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Fixation Versus Arthroplasty for Undisplaced Intracapsular Fractures

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ClinicalTrials.gov Identifier: NCT02996383
Recruitment Status : Recruiting
First Posted : December 19, 2016
Last Update Posted : December 19, 2016
Sponsor:
Information provided by (Responsible Party):
Martyn J Parker, Peterborough and Stamford Hospitals NHS Foundation Trust

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.


Condition or disease Intervention/treatment Phase
Hip Fractures Undisplaced Intracapsular Hip Fracture Device: Internal fixation Device: Cemented Hemiarthroplasty Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fixation Versus Arthroplasty for Undisplaced Intracapsular Fractures
Study Start Date : May 2016
Estimated Primary Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Cemented hemiarthroplasty
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
Device: Cemented Hemiarthroplasty
Replacement of the femoral head with a cemented hemiarthroplasty

Active Comparator: Internal fixation
Internal fixation of the fracture with a screw and plate device (Targon FN plate, Aesculap cooperation, Tuttingham, Germany)
Device: Internal fixation
Internal fixation of the fracture with a Targon FN implant (BBraun Ltd, Germany)




Primary Outcome Measures :
  1. regain of mobility using the Parker and Palmer mobility scale [ Time Frame: one year ]
    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.)



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02996383


Contacts
Contact: martyn parker 441733678000 martyn.parker@pbh-tr.nhs.uk

Locations
United Kingdom
Peterborough and Stamford Hospital NHS Foundation Trust Recruiting
Peterborough, Cambs, United Kingdom, PE36DA
Contact: Martyn J Parker, MD    441733874000 ext 4193    Martyn.Parker@pbh-tr.nhs.uk   
Sponsors and Collaborators
Peterborough and Stamford Hospitals NHS Foundation Trust

Responsible Party: Martyn J Parker, consultant orthopaedic surgeon, Peterborough and Stamford Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02996383     History of Changes
Other Study ID Numbers: R&D/2016/05
First Posted: December 19, 2016    Key Record Dates
Last Update Posted: December 19, 2016
Last Verified: December 2016

Keywords provided by Martyn J Parker, Peterborough and Stamford Hospitals NHS Foundation Trust:
arthroplasty

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries