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

Smith & Nephew

Status and phase: Completed; Phase 4

Conditions: Tibial Fractures

Treatments: Procedure: Standard Surgical Technique; Procedure: Semi-extended Surgical Technique

Study type: Interventional

Funder types: Industry

Identifiers

NCT01358292

R11021-1

Details and patient eligibility

About

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:

1. Nail positioning by means of intra-operative fluoroscopy and post operative x-rays.
2. Anterior Knee pain by means of VAS-scores, a Kneeling test and Subjective outcomes by means of Patient questionnaires
3. Knee-related adverse events
4. Overall fracture alignment

Full description

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.

Enrollment: 95 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

95 participants in 2 patient groups

Semi-extended surgical technique

Experimental group

Description:

The experimental technique for implanting an intramedullary tibia nail is with the knee in 10-20 degrees of flexion.

Treatment:

Procedure: Semi-extended Surgical Technique

Standard Surgical Technique

Active Comparator group

Description:

The standard surgical technique in intramedullary tibia nailing is with the knee in almost 90 degrees of flexion.

Treatment:

Procedure: Standard Surgical Technique