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

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Smith & Nephew

Status and phase

Phase 4


Tibial Fractures


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

Study type


Funder types




Details and patient eligibility


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

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.


95 patients




18 to 70 years old


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

95 participants in 2 patient groups

Semi-extended surgical technique
Experimental group
The experimental technique for implanting an intramedullary tibia nail is with the knee in 10-20 degrees of flexion.
Procedure: Semi-extended Surgical Technique
Standard Surgical Technique
Active Comparator group
The standard surgical technique in intramedullary tibia nailing is with the knee in almost 90 degrees of flexion.
Procedure: Standard Surgical Technique

Trial contacts and locations



Data sourced from clinicaltrials.gov

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