Nail Versus Sliding Hip Screw for Trochanteric Hip Fractures

Hip Injuries Clinical Trial

Official title:

Randomised Trial of Trochanteric Hip Fractures Treated With Either a Sliding Hip Screw on an Intramedullary Nail

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03172923
• Other study ID #: REC 10/H0306/66
• Status: Completed
• Phase: N/A
• First received: May 26, 2017
• Last updated: September 18, 2017
• Start date: October 8, 2010
• Est. completion date: September 1, 2017

Study information

• Verified date: September 2017
• Source: Peterborough and Stamford Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: September 1, 2017
• Est. primary completion date: September 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Fractures
• Hip Injuries

Intervention

Device:
• sliding hip screw
fixation of the fracture with a sliding hip screw
• intramedullary nial
fixation of the fracture with an intramedullary nail

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peterborough and Stamford Hospitals NHS Foundation Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.)	one year from injury
Secondary	mortality	mortality	at one year from injury