Efficacy Study of Surgical Technique in Intramedullary Tibia Nailing, Using Trigen META Tibia Nails (TrigenMETA)
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|ClinicalTrials.gov Identifier: NCT01358292|
Recruitment Status : Completed
First Posted : May 23, 2011
Last Update Posted : June 17, 2016
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
|Condition or disease||Intervention/treatment||Phase|
|Tibial Fractures||Procedure: Semi-extended Surgical Technique Procedure: Standard Surgical Technique||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||95 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Semi-extended Position vs. 90 Degrees of Flexion for Intramedullary Nailing of the Tibia: a Randomized Clinical Trial|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||October 2015|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|