Efficacy Study of Surgical Technique in Intramedullary Tibia Nailing, Using Trigen META Tibia Nails (TrigenMETA)
This study is currently recruiting participants.
Verified May 2011 by Smith & Nephew Orthopaedics AG
Sponsor:
Smith & Nephew Orthopaedics AG
Information provided by:
Smith & Nephew Orthopaedics AG
ClinicalTrials.gov Identifier:
NCT01358292
First received: January 14, 2011
Last updated: May 20, 2011
Last verified: May 2011
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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:
- 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
| Condition | Intervention | Phase |
|---|---|---|
|
Tibial Fractures |
Procedure: Semi-extended 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 Orthopaedics AG:
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: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (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: 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
|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01358292
Locations
| Germany | |
| Medizinisches Zentrum StädteRegion Aachen | Recruiting |
| Würselen, Germany, 52146 | |
| Contact: Markus Graf, Dr. +49 2405623313 markus.graf@mz-ac.de | |
| Principal Investigator: Markus Graf, MD | |
| Spain | |
| Hoisptal de 12 Octubre | Recruiting |
| Madrid, Spain, 28041 | |
| Contact: Pedro Caba, Dr. +34913908000 pedrocabado@gmail.com | |
| Principal Investigator: Pedro Caba, MD | |
| Hospital La Fe | Recruiting |
| Valencia, Spain, 46009 | |
| Contact: Ismael Escriba, Dr. 0034-639021922 iescribau@gmail.com | |
| Principal Investigator: Ismael Escriba, Phd | |
| United Kingdom | |
| Aberdeen Royal Infirmary | Recruiting |
| Aberdeen, Scotland, United Kingdom, AB25 2ZN | |
| Contact: Alan Johnstone, Prof +44 (1224) 556755 a.johnstone@nhs.net | |
| Principal Investigator: Alan Johnstone, Porf | |
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 |
More Information
No publications provided
| Responsible Party: | Smith & Nephew Orthopaedics AG, The sponsor |
| ClinicalTrials.gov Identifier: | NCT01358292 History of Changes |
| Other Study ID Numbers: | R11021-1 |
| Study First Received: | January 14, 2011 |
| Last Updated: | May 20, 2011 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by Smith & Nephew Orthopaedics AG:
|
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 May 16, 2013