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Short Versus Standard Intramedullary Nail for Trochanteric Hip Fractures

Primary Purpose

Hip Fracture

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
targon pft nail
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 Fracture

Eligibility Criteria

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

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)

Sites / Locations

  • Peterbrough City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard length intramedullary nail

Short length intramedullary nail

Arm Description

220mm intramedullary nail

175mm intramedullary nail

Outcomes

Primary Outcome Measures

Regain of mobility as assessed by a mobility score
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.

Secondary Outcome Measures

Full Information

First Posted
February 4, 2016
Last Updated
March 9, 2021
Sponsor
Peterborough and Stamford Hospitals NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02680028
Brief Title
Short Versus Standard Intramedullary Nail for Trochanteric Hip Fractures
Official Title
Randomised Trial of Trochanteric Hip Fractures Treated With Either a Short or Standard Length Intramedullary Nail
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
June 2019 (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
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.
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
229 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard length intramedullary nail
Arm Type
Active Comparator
Arm Description
220mm intramedullary nail
Arm Title
Short length intramedullary nail
Arm Type
Experimental
Arm Description
175mm intramedullary nail
Intervention Type
Device
Intervention Name(s)
targon pft nail
Intervention Description
220 mm vs 175mm nail
Primary Outcome Measure Information:
Title
Regain of mobility as assessed by a mobility score
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
martyn parker
Organizational Affiliation
Peterborough hospital nhs trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peterbrough City Hospital
City
Peterborough
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32114812
Citation
Parker MJ, Cawley S. Short (175 mm) versus standard (220 mm) length intramedullary nail for trochanteric hip fractures: a randomized trial of 229 patients. Bone Joint J. 2020 Mar;102-B(3):394-399. doi: 10.1302/0301-620X.102B3.BJJ-2019-0776.R3.
Results Reference
result

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Short Versus Standard Intramedullary Nail for Trochanteric Hip Fractures

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