Early Weight Bearing in Unicondylar Tibial Plateau Fractures
Part of paid clinical trials in Salt Lake City, Utah.
- Sponsor
- University of Utah
- Study ID
- NCT06389240
- Status
- Enrolling By Invitation
Conditions
- Early Mobilization
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- 6 weeks post-operatively early weight bearing — OTHEREarly mobilization 6 weeks post-operatively. Gait analyses is carried out on when full mobilization is allowed. Gait analysis is performed while using force-measuring insoles (loadsol, Novel).
- 10 weeks post-operatively weight bearing (standard of care) — OTHERStandard of care mobilization at 10 weeks post-operatively. Gait analyses is carried out on when full mobilization is allowed. Gait analysis is performed while using force-measuring insoles (loadsol, Novel).
Study Details
The investigators aim of the study is to assess the effects of early mobilization after surgically treated unicondylar tibia plateau fractures (6 weeks without weight bearing) on gait, patient satisfaction, return to work/sports and complication rate. The data will be compared to a 10-12 week non-weight bearing group (standard of care). It is assumed that earlier mobilization does not lead to an increase in the complications - in particular osteosynthesis failure and infections -, but leads to improved patient satisfaction, reduced return to work/sports times, and has a positive impact on the overall outcome
Key Dates
- Start date
- Dec 21, 2022
- Status verified
- Apr 2026
- Primary completion
- Dec 31, 2028
- Completion
- Dec 31, 2028
Study Design
- Enrollment
- 60 participants (estimated)
Arms
- Arm: 6 weeks post-operatively early weight bearingFull weight bearing will be allowed 6 weeks post-operatively. Gait analyses is carried out on when full weight-bearing is allowed.
- Arm: 10 weeks post-operatively weight bearing (standard of care)Full weight bearing will be allowed 10 weeks post-operatively. Gait analyses is carried out on when full weight-bearing is allowed.
Primary Outcome Measure
Average peak load (Newtons (N)) [ Time Frame: 6 weeks for early mobilization group ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Utah Orthopedics | Salt Lake City | Utah | 84108 | - |