Fixation Versus Arthroplasty for Undisplaced Intracapsular Fractures

Hip Fractures Clinical Trial

Official title:

Fixation Versus Arthroplasty for Undisplaced Intracapsular Fractures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02996383
• Other study ID #: R&D/2016/05
• Status: Recruiting
• Phase: N/A
• First received: June 10, 2016
• Last updated: December 16, 2016
• Start date: May 2016

Study information

• Verified date: December 2016
• Source: Peterborough and Stamford Hospitals NHS Foundation Trust
• Contact: martyn parker
• Phone: 441733678000
• Email: martyn.parker[@]pbh-tr.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures
• Undisplaced Intracapsular Hip Fracture

Intervention

Device:
• Internal fixation
Internal fixation of the fracture with a Targon FN implant (BBraun Ltd, Germany)
• Cemented Hemiarthroplasty
Replacement of the femoral head with a cemented hemiarthroplasty

Locations

Country	Name	City	State
United Kingdom	Peterborough and Stamford Hospital NHS Foundation Trust	Peterborough	Cambs

Sponsors (1)

Lead Sponsor	Collaborator
Peterborough and Stamford Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.)	one year	No