Ignite Creation Date:
2024-05-06 @ 2:39 PM
Last Modification Date:
2024-10-26 @ 1:35 PM
Study NCT ID:
NCT04389749
Status:
RECRUITING
Last Update Posted:
2023-11-28
First Post:
2020-04-26
Brief Title:
Continuous Passive Motion Following Fixation of Pelvic and Knee Fractures
Sponsor:
University of Cincinnati
Organization:
University of Cincinnati
Study Overview
Official Title:
The Role of Continuous Passive Motion in Pain Control of Patients Undergoing Operative Management of Isolated Acetabular Fractures Supracondylar Femur Fractures or Tibial Plateau Fracture A Comparative Study
Status:
RECRUITING
Status Verified Date:
2023-11
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:
The investigators will directly compare the visual analog scale scores and narcotic pain medication requirements in the patients who have continuous passive motion CPM versus those who do not during the course of the hospital admission following an open reduction internal fixation surgery for acetabular fracture supracondylar femur fracture or a tibial plateau fracture
Detailed Description:
This will be a prospective comparative cohort study analyzing the practices of three surgeons one of whom routinely uses CPM following fixation of pelvic and acetabular fractures and two surgeons who do not
All patients over the age of 18 years who have undergone open reduction and internal fixation ORIF of isolated acetabular fractures supracondylar femur fractures or tibial plateau fracture will be asked to participate Those who consent will be randomized into two groups The experimental group will have a CPM applied in the PACU immediately post-op and it will be utilized while the patient is awake in bed for 2 hours on and 2 hours off when not mobilizing with Physical Therapy PT The experimental group will also have traditional PT including sessions 1 to 3 times a week The control group will have typical care including working with physical therapy 1 to 3 times a week The investigators will directly compare the VAS scores and narcotic pain medication requirements in the patients who have CPM versus those who do not during the course of the hospital admission VAS scores will be assessed throughout the day by RN andor PT Functional outcomes will be assessed at the one-year mark using the Iowa and Majeed pelvic functional outcome tools along with the SF-12 Orthopedic Resident or Nurse Clinical will check the patient for incision integrity each day and each session of using the CPM the patient will be monitored for adverse events Data will be collected using Epic
The investigators will record patient demographics including age sex and pre-existing narcotic usage Fracture type according to the Orthopaedic Trauma Association will be recorded VAS scores and pain medication requirements will be recorded from the first 48 hours during the patients stay Pain scores and CPM use will be obtained from Epic using the flowsheet
Functional outcomes will be assessed at the one-year mark using the Iowa and Majeed pelvic functional outcome tools along with the SF-12
All patients over the age of 18 years who have undergone open reduction and internal fixation ORIF of isolated acetabular fractures supracondylar femur fractures or tibial plateau fracture will be asked to participate Those who consent will be randomized into two groups The experimental group will have a CPM applied in the PACU immediately post-op and it will be utilized while the patient is awake in bed for 2 hours on and 2 hours off when not mobilizing with Physical Therapy PT The experimental group will also have traditional PT including sessions 1 to 3 times a week The control group will have typical care including working with physical therapy 1 to 3 times a week The investigators will directly compare the VAS scores and narcotic pain medication requirements in the patients who have CPM versus those who do not during the course of the hospital admission VAS scores will be assessed throughout the day by RN andor PT Functional outcomes will be assessed at the one-year mark using the Iowa and Majeed pelvic functional outcome tools along with the SF-12 Orthopedic Resident or Nurse Clinical will check the patient for incision integrity each day and each session of using the CPM the patient will be monitored for adverse events Data will be collected using Epic
The investigators will record patient demographics including age sex and pre-existing narcotic usage Fracture type according to the Orthopaedic Trauma Association will be recorded VAS scores and pain medication requirements will be recorded from the first 48 hours during the patients stay Pain scores and CPM use will be obtained from Epic using the flowsheet
Functional outcomes will be assessed at the one-year mark using the Iowa and Majeed pelvic functional outcome tools along with the SF-12
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None