Clinical trial NCT06389240: Early Weight Bearing in Unicondylar Tibial Plateau Fractures
Official title: Early Weight Bearing in Unicondylar Tibial Plateau Fractures: How Does It Affect Gait Pattern, Mobility and Overall Outcome: a Randomized Controlled Trial
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Early Mobilization
Keywords: unicondylar tibia plateau fractures
early mobilization
Gait analysis
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients,18 - 65 years of age with a unilateral tibial plateau fracture.

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.

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

Primary outcomes:
measure: Average peak load (Newtons (N))
timeFrame: 6 weeks for early mobilization group
measure: Average peak load (Newtons (N))
timeFrame: 10 weeks for standard of care (SOC) group
measure: Average peak load (Newtons (N))
timeFrame: 1 week after full weight bearing is allowed for both 6 week early mobilization and SOC groups.
measure: Average peak load (Newtons (N))
timeFrame: 2 weeks after full weight bearing is allowed for both 6 week early mobilization and SOC groups.
measure: Average peak load (Newtons (N))
timeFrame: 6 weeks after full weight bearing is allowed for both 6 week early mobilization and SOC groups.
measure: Average peak load (Newtons (N))
timeFrame: 12 weeks after full weight bearing is allowed for both 6 week early mobilization and SOC groups.
measure: Average peak load (Newtons (N))
timeFrame: 6 months after full weight bearing is allowed for both 6 week early mobilization and SOC groups.
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Orthopedics
state: Utah
Study officials:
affiliation: University of Utah Orthopaedics
name: Justin Haller, M.D.
role: PRINCIPAL_INVESTIGATOR
References: