Effect of Transverse versus Longitudinal Incisions on Anterior Knee Pain after Tibial Nailing (TRAVEL); a multicenter randomized trial

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.



AIM

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.



STUDY DESIGN

Multi-center randomized controlled trial. Approximately 10 hospitals in the Netherlands will participate.



POPULATION

Patients between 16 and 65 years of age with a tibial shaft fracture amenable to surgical treatment with an intramedullary nail are eligible.


INTERVENTIONS

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.



ENDPOINTS

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.



RECRUITING COUNTRIES

The Netherlands

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.

Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months

1) Longitudinal incision and insertion of tibia nail using a transpatellar approach;

2) Transverse incision and insertion of tibia nail using a transpatellar approach