Effect of Transverse versus Longitudinal Incisions on Anterior Knee Pain after Tibial Nailing (TRAVEL); a multicenter randomized trial
Recruiting
- Conditions
- Tibia shaft fractures
- Registration Number
- NL-OMON23839
- Lead Sponsor
- Erasmus MC, University Medical Center Rotterdam, Trauma Research Unit, Department of SurgeryErasmus Medical Center, Medical Research Ethics Committee (MREC)
- Brief Summary
one yet; study is ongoing
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 136
Inclusion Criteria
1. Age between 16 and 65 years
2.Unilateral tibial shaft fracture (AO 42 A, B and C)
Exclusion Criteria
1. Polytrauma patients, when concurring injury affect treatment and recovery
2. Patients with bilateral tibial fractures
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Kneeling pain (Numeric Rating Scale)
- Secondary Outcome Measures
Name Time Method Knee pain scores (NRS) for specific daily activities (including running, walking, jumping, stair climbing, squatting, sitting with flexed knees, and cycling); Functional outcome and health-related quality of life (SMFA and LEFS); Time to return to daily activities and work; Costs for health care and production losses; Range of motion of the knee and ankle; Nail prominence; Rate of complications; Rate of secondary interventions; Cosmesis (5-point scale); Cost-effectiveness