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Enrolling by invitation NCT06389240

Early Weight Bearing in Unicondylar Tibial Plateau Fractures

— Observational Early Mobilization

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 6 weeks post-operatively early weight bearing, 10 weeks post-operatively weight bearing (standard of care).
Who it may be relevant to
Registry conditions: Early Mobilization. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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).
  • 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).

Primary outcome measures

  • Average peak load (Newtons (N)) [Time frame: 6 weeks for early mobilization group]
  • Average peak load (Newtons (N)) [Time frame: 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.]
  • Average peak load (Newtons (N)) [Time frame: 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.]
  • Average peak load (Newtons (N)) [Time frame: 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.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • University of Utah Orthopedics — Salt Lake City

Identifiers

NCT: NCT06389240 · 160848

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗