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

Primary Purpose

Tibial Fractures

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Semi-extended Surgical Technique

Standard Surgical Technique

About this trial

This is an interventional treatment trial for Tibial Fractures focused on measuring Intramedullary tibia nailing, Anterior Knee Pain, Nail positioning

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Medizinisches Zentrum StädteRegion Aachen
Hoisptal de 12 Octubre
Hospital La Fe
Aberdeen Royal Infirmary
Nottingham University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Semi-extended surgical technique

Standard Surgical Technique

Arm Description

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

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

Outcomes

Primary Outcome Measures

Anterior Knee Pain

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

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

Full Information

NCT ID

NCT01358292

First Posted

January 14, 2011

Last Updated

June 16, 2016

Sponsor

Smith & Nephew Orthopaedics AG

1. Study Identification

Unique Protocol Identification Number

NCT01358292

Brief Title

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

Acronym

TrigenMETA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

February 2011 (undefined)

Primary Completion Date

September 2015 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Smith & Nephew Orthopaedics AG

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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: Nail positioning by means of intra-operative fluoroscopy and post operative x-rays. Anterior Knee pain by means of VAS-scores, a Kneeling test and Subjective outcomes by means of Patient questionnaires Knee-related adverse events 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tibial Fractures

Keywords

Intramedullary tibia nailing, Anterior Knee Pain, Nail positioning

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

95 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Semi-extended surgical technique

Arm Type

Experimental

Arm Description

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

Arm Title

Standard Surgical Technique

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Semi-extended Surgical Technique

Other Intervention Name(s)

Trigen META Intramedullray Tibia Nail

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Standard Surgical Technique

Other Intervention Name(s)

Trigen META intramedullary tibia nailing

Intervention Description

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

Primary Outcome Measure Information:

Title

Anterior Knee Pain

Description

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

Time Frame

4, 6 and 12 months post-operative

Secondary Outcome Measure Information:

Title

Nail positioning

Description

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

Time Frame

Operation (day 1)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials: