Early Weight Bearing in Unicondylar Tibial Plateau Fractures

NCT06389240 | Enrolling By Invitation DMC

• 1 other identifier: 160848
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Early Mobilization

Keywords

unicondylar tibia plateau fractures; early mobilization; Gait analysis

Outcome Measures

Primary Outcomes (7)

• Average peak load (Newtons (N))

  Gait analysis is performed while using force-measuring insoles. Patients are asked to complete an parcours with the force-measuring insoles (stand up from a chair with armrests, walk 10 meters, turn, walk back and sit down again. Afterwards (if possible), 5 steps with a handrail should be climbed up and down.

  6 weeks for early mobilization group

• Average peak load (Newtons (N))

  Gait analysis is performed while using force-measuring insoles. Patients are asked to complete an parcours with the force-measuring insoles (stand up from a chair with armrests, walk 10 meters, turn, walk back and sit down again. Afterwards (if possible), 5 steps with a handrail should be climbed up and down.

  10 weeks for standard of care (SOC) group

• Average peak load (Newtons (N))

  Gait analysis is performed while using force-measuring insoles. Patients are asked to complete an parcours with the force-measuring insoles (stand up from a chair with armrests, walk 10 meters, turn, walk back and sit down again. Afterwards (if possible), 5 steps with a handrail should be climbed up and down.

  1 week after full weight bearing is allowed for both 6 week early mobilization and SOC groups.

• Average peak load (Newtons (N))

  Gait analysis is performed while using force-measuring insoles. Patients are asked to complete an parcours with the force-measuring insoles (stand up from a chair with armrests, walk 10 meters, turn, walk back and sit down again. Afterwards (if possible), 5 steps with a handrail should be climbed up and down.

  2 weeks after full weight bearing is allowed for both 6 week early mobilization and SOC groups.

• Average peak load (Newtons (N))

  Gait analysis is performed while using force-measuring insoles. Patients are asked to complete an parcours with the force-measuring insoles (stand up from a chair with armrests, walk 10 meters, turn, walk back and sit down again. Afterwards (if possible), 5 steps with a handrail should be climbed up and down.

  6 weeks after full weight bearing is allowed for both 6 week early mobilization and SOC groups.

• Average peak load (Newtons (N))

  Gait analysis is performed while using force-measuring insoles. Patients are asked to complete an parcours with the force-measuring insoles (stand up from a chair with armrests, walk 10 meters, turn, walk back and sit down again. Afterwards (if possible), 5 steps with a handrail should be climbed up and down.

  12 weeks after full weight bearing is allowed for both 6 week early mobilization and SOC groups.

• Average peak load (Newtons (N))

  Gait analysis is performed while using force-measuring insoles. Patients are asked to complete an parcours with the force-measuring insoles (stand up from a chair with armrests, walk 10 meters, turn, walk back and sit down again. Afterwards (if possible), 5 steps with a handrail should be climbed up and down.

  6 months after full weight bearing is allowed for both 6 week early mobilization and SOC groups.

Study Arms (2)

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.

Other: 6 weeks post-operatively early weight bearing

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.

Other: 10 weeks post-operatively weight bearing (standard of care)

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).

6 weeks post-operatively early weight bearing

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).

10 weeks post-operatively weight bearing (standard of care)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients,18 - 65 years of age with a unilateral tibial plateau fracture.

You may qualify if:

• Adult patients, at least 18 years of age, max 65 years of age
• Unilateral tibial plateau fracture AO:41b/c
• Written consent to participate (consent can be revoked at any time without giving reasons)
• Surgery during the study period
• Follow-up on-site (Salt Lake City, Utah, United States)

You may not qualify if:

• Multiple injured or polytraumatized patients
• Other injuries or illnesses that impair the patient's mobility or gait
• Cognitive limitations such as dementia, delirium or similar disease
• Refusal to participate
• Severe underlying disease with significant limitations in the ability to regenerate e.g.
• malignancies
• Pathologic or osteoporotic fractures
• Unable to attend clinic in person for follow-ups
• pregnant women and fetus

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Orthopedics

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Justin Haller, M.D.

  University of Utah Orthopaedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: April 29, 2024
• Study Start: December 21, 2022
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

US (1)