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Fixation Versus Arthroplasty for Undisplaced Intracapsular Fractures

Primary Purpose

Hip Fractures, Undisplaced Intracapsular Hip Fracture

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Internal fixation
Cemented Hemiarthroplasty
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 Fractures focused on measuring arthroplasty

Eligibility Criteria

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

Inclusion Criteria:

  • All patients admitted to Peterborough and Stamford Hospitals NHS Foundation Trust with an undisplaced intracapsular fracture will be considered for inclusion within the study. Patients who lack Capacity for example dementia who are unable to provide informed consent will be included if the assent of their next of kin or legal guardian can be obtained.

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 secondary's from tumour
    • patients with delayed presentation who would be treated conservatively
    • patients considered unfit for either surgical procedure
    • younger patients, aged less than 80 years who are independently mobile and very active will be excluded at treated by internal fixation (the risk of fracture healing complication for this group is less, whilst there is an increased risk of long term complications after arthroplasty

Sites / Locations

  • Peterborough and Stamford Hospital NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cemented hemiarthroplasty

Internal fixation

Arm Description

Treatment of the fracture by a replacement arthroplasty with a cemented CPT hemiarthroplasty (manafactured by Zimmer company, Warsaw IN, USA) inserted via an anteriolateral approach to the hip

Internal fixation of the fracture with a screw and plate device (Targon FN plate, Aesculap cooperation, Tuttingham, Germany)

Outcomes

Primary Outcome Measures

regain of mobility using the Parker and Palmer mobility scale
Assessment is using the Parker and Palmer 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.)

Secondary Outcome Measures

Full Information

First Posted
June 10, 2016
Last Updated
December 16, 2016
Sponsor
Peterborough and Stamford Hospitals NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02996383
Brief Title
Fixation Versus Arthroplasty for Undisplaced Intracapsular Fractures
Official Title
Fixation Versus Arthroplasty for Undisplaced Intracapsular Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In England each year over 70,000 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 intracapsular. These fractures are subdivided into those that are displaced and those that are undisplaced. The majority of displaced fractures are treated with a replacement arthroplasty. Current treatment for the undisplaced fractures is generally by internal fixation of the fracture using screws and a plate, although some centres prefer replacement arthroplasty. A recent randomised study on patients from Norway with undisplaced intracapsular fractures treated with either internal fixation or arthroplasty has just reported reduced complications and re-operations for those patients treated with an arthroplasty. In addition functional results were marginally better for those patients treated with an arthroplasty. Current practice in the UK is generally to treat these fractures by internal fixation. This study aims to see if replacement arthroplasty can indeed lead to the advantages suggested from the Norwegian study. Patients who satisfy the inclusion criteria and are willing to participate will be randomised to receive either reduction and internal fixation of the fracture with a screw and plate device or alternatively replacement of their femoral head with an artificial hip replacement (hemiarthroplasty). After surgery patients will receive the same treatment as normal and be discharge home when able, with follow-up review in the hip fracture clinic. Subsequent follow-up for the research project is by phone calls from a research nurse who is blinded to the type of treatment that the patient has received. There will be no additional investigations or out-patient follow-up visits for these patients in comparison to normal treatment protocols. Results of the study will ultimately be published in a medical journal.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures, Undisplaced Intracapsular Hip Fracture
Keywords
arthroplasty

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Cemented hemiarthroplasty
Arm Type
Active Comparator
Arm Description
Treatment of the fracture by a replacement arthroplasty with a cemented CPT hemiarthroplasty (manafactured by Zimmer company, Warsaw IN, USA) inserted via an anteriolateral approach to the hip
Arm Title
Internal fixation
Arm Type
Active Comparator
Arm Description
Internal fixation of the fracture with a screw and plate device (Targon FN plate, Aesculap cooperation, Tuttingham, Germany)
Intervention Type
Device
Intervention Name(s)
Internal fixation
Intervention Description
Internal fixation of the fracture with a Targon FN implant (BBraun Ltd, Germany)
Intervention Type
Device
Intervention Name(s)
Cemented Hemiarthroplasty
Intervention Description
Replacement of the femoral head with a cemented hemiarthroplasty
Primary Outcome Measure Information:
Title
regain of mobility using the Parker and Palmer mobility scale
Description
Assessment is using the Parker and Palmer 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.)
Time Frame
one 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 and Stamford Hospitals NHS Foundation Trust with an undisplaced intracapsular fracture will be considered for inclusion within the study. Patients who lack Capacity for example dementia who are unable to provide informed consent will be included if the assent of their next of kin or legal guardian can be obtained. 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 secondary's from tumour patients with delayed presentation who would be treated conservatively patients considered unfit for either surgical procedure younger patients, aged less than 80 years who are independently mobile and very active will be excluded at treated by internal fixation (the risk of fracture healing complication for this group is less, whilst there is an increased risk of long term complications after arthroplasty
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
martyn parker
Phone
441733678000
Email
martyn.parker@pbh-tr.nhs.uk
Facility Information:
Facility Name
Peterborough and Stamford Hospital NHS Foundation Trust
City
Peterborough
State/Province
Cambs
ZIP/Postal Code
PE36DA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martyn J Parker, MD
Phone
441733874000
Ext
4193
Email
Martyn.Parker@pbh-tr.nhs.uk

12. IPD Sharing Statement

Learn more about this trial

Fixation Versus Arthroplasty for Undisplaced Intracapsular Fractures

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