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
About this trial
This is an interventional treatment trial for Hip Injuries
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
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
NCT ID
NCT03172923
First Posted
May 26, 2017
Last Updated
September 18, 2017
Sponsor
Peterborough and Stamford Hospitals NHS Foundation Trust
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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