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

Tibial Fractures Clinical Trial

— TrigenMETA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01358292
• Other study ID #: R11021-1
• Status: Completed
• Phase: Phase 4
• First received: January 14, 2011
• Last updated: June 16, 2016
• Start date: February 2011
• Est. completion date: October 2015

Study information

• Verified date: November 2015
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tibial Fractures

Intervention

Procedure:
• Semi-extended Surgical Technique
Surgical technique with the knee in 10-20 degrees of flexion, to implant the intramedullary tibia nail.
• Standard Surgical Technique
Th e Standard surgical techique is implanting the tibia nail with the knee in 90 degrees of flexion.

Locations

Country	Name	City	State
Germany	Medizinisches Zentrum StädteRegion Aachen	Würselen
Spain	Hoisptal de 12 Octubre	Madrid
Spain	Hospital La Fe	Valencia
United Kingdom	Aberdeen Royal Infirmary	Aberdeen	Scotland
United Kingdom	Nottingham University Hospitals	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew Orthopaedics AG

Countries where clinical trial is conducted

Germany,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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)	Yes