain Behavior EQ-5D DVPRS Medication List Tampa Scale for Kinesiophobia TSK Functional Performance DEXA TUG 4SST 6-Minute Walk Test AMP CHAMP Bilateral Amputee Mobility Predictor 5TSTS Metabolic Energy Expenditure Radiography X-rays Clinical Assessment Date of assessment skin penetration area assessment normal conditions redness secretion superficial infections deep infection infection history physical exam adverse event assessment
48 Months Follow Up Questionnaires Q-TFA OPUS Functional Status Quality of life of Life Index Satisfaction of Device and Services Clinical Survey PROMIS Physical Function Pain Interference Pain Behavior EQ-5D DVPRS Medication List Tampa Scale for Kinesiophobia TSK Functional Performance DEXA TUG 4SST 6-Minute Walk Test AMP CHAMP Bilateral Amputee Mobility Predictor 5TSTS Metabolic Energy Expenditure Radiography X-rays Clinical Assessment Date of assessment skin penetration area assessment normal conditions redness secretion superficial infections deep infection infection history physical exam adverse event assessment
60 Months Follow Up Questionnaires Q-TFA OPUS Functional Status Quality of life of Life Index Satisfaction of Device and Services Clinical Survey PROMIS Physical Function Pain Interference Pain Behavior EQ-5D DVPRS Medication List Tampa Scale for Kinesiophobia TSK Decision Regret Functional Performance DEXA TUG 4SST 6-Minute Walk Test AMP CHAMP Bilateral Amputee Mobility Predictor 5TSTS Metabolic Energy Expenditure Radiography X-rays Clinical Assessment Date of assessment skin penetration area assessment normal conditions redness secretion superficial infections deep infection infection history physical exam adverse event assessment
For bilateral amputees only
For clinical purposes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None