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Effect of transverse versus longitudinal incisions and suprapatellar approach on anterior knee pain after tibial nailing; a multicenter randomized trial

Effect of transverse versus longitudinal incisions and suprapatellar approach on anterior knee pain after tibial nailing; a multicenter randomized trial - TRAVEL study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON44985
Enrollment
120
Registered
2014-10-15
Start date
2015-09-06
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

anterior knee pain

Interventions

Patients treated with a transpatellar approach will be equally randomized to a longitudinal or transverse incision.

Sponsors

Erasmus MC
Lead Sponsor

Eligibility

Age
12 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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)

Design outcomes

Primary

MeasureTime frame
Primary outcome measure for the randomized trial is the difference in kneeling pain based on a numeric rating scale (NRS) at 12 months post-surgery between patients treated with a longitudinal and a transverse incision.

Secondary

MeasureTime frame
Secondary outcome measures for the randomized trial (transverse versus longitudinal incision) include differences at 12 months post-surgery between both groups for knee pain during daily activities, infrapatellar nerve injury, functional outcome and health care consumption. Outcome measures for the cohort study (suprapatellar approach) include all above mentioned parameters.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)