Early Weight Bearing in Unicondylar Tibial Plateau Fractures

Early Mobilization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06389240
• Other study ID #: 160848
• Status: Active, not recruiting
• Start date: December 21, 2022
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Early Mobilization

Intervention

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)
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).

Locations

Country	Name	City	State
United States	University of Utah Orthopedics	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.