Early Weight Bearing in Unicondylar Tibial Plateau Fractures

NCT ID: NCT06389240

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-21
• Study Completion Date: 2026-12-31

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

Detailed Description

Tibial plateau fractures are common sports injuries caused by accidents such as skiing and mountain biking. Thus, young adults with high functional and athletic demands are often affected. The best possible restoration of the original joint function and resilience is therefore particularly important for this group of patients. In addition, prolonged immobilization in this patient group poses a high risk of loss of earnings and a significant impairment in athletic performance.

These injuries usually require surgical treatment which is followed by 10-12 weeks without weight bearing. In recent years, there has been a shift towards earlier mobilization with many injuries. In addition, numerous studies showed the negative effects of prolonged immobility. Nevertheless, these negative effects must always be weighed against the possibility of osteosynthesis failure.

Conditions

Early Mobilization

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

6 weeks post-operatively early weight bearing

Intervention Type: 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)

Full weight bearing will be allowed 10 weeks post-operatively. Gait analyses is carried out on when full weight-bearing is allowed.

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

Intervention Type: 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).

Interventions

6 weeks post-operatively early weight bearing

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).

Intervention Type: OTHER

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

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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Justin Haller

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Justin Haller, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Utah Orthopaedics

Locations

University of Utah Orthopedics

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

160848

Identifier Type: -

Identifier Source: org_study_id