Efficacy Study of Surgical Technique in Intramedullary Tibia Nailing, Using Trigen META Tibia Nails

Study Overview
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Brief Summary
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Multicentre Prospective Randomized Clinical Trial, to evaluate patients after surgery for extra-articular tibial fractures treated with Smith& Nephew's Trigen META intramedullary nailing system; comparing two surgical techniques: Group A=standard technique(90º of knee flexion) and Group B=with the semi-extended surgical technique. (2*100 patients) Research Objectives: The primary research objectives are to evaluate: i) anterior knee pain and ii) the nail position and overall fracture alignment Outcome Measures: Nail positioning by means of intra-operative fluoroscopy and post operative x-rays. Anterior Knee pain by means of VAS-scores, a Kneeling test and Subjective outcomes by means of Patient questionnaires Knee-related adverse events Overall fracture alignment

Detailed Description
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After surgery with standard intramedullary nailing technique in tibia fractures, 40-80% of the patients still complain of anterior knee pain postoperative. The expected advantages of the semi-extended nailing technique is less anterior knee pain and less malunion of the fracture. Using the semi-extended nailing technique also might give the advantage of better position of the nail by a more concentric reaming of the tibia, due to less tension on the patella tendon during reaming process.

Official Title
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Semi-extended Position vs. 90 Degrees of Flexion for Intramedullary Nailing of the Tibia: a Randomized Clinical Trial

Conditions
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Tibial Fractures

Intervention / Treatment
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* Procedure: Semi-extended Surgical Technique
* Procedure: Standard Surgical Technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has sustained a closed (Tscherne Classification) or open tibial fracture (Gustillo-Anderson Classification) that is amendable for operative fixation with an intramedullary nail. Patient has an isolated tibia and fibula fracture Skeletally mature Patients aged between/including 18 to 70 years Patient has given formal consent to be involved in the trial and has completed the study consent form Patient is likely to comply with study follow-up requirements Exclusion Criteria: Pathologic fractures Other fractures involving the same lower extremity Soft tissue injuries/problems that would prevent the surgeon from using both of the surgical techniques to insert an intramedullary nail Patient having pre-existing knee joint disease causing anterior knee pain Patient likely to have problems with follow-up Patient unwilling to give informed consent to be included in the trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Semi-extended surgical technique<br>The experimental technique for implanting an intramedullary tibia nail is with the knee in 10-20 degrees of flexion. | Procedure: Semi-extended Surgical Technique<br>* Surgical technique with the knee in 10-20 degrees of flexion, to implant the intramedullary tibia nail.<br>* Other names: Trigen META Intramedullray Tibia Nail;|
| Active Comparator: Standard Surgical Technique<br>The standard surgical technique in intramedullary tibia nailing is with the knee in almost 90 degrees of flexion. | Procedure: Standard Surgical Technique<br>* Th e Standard surgical techique is implanting the tibia nail with the knee in 90 degrees of flexion.<br>* Other names: Trigen META intramedullary tibia nailing;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anterior Knee Pain | Anterior Knee pain will be measured through a Kneeling test (time a patient is able to rest on his operated knee) | 4, 6 and 12 months post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nail positioning | Measure by means of fluoroscopy and standard x-rays during the surgery, the position of both the guide wire and the intramedullary nail. | Operation (day 1) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intramedullary tibia nailing, Anterior Knee Pain, Nail positioning