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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc. ( Smith & Nephew Orthopaedics AG )
ClinicalTrials.gov Identifier:
NCT01358292
First received: January 14, 2011
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

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

Condition Intervention Phase
Tibial Fractures
Procedure: Semi-extended Surgical Technique
Procedure: Standard Surgical Technique
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Semi-extended Position vs. 90 Degrees of Flexion for Intramedullary Nailing of the Tibia: a Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Smith & Nephew, Inc.:

Primary Outcome Measures:
  • Anterior Knee Pain [ Time Frame: 4, 6 and 12 months post-operative ] [ Designated as safety issue: No ]
    Anterior Knee pain will be measured through a Kneeling test (time a patient is able to rest on his operated knee)


Secondary Outcome Measures:
  • Nail positioning [ Time Frame: Operation (day 1) ] [ Designated as safety issue: Yes ]
    Measure by means of fluoroscopy and standard x-rays during the surgery, the position of both the guide wire and the intramedullary nail.


Estimated Enrollment: 200
Study Start Date: February 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Trigen META intramedullary tibia nailing

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01358292

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

No publications provided

Responsible Party: Smith & Nephew, Inc. ( Smith & Nephew Orthopaedics AG )
ClinicalTrials.gov Identifier: NCT01358292     History of Changes
Other Study ID Numbers: R11021-1
Study First Received: January 14, 2011
Last Updated: February 26, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Smith & Nephew, Inc.:
Intramedullary tibia nailing
Anterior Knee Pain
Nail positioning

Additional relevant MeSH terms:
Tibial Fractures
Fractures, Bone
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on September 22, 2014