Continuous Passive Motion Following Fixation of Pelvic and Knee Fractures
Part of paid clinical trials in Cincinnati, Ohio.
- Sponsor
- University of Cincinnati
- Study ID
- NCT04389749
- Status
- Recruiting
Conditions
- Fractures, Bone
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- CPM — DEVICECPM-continuous passive motion device.
Study Details
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.
Key Dates
- Start date
- Oct 6, 2020
- Status verified
- Apr 2026
- Primary completion
- Jun 30, 2026
- Completion
- Jun 30, 2027
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- OTHER
Arms
- Experimental: CPMThe 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.
- No Intervention: No CPMThe control group will have typical care, including working with physical therapy 1 to 3 times a week.
Primary Outcome Measure
VAS Pain Score [ Time Frame: Visual Analog Score for pain will be recorded daily after the surgery each day until the patient is discharged or up to 365 days.. ]
Central Contacts
- Kimberly A Hasselfeld, MS513-558-1933
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Univrsity of Cincinnati Medical Center | Cincinnati | Ohio | 45267 | Henry Sagi, MD 5137776213 |
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