Short Versus Standard Intramedullary Nail for Trochanteric Hip Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02680028
Recruitment Status : Recruiting
First Posted : February 11, 2016
Last Update Posted : June 1, 2017
Information provided by (Responsible Party):
Martyn J Parker, Peterborough and Stamford Hospitals NHS Foundation Trust

Brief Summary:

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

Detailed Description:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All patients admitted to Peterborough City Hospital with a trochanteric hip fracture (type A1 type A2) that is to be treated by internal fixation with an intramedullary nail.

Exclusion Criteria:

  • Patients who decline to participate or in whom consent or assent is not available

    • Patients admitted when MJP is not available to supervise treatment
    • Patients with pathological fractures from Paget's disease of bone secondaries from tumour
    • Patients with a Subtrochanteric fracture and those of the reversed and transverse fracture type (A3 fractures)

Information from the National Library of Medicine

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 identifier (NCT number): NCT02680028

Contact: martyn j parker 441733678000

United Kingdom
Peterbrough City Hospital Recruiting
Peterborough, United Kingdom
Contact: martyn parker    441733678000   
Sponsors and Collaborators
Peterborough and Stamford Hospitals NHS Foundation Trust
Principal Investigator: martyn parker Peterborough hospital nhs trust

Responsible Party: Martyn J Parker, Consultant Orthopaedic Surgeon, Peterborough and Stamford Hospitals NHS Foundation Trust Identifier: NCT02680028     History of Changes
Other Study ID Numbers: R&D/2015/28
First Posted: February 11, 2016    Key Record Dates
Last Update Posted: June 1, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries