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Completed

NCT Number: NCT01358292

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

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medizinisches Zentrum StädteRegion Aachen, Würselen, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Semi-extended Surgical Technique

Procedure

Surgical technique with the knee in 10-20 degrees of flexion, to implant the intramedullary tibia nail.

Other names: Trigen META Intramedullray Tibia Nail

Standard surgical technique

Procedure

Th e Standard surgical techique is implanting the tibia nail with the knee in 90 degrees of flexion.

Other names: Trigen META intramedullary tibia nailing

Primary outcomes

  1. Anterior Knee Pain

    Time frame: 4, 6 and 12 months post-operative

    Anterior Knee pain will be measured through a Kneeling test (time a patient is able to rest on his operated knee)

Secondary outcomes

  1. Nail positioning

    Time frame: Operation (day 1)

    Measure by means of fluoroscopy and standard x-rays during the surgery, the position of both the guide wire and the intramedullary nail.

Sponsors and collaborators

Lead sponsor

Smith & Nephew Orthopaedics AG

Industry

Registry information

Official study title

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

Acronym: TrigenMETA

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
May 23, 2011
Registry last updated
Jun 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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