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Nail Versus Sliding Hip Screw for Trochanteric Hip Fractures

Primary Purpose

Hip Injuries

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
sliding hip screw
intramedullary nial
Sponsored by
Peterborough and Stamford Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Injuries

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients admitted to Peterborough District Hospital with a trochanteric hip fracture that is to be treated by internal fixation.

Exclusion Criteria:

  • Patients who decline to participate
  • Patients without the capacity to give informed consent
  • Patients admitted when MJP is not available to supervise treatment
  • Patients with pathological fractures from Paget's disease of bone secondaries from tumour

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    sliding hip screw

    intramedullary nail

    Arm Description

    fixation of fracture with a sliding hip screw

    fixation of the fracture with an intramedullary nail

    Outcomes

    Primary Outcome Measures

    regain of mobility
    regain of walking ability using a standardised mobility score (Parker MJ, Palmer CR. A new mobility score for predicting mortality after hip fracture. J Bone Joint Surg 1993;75-B:797-8.)

    Secondary Outcome Measures

    mortality
    mortality

    Full Information

    First Posted
    May 26, 2017
    Last Updated
    September 18, 2017
    Sponsor
    Peterborough and Stamford Hospitals NHS Foundation Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03172923
    Brief Title
    Nail Versus Sliding Hip Screw for Trochanteric Hip Fractures
    Official Title
    Randomised Trial of Trochanteric Hip Fractures Treated With Either a Sliding Hip Screw on an Intramedullary Nail
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 8, 2010 (Actual)
    Primary Completion Date
    September 1, 2016 (Actual)
    Study Completion Date
    September 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Peterborough and Stamford Hospitals NHS Foundation Trust

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The investigators therefore propose to undertake a further randomised controlled trial comparing the sliding hip screw (SHS) with the Targon PFT intramedullary nail. The aim is to see if the summation of the first trial of 600 participants comparing the sliding hip screw with the Targon PF nails, in conjunction with this study of 400 participants with the updated Targon PFT nail produces results that convincingly demonstrate that this particular design of implant is superior to the sliding hip screw. Because of the financial issues involved a cost benefit comparison for the two procedures is planned at the completion of the study. Primary outcome measures will be regain of walking ability. Secondary outcome measures recorded with include mortality, length of surgery, operative blood loss, blood transfusion, post-operative complications, hospital stay, need for subsequent revision surgery and degree of residual pain.
    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 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 MJP. Those patients that are willing to participant in one of our randomised trials 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. The sliding hip screw used if of a standard design that has been in use at Peterborough for the last fifty years. The intramedullary nails used will be the Targon PFT nail. This nail is very similar to the Targon PF nail used in the earlier trial on this topic. Bases on the results of the previous study and the experience of other users the nail has undergone minor modifications that are primarily aimed at making the nail easier to use with improved instrumentation and also a change to design of the cross screw aimed at reducing the risk of fracture fixation complications occurring.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hip Injuries

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    randomised controlled trial
    Masking
    Outcomes Assessor
    Masking Description
    outcome assessor is blinded to treatment given
    Allocation
    Randomized
    Enrollment
    400 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    sliding hip screw
    Arm Type
    Active Comparator
    Arm Description
    fixation of fracture with a sliding hip screw
    Arm Title
    intramedullary nail
    Arm Type
    Experimental
    Arm Description
    fixation of the fracture with an intramedullary nail
    Intervention Type
    Device
    Intervention Name(s)
    sliding hip screw
    Intervention Description
    fixation of the fracture with a sliding hip screw
    Intervention Type
    Device
    Intervention Name(s)
    intramedullary nial
    Intervention Description
    fixation of the fracture with an intramedullary nail
    Primary Outcome Measure Information:
    Title
    regain of mobility
    Description
    regain of walking ability using a standardised mobility score (Parker MJ, Palmer CR. A new mobility score for predicting mortality after hip fracture. J Bone Joint Surg 1993;75-B:797-8.)
    Time Frame
    one year from injury
    Secondary Outcome Measure Information:
    Title
    mortality
    Description
    mortality
    Time Frame
    at one year from injury

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All patients admitted to Peterborough District Hospital with a trochanteric hip fracture that is to be treated by internal fixation. Exclusion Criteria: Patients who decline to participate Patients without the capacity to give informed consent Patients admitted when MJP is not available to supervise treatment Patients with pathological fractures from Paget's disease of bone secondaries from tumour

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Nail Versus Sliding Hip Screw for Trochanteric Hip Fractures

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