Comparing weight-bearing methods after tibial shaft fractures

Limb Injuries and Post Injury Rehabilitation Trials - Tibial Shaft Fracture (LIMPER-TSF): a Protocol for Prospective, Randomized,Multicentre Trial Comparing the Early Partial and Early Full Weightbearing After Nailed Tibial Shaft Fracture

This study is testing whether putting full weight on a leg right away or only part of the weight for six weeks helps adults recover better after surgery for a specific type of leg fracture.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Tampere University Hospital (other)
• Locations: 3 sites (Jyväskylä, Central Finland and 2 other locations)
• Trial ID: NCT05151926 on ClinicalTrials.gov

What this trial studies

This study aims to compare the effects of immediate full weight-bearing versus partial weight-bearing for six weeks following a tibial shaft fracture treated with intramedullary nailing. The primary outcomes include the rate of return to work and scores from the physical component scale of the SF-36 questionnaire. Participants will be adults aged 18-65 who have sustained specific types of tibial fractures and have undergone surgery within 72 hours of admission. The study will assess the effectiveness of these two rehabilitation approaches in promoting recovery.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with acute, noncomminuted diaphyseal tibial fractures treated with intramedullary nailing.

Not a fit: Patients with severe medical comorbidities, open fractures, or those unable to complete questionnaires may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into optimal rehabilitation strategies that enhance recovery and return to daily activities for patients with tibial shaft fractures.

How similar studies have performed: Other studies have explored weight-bearing protocols in fracture rehabilitation, indicating potential benefits, but this specific comparison is less commonly tested.

Eligibility criteria

Inclusion Criteria:

* AO/OTA 42-A/B acute, noncomminuted diaphyseal fracture of the tibia treated with intramedullary nailing with or without posterior malleolus screw fixation
* operated within 72 hours of admittance
* age between 18-65 years

Exclusion Criteria:

* the inability to fill out the Finnish versions of the questionnaires
* previous arthroplasty of the knee or the ankle of the fractured limb
* previous ipsilateral below-knee fracture requiring surgical treatment or ankle arthrodesis
* inability to co-operate
* not living independently (institutionalized living before fracture)
* open fracture (Gustilo grade 2 or over)
* pathologic or stress fracture
* multiple fractures requiring operative treatment in polytrauma patient
* severe medical comorbidity impairing daily activities (inability to go climb three floors without assistance and stopping)
* Body Mass Index over 40
* unacceptably high risk of surgery due to severe medical comorbidities
* severe substance abuse
* patient is retired
* age is less than 18 or more than 65
* patient required a fasciotomy due to acute compartment syndrome during or after index surgery
* inability to walk before fracture or a daily need of walking aid, such as crutches

Where this trial is running

Jyväskylä, Central Finland and 2 other locations

• Central Finland Hospital Nova — Jyväskylä, Central Finland, Finland (NOT_YET_RECRUITING)
• Tampere Univeristy Hospital — Tampere, Pirkanmaa, Finland (RECRUITING)
• Turku University Hospital — Turku, Southwest Finland, Finland (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Aleksi Reito, Assoc prof — Tampere University Hospital
• Study coordinator: Aleksi Reito, Assoc prof

Conditions: Tibia Fracture, intramedullary nail, weight-bearing