Effect of transverse versus longitudinal incisions and suprapatellar approach on anterior knee pain after tibial nailing; a multicenter randomized trial
- Conditions
- anterior knee pain10017322
- Registration Number
- NL-OMON44985
- Lead Sponsor
- Erasmus MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
Age between 16 and 65 years
Unilateral tibial shaft fracture (AO 42 A, B and C)
Indication for intramedullary nailing in judgement of the treating surgeon (within 2 weeks after initial trauma)
Provided written informed consent by patient
Gustilo open fractures grade III-C or open wound on knee
Polytrauma patients, when concurring injury affect treatment and recovery
Patients with bilateral tibial shaft fractures
Patients with a pathological or recurrent fracture of the tibia
Patients with pre-existing knee pathology (e.g. menisci, cruciate ligament)
Patients with pre-existing functional impairment which has influence on rehabilitation (e.g. wheelchair-bound)
Patients with rheumatoid arthritis
Patients with bone disease resulting in delayed union (except osteoporosis)
Insufficient comprehension of Dutch language to adhere to treatment guidelines
Likely problems with follow-up (e.g. no fixed address)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome measure for the randomized trial is the difference in kneeling<br /><br>pain based on a numeric rating scale (NRS) at 12 months post-surgery between<br /><br>patients treated with a longitudinal and a transverse incision. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome measures for the randomized trial (transverse versus<br /><br>longitudinal incision) include differences at 12 months post-surgery between<br /><br>both groups for knee pain during daily activities, infrapatellar nerve injury,<br /><br>functional outcome and health care consumption. Outcome measures for the cohort<br /><br>study (suprapatellar approach) include all above mentioned parameters.</p><br>