Early Weight Bearing in Unicondylar Tibial Plateau Fractures

April 26, 2024 updated by: Justin Haller, University of Utah

Early Weight Bearing in Unicondylar Tibial Plateau Fractures: How Does it Affect Gait Pattern, Mobility and Overall Outcome: A Randomized Controlled Trial

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • University of Utah Orthopedics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average peak load (Newtons (N))
Time Frame: 6 weeks for early mobilization group
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))
Time Frame: 10 weeks for standard of care (SOC) group
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))
Time Frame: 1 week after full weight bearing is allowed for both 6 week early mobilization and SOC groups.
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))
Time Frame: 2 weeks after full weight bearing is allowed for both 6 week early mobilization and SOC groups.
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))
Time Frame: 6 weeks after full weight bearing is allowed for both 6 week early mobilization and SOC groups.
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))
Time Frame: 12 weeks after full weight bearing is allowed for both 6 week early mobilization and SOC groups.
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))
Time Frame: 6 months after full weight bearing is allowed for both 6 week early mobilization and SOC groups.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Investigators

  • Principal Investigator: Justin Haller, M.D., University of Utah Orthopaedics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2022

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

April 24, 2024

First Submitted That Met QC Criteria

April 26, 2024

First Posted (Actual)

April 29, 2024

Study Record Updates

Last Update Posted (Actual)

April 29, 2024

Last Update Submitted That Met QC Criteria

April 26, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 160848

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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