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

NCT ID: NCT01358292

Last Updated: 2016-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2015-10-31

Brief Summary

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

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.

Conditions

Tibial Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Semi-extended surgical technique

The experimental technique for implanting an intramedullary tibia nail is with the knee in 10-20 degrees of flexion.

Group Type: EXPERIMENTAL

Semi-extended Surgical Technique

Intervention Type: PROCEDURE

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

Standard Surgical Technique

The standard surgical technique in intramedullary tibia nailing is with the knee in almost 90 degrees of flexion.

Group Type: ACTIVE_COMPARATOR

Standard Surgical Technique

Intervention Type: PROCEDURE

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

Interventions

Semi-extended Surgical Technique

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

Intervention Type: PROCEDURE

Standard Surgical Technique

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

Intervention Type: PROCEDURE

Other Intervention Names

Trigen META Intramedullray Tibia Nail; Trigen META intramedullary tibia nailing

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Smith & Nephew Orthopaedics AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alan Johnstone, Professor

Role: PRINCIPAL_INVESTIGATOR

Aberdeen Royal Infirmary

Pedro Caba, Dr.

Role: STUDY_CHAIR

Hospital de 12 Octubre, Madrid

Markus Graf, Dr.

Role: STUDY_CHAIR

Medizinisches Zentrum StädteRegion Aachen

Ismael Escriba, Dr.

Role: STUDY_CHAIR

Hospital La Fe de Valencia

Daren Forward, MA, FRCS, DM

Role: STUDY_CHAIR

Nottingham University Hospital

Locations

Medizinisches Zentrum StädteRegion Aachen

Würselen, , Germany

Hoisptal de 12 Octubre

Madrid, , Spain

Hospital La Fe

Valencia, , Spain

Aberdeen Royal Infirmary

Aberdeen, Scotland, United Kingdom

Nottingham University Hospitals

Nottingham, , United Kingdom

Countries

Germany; Spain; United Kingdom

Other Identifiers

R11021-1

Identifier Type: -

Identifier Source: org_study_id