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

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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: 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.

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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