|- candidate number||21785|
|- NTR Number||NTR5091|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-mrt-2015|
|- Secondary IDs||MEC-2014-335 NL49144.078.14|
|- Public Title||Effect of Transverse versus Longitudinal Incisions on Anterior Knee Pain after Tibial Nailing (TRAVEL); a multicenter randomized trial|
|- Scientific Title||Effect of Transverse versus Longitudinal Incisions on Anterior Knee Pain after Tibial Nailing (TRAVEL); a multicenter randomized trial|
|- hypothesis||The main study hypothesis is that by reducing the risk of transsection of the infrapatellar nerve during tibial nailing, post-operative anterior knee pain can be reduced. At one year, we expect less anterior knee pain and better functional status in patients treated with a transverse incision than in patients treated with a longitudinal incision. We also expect fewer complication and less health care use in the transverse incision group. Given these expected differences, the transverse incision is expected to be more cost-effective.|
|- Healt Condition(s) or Problem(s) studied||Tibia, Fracture |
|- Inclusion criteria||1. Age between 16 and 65 years|
2.Unilateral tibial shaft fracture (AO 42 A, B and C)
3. Indication for intramedullary nailing in judgment of the treating surgeon (within 2 weeks after initial trauma)
4. Provided written consent by patient
|- Exclusion criteria||1. Polytrauma patients, when concurring injury affect treatment and recovery|
2. Patients with bilateral tibial fractures
3. Patients with a pathological or recurrent fracture of the tibia
4. Gustilo open fractures grade C or open wound on knee
5. Patients with pre-existing knee pathology (e.g., menisci, cruciate ligament)
6. Patients with pre-existing functional impairment which has influence on rehabilitation (e.g. wheelchair-bound)
7. Patients with rheumatoid arthritis
8. Patients with bone disease resulting in delayed union (except osteoporosis)
9. Insufficient comprehension of Dutch language to adhere to treatment guidelines
10. Likely problems with follow-up (e.g., no fixed address)
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2015|
|- planned closingdate||1-mei-2017|
|- Target number of participants||136|
|- Interventions||1) Longitudinal incision and insertion of tibia nail using a transpatellar approach;|
2) Transverse incision and insertion of tibia nail using a transpatellar approach
|- Primary outcome||Kneeling pain (Numeric Rating Scale)|
|- Secondary outcome||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|
|- Timepoints||Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months|
|- Trial web site||None|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD PhD M.H.J. Verhofstad|
|- CONTACT for SCIENTIFIC QUERIES||MD PhD M.H.J. Verhofstad|
|- Sponsor/Initiator ||Erasmus Medical Center, Medical Ethical Committee (METC), Erasmus MC, Trauma Research Unit department of Surgery|
(Source(s) of Monetary or Material Support)
|AO Research Foundation, Switzerland|
|- Publications||None yet; study is ongoing|
|- Brief summary||BACKGROUND|
Anterior knee pain is a common complaint after intramedullary nailing of the tibia. Iatrogenic injury to the infrapatellar nerve is thought to be a contributing cause in the trans- and parapatellar approach. We hypothesize that anterior knee pain after tibial nailing can be reduced by decreasing the risk of infrapatellar nerve injury.
The primary aim of this prospective, multicenter, trial is to assess the effect of a transverse versus a longitudinal transpatellar incision on anterior knee pain. Secondary aims are to assess the effect on functional outcome, pain during specific activities, health-related quality of life, ROM, complications, and cosmesis in these patients. The costs and cost-effectiveness of both interventions will be determined.
Multi-center randomized controlled trial. Approximately 10 hospitals in the Netherlands will participate.
Patients between 16 and 65 years of age with a tibial shaft fracture amenable to surgical treatment with an intramedullary nail are eligible.
Patients treated with a transpatellar approach will be equally randomized to a longitudinal or transverse incision. Critical elements of the operation will be recorded but not standardized. Due to a lack of evidence favoring a particular approach, the physical therapy and rehabilitation program will be recorded but not standardized. This allows for post-hoc analysis and improves generalization of the study results.
Primary outcome measure: kneeling pain based on a numeric rating scale (NRS) at 12 months post surgery
Secondary outcome measures: Knee pain scores (NRS) for daily activities; 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.
Primary and secondary outcomes will be compared at baseline, at 2 and 6 weeks, and at 3, 6, and 12 months after start of treatment, using both univariate and multivariable analyses. Costs for (in)formal healthcare consumption will be determined for both interventions, cost-effectiveness will be expressed as cost per quality of life year (QALY) gained.
|- Main changes (audit trail)|
|- RECORD||11-mrt-2015 - 25-apr-2015|