Efficacy Study of Surgical Technique in Intramedullary Tibia Nailing, Using Trigen META Tibia Nails (TrigenMETA)
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)
The primary research objectives are to evaluate:
i) anterior knee pain and ii) the nail position and overall fracture alignment
- 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
|Tibial Fractures||Procedure: Semi-extended Surgical Technique Procedure: Standard Surgical Technique||Phase 4|
|Study Design:||Allocation: Randomized
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|
- Anterior Knee Pain [ Time Frame: 4, 6 and 12 months post-operative ]Anterior Knee pain will be measured through a Kneeling test (time a patient is able to rest on his operated knee)
- Nail positioning [ Time Frame: Operation (day 1) ]Measure by means of fluoroscopy and standard x-rays during the surgery, the position of both the guide wire and the intramedullary nail.
|Study Start Date:||February 2011|
|Study Completion Date:||October 2015|
|Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01358292
|Medizinisches Zentrum StädteRegion Aachen|
|Würselen, Germany, 52146|
|Hoisptal de 12 Octubre|
|Madrid, Spain, 28041|
|Hospital La Fe|
|Valencia, Spain, 46009|
|Aberdeen Royal Infirmary|
|Aberdeen, Scotland, United Kingdom, AB25 2ZN|
|Nottingham University Hospitals|
|Nottingham, United Kingdom, NG7 2UH|
|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|