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

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

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

Study Overview

• Status: Completed
• Conditions: Tibial Fractures
• Intervention / Treatment: Procedure: Semi-extended Surgical Technique; Procedure: Standard Surgical Technique

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Würselen, Germany, 52146
    • Medizinisches Zentrum StädteRegion Aachen
• Spain
  • Madrid, Spain, 28041
    • Hoisptal de 12 Octubre
  • Valencia, Spain, 46009
    • Hospital La Fe
• United Kingdom
  • Nottingham, United Kingdom, NG7 2UH
    • Nottingham University Hospitals
  • Scotland
    • Aberdeen, Scotland, United Kingdom, AB25 2ZN
      • Aberdeen Royal Infirmary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Smith & Nephew Orthopaedics AG
• Investigators: Principal Investigator: Alan Johnstone, Professor, Aberdeen Royal Infirmary; Study Chair: Pedro Caba, Dr., Hospital de 12 Octubre, Madrid; Study Chair: Markus Graf, Dr., Medizinisches Zentrum StädteRegion Aachen; Study Chair: Ismael Escriba, Dr., Hospital La Fe Valencia; Study Chair: Daren Forward, MA, FRCS, DM, Nottingham University Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: January 14, 2011
• First Submitted That Met QC Criteria: May 20, 2011
• First Posted (Estimate): May 23, 2011

Study Record Updates

• Last Update Posted (Estimate): June 17, 2016
• Last Update Submitted That Met QC Criteria: June 16, 2016
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Anterior Knee Pain; Intramedullary tibia nailing; Nail positioning
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Tibial Fractures
• Other Study ID Numbers: R11021-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No