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Enrolling by Invitation

NCT Number: NCT06389240

Early Weight Bearing in Unicondylar Tibial Plateau Fractures

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

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Key information

Conditions

Early Mobilization

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Utah Orthopedics

Salt Lake City, Utah, 84108, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Apr 29, 2024
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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