Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00284596
Status:
COMPLETED
Last Update Posted:
2009-01-29
First Post:
2006-01-31
Brief Title:
Fixation Stability and Bony Healing Following Open Wedge High Tibial Osteotomy
Sponsor:
Fowler Kennedy Sport Medicine Clinic
Organization:
Fowler Kennedy Sport Medicine Clinic
Study Overview
Official Title:
Fixation Stability and Progress of Bony Healing Following Open-Wedge High- Tibial Osteotomy A 24-Subject Clinical Pilot Study Using Radio Stereometric Analysis
Status:
COMPLETED
Status Verified Date:
2009-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients undergoing opening wedge high tibial osteotomy HTO will be randomized to standard or locking screw fixation of the osteotomy plate Tantalum beads will be implanted around the osteotomy site in all subjects to facilitate RSA imaging which will then allow micromotion at the osteotomy site to be quantified
Primary Objectives and Hypothesis
1 ato determine fixation stability of the Puddu opening wedge osteotomy plate secured with non-locking compared to locking screws We hypothesize that plate fixation with locking screws will result in a significant reduction of micromotion between tibial segments prior to bony healing compared to the non-locking screw fixation
bTo determine the progress of bony healing We hypothesize that increased fixation stability in patients with locking screws will facilitate early bone healing reflected by smaller micromotion over time compared to the non-locking screw patients
2 aIf there is improved stability with the use of locking screws rehabilitation protocols following opening wedge HTO will be modified accordingly We hypothesize that decreasing micromotion will reach the detection limit of the RSA setup 04 mm earlier in the locking screw group than in the non-locking screw group
bTo evaluate the effect of the osteotomy on proximal tibial anatomy We hypothesize that an open-wedge procedure might increase rather than decrease the tibial slope
Primary Objectives and Hypothesis
1 ato determine fixation stability of the Puddu opening wedge osteotomy plate secured with non-locking compared to locking screws We hypothesize that plate fixation with locking screws will result in a significant reduction of micromotion between tibial segments prior to bony healing compared to the non-locking screw fixation
bTo determine the progress of bony healing We hypothesize that increased fixation stability in patients with locking screws will facilitate early bone healing reflected by smaller micromotion over time compared to the non-locking screw patients
2 aIf there is improved stability with the use of locking screws rehabilitation protocols following opening wedge HTO will be modified accordingly We hypothesize that decreasing micromotion will reach the detection limit of the RSA setup 04 mm earlier in the locking screw group than in the non-locking screw group
bTo evaluate the effect of the osteotomy on proximal tibial anatomy We hypothesize that an open-wedge procedure might increase rather than decrease the tibial slope
Detailed Description:
For this pilot study a total of 24 patients scheduled for opening wedge HTO who meet the inclusion criteria have read the study letter of information and signed the informed consent will be randomized to osteotomy plate fixation with either non-locking screws 12 subjects or locking screws 12 subjects See flow chart 1
Pre-operative Assessment
All subjects will undergo routine pre-operative assessment for opening wedge high tibial osteotomy which includes
Documentation of demographic data and medical history
Subjective assessment of knee function using the Knee Injury and Osteoarthritis Outcome Score KOOS11
Standard physical evaluation of the lower limb assessing range of motion alignment knee-related signs and symptoms
Radiographs standing anteroposterior hip-to-ankle2 lateral view skyline patellar view at 30 of knee flexion bilateral weight-bearing posteroanterior PA tunnel view at 45 of knee flexion
Radiographic classification of arthrosis using the Kellgren scale4
Measurements of mechanical and anatomical axes of the lower limb and calculation of proposed correction angles
Surgery In the operating room all subjects will undergo the following steps
Induction of general anaesthesia
Percutaenous insertion into the proximal tibia surrounding the proposed osteotomy site under fluoroscopic guidance of 6 to 9 radio-opaque 08mm tantalum beads using a specifically designed gun A standardized pattern of widespread tantalum bead distribution will be used To avoid bead loosening caused by postoperative bone resorption they will be placed a distance of at least 05 cm from the osteotomy line
RSA imaging to evaluate bead position
Standard opening wedge HTO with the only variable being locking or non-locking screw fixation of the Puddu plate according to the randomization schedule This procedure is routinely carried out under fluoroscopic and or radiographic control
Second RSA imaging to obtain a reference film to assess stability
Standard wound closure and application of hinged brace
Postoperative Treatment All subjects will undergo the routine opening wedge HTO post-operative rehabilitation protocol
Follow-up Visits The times number and content of follow-up visits for study subjects will not differ from the standard post-operative visits scheduled for all patients who have undergone HTO However because RSA imaging is specialized this will be done at LHSC University Campus rather than at the Fowler Kennedy Sport Medicine Clinic FKSMC This will be communicated to patients in the letter of information Study follow-up visits are at 2 612 weeks and 6 months after surgery
At each study follow-up visit subjects will undergo
A subjective assessment of knee function using the KOOS
A standard physical evaluation of the lower limb assessing range of motion alignment knee-related signs and symptoms
Radiographs standing anteroposterior hip-to-ankle
RSA imaging in the AP and lateral planes simultaneously
Radiographs from each follow-up visit will be evaluated for classification of arthrosis using the Kellgren scale4 and for measurements of mechanical and anatomical axes of the lower limb and calculation of the correction angle obtained with HTO Translations between tibial segments will be calculated as previously described on the RSA images
Pre-operative Assessment
All subjects will undergo routine pre-operative assessment for opening wedge high tibial osteotomy which includes
Documentation of demographic data and medical history
Subjective assessment of knee function using the Knee Injury and Osteoarthritis Outcome Score KOOS11
Standard physical evaluation of the lower limb assessing range of motion alignment knee-related signs and symptoms
Radiographs standing anteroposterior hip-to-ankle2 lateral view skyline patellar view at 30 of knee flexion bilateral weight-bearing posteroanterior PA tunnel view at 45 of knee flexion
Radiographic classification of arthrosis using the Kellgren scale4
Measurements of mechanical and anatomical axes of the lower limb and calculation of proposed correction angles
Surgery In the operating room all subjects will undergo the following steps
Induction of general anaesthesia
Percutaenous insertion into the proximal tibia surrounding the proposed osteotomy site under fluoroscopic guidance of 6 to 9 radio-opaque 08mm tantalum beads using a specifically designed gun A standardized pattern of widespread tantalum bead distribution will be used To avoid bead loosening caused by postoperative bone resorption they will be placed a distance of at least 05 cm from the osteotomy line
RSA imaging to evaluate bead position
Standard opening wedge HTO with the only variable being locking or non-locking screw fixation of the Puddu plate according to the randomization schedule This procedure is routinely carried out under fluoroscopic and or radiographic control
Second RSA imaging to obtain a reference film to assess stability
Standard wound closure and application of hinged brace
Postoperative Treatment All subjects will undergo the routine opening wedge HTO post-operative rehabilitation protocol
Follow-up Visits The times number and content of follow-up visits for study subjects will not differ from the standard post-operative visits scheduled for all patients who have undergone HTO However because RSA imaging is specialized this will be done at LHSC University Campus rather than at the Fowler Kennedy Sport Medicine Clinic FKSMC This will be communicated to patients in the letter of information Study follow-up visits are at 2 612 weeks and 6 months after surgery
At each study follow-up visit subjects will undergo
A subjective assessment of knee function using the KOOS
A standard physical evaluation of the lower limb assessing range of motion alignment knee-related signs and symptoms
Radiographs standing anteroposterior hip-to-ankle
RSA imaging in the AP and lateral planes simultaneously
Radiographs from each follow-up visit will be evaluated for classification of arthrosis using the Kellgren scale4 and for measurements of mechanical and anatomical axes of the lower limb and calculation of the correction angle obtained with HTO Translations between tibial segments will be calculated as previously described on the RSA images
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