Short Versus Standard Intramedullary Nail for Trochanteric Hip Fractures
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|ClinicalTrials.gov Identifier: NCT02680028|
Recruitment Status : Recruiting
First Posted : February 11, 2016
Last Update Posted : June 1, 2017
In England each year over 65,000 people fracture their hip. Most of these patients are elderly females with the fracture occurring after a simple trip or stumble. Approximately half of these fractures are classified from their relationship to the hip joint capsule as extracapsular. The majority of these fractures are treated surgically by internal fixation using, either a plate and screws (sliding hip screw) or nail and screws (intramedullary nail).
Recent randomised studies from Peterborough involving 1000 patients have indicated that there are modest benefits for treating this type of fracture with an intramedullary nail in comparison to a sliding hip screw. This study aims to progress from these earlier studies to determine if a slightly thinner and shorter intramedullary nail (175mm in length), has any significant advantages or disadvantages to the standard length (220mm) intramedullary nail.
Both implants to be used in this study are in routine use around the world and are being used within their licenced indication. The study is therefore using two different designs of implant within their recommended area of use, but in which there is uncertainty as to which is the best design.
|Condition or disease||Intervention/treatment||Phase|
|Hip Fracture||Device: targon pft nail||Not Applicable|
The trial will be run as close to the ideal trial methodology for a randomised trial as specified by the CONSORT statement as possible. This will include secure randomisation, intention to treat analysis, full reporting of outcomes and clinical follow-up by a person who is blinded to the prosthesis used. The trial will follow the code of good clinical practice as specified by the hospital trusts Research and Development Committee.
In Peterborough all hip fracture patients are admitted to the acute trauma ward and transferred to the care of the Chief Investigator (Mr Martyn Parker (MJP)). Those patients that are willing to participant in this randomised trial are consented prior to surgery. Treatment follows standard evidence based protocols with follow-up of all patients in a hip fracture clinic. A comprehensive database is maintained for all patients containing both audit and research data. Included in this is a standardised assessment of outcome.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Randomised Trial of Trochanteric Hip Fractures Treated With Either a Short or Standard Length Intramedullary Nail|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Active Comparator: Standard length intramedullary nail
220mm intramedullary nail
Device: targon pft nail
Experimental: Short length intramedullary nail
175mm intramedullary nail
Device: targon pft nail
- Regain of mobility as assessed by a mobility score [ Time Frame: 1 year ]
Parker MJ, Palmer CR. A new mobility score for predicting mortality after hip fracture. J Bone Joint Surg Br. 1993;75:797-8.
Validation Kristensen MT, Bandholm T, Foss NB, Ekdahl C, Kehlet H. High inter-tester reliability of the new mobility score in patients with hip fracture. J Rehabil Med 2008;40:589-91.
Mobility will be assessed using a scale of 0 to 9. Nine represents full mobility indoors and outdoors without walking aids; Zero represents a bed-bound patient.
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): NCT02680028
|Contact: martyn j email@example.com|
|Peterbrough City Hospital||Recruiting|
|Peterborough, United Kingdom|
|Contact: martyn parker 441733678000 Martyn.firstname.lastname@example.org|
|Principal Investigator:||martyn parker||Peterborough hospital nhs trust|