Nail Versus Sliding Hip Screw for Trochanteric Hip Fractures

NCT03172923 | Completed

• 1 other identifier: REC 10/H0306/66
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hip Injuries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• mortality

  at one year from injury

Study Arms (2)

sliding hip screw

ACTIVE COMPARATOR

fixation of fracture with a sliding hip screw

Device: sliding hip screw

intramedullary nail

EXPERIMENTAL

fixation of the fracture with an intramedullary nail

Device: intramedullary nial

Interventions

sliding hip screw DEVICE

fixation of the fracture with a sliding hip screw

sliding hip screw

intramedullary nial DEVICE

fixation of the fracture with an intramedullary nail

intramedullary nail

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peterborough and Stamford Hospitals NHS Foundation Trust: lead

MeSH Terms

Conditions

Hip Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: outcome assessor is blinded to treatment given
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant orthopaedic surgeon

Model Details: randomised controlled trial

Study Record Dates

• First Submitted: May 26, 2017
• First Posted: June 1, 2017
• Study Start: October 8, 2010
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2017
• Last Updated: September 19, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share