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 — OTHER
    Early 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) — OTHER
    Standard 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 bearing
    Full 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)

FacilityCityStateZIPSite coordinators
University of Utah OrthopedicsSalt Lake CityUtah84108-

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