Uncemented Versus Cemented Total Hip Arthroplasty for Displaced Intracapsular Hip Fractures

Not Applicable

Terminated

• Conditions: Hip Fractures
• Interventions: Device: Total hip arthroplasty

• Registration Number: NCT04372966
• Lead Sponsor: NHS Lothian

Brief Summary

Displaced subcapital hip fractures are very common and account for almost 50% of all hip fractures. The aim of the present study is to determine whether an uncemented total hip replacement is better than conventional cemented hip replacement to treat these fractures.

Detailed Description

Hip fractures account for 20% of all fractures and displaced subcapital fractures represent 45% of the hip fracture workload. All of these patients are treated with some form of hip replacement. Recent randomised trials have confirmed that total hip replacement is probably the best choice of treatment in a fit older patient and is better than partial hip replacement or repair of the fracture with screws which are the other most commonly used treatments. Hip replacements may be cemented or uncemented. The uncemented type of hip replacement has not been commonly used in this group of patients but may have some advantages. The uncemented hip replacement is a shorter operation and this may be advantageous in the hip fracture population group since these are older patients, many of whom have other medical problems. The use of cement is occasionally associated with development of heart problems during anaesthesia.

Participants: The original aim was to recruit 200 patients who have been admitted with a displaced subcapital hip fracture to the New Royal Infirmary and will undergo total hip replacement surgery within 48 hours of admission. Patients fitting the inclusion criteria will be given a patient information sheet and will be given between 24-48 hours to decide whether they give consent to participate in the trial. Patients who have given their consent will be randomly allocated to one of two groups i.e.. allocation to one of the two groups will entirely by chance. Each group will have 100 patients.

Intervention Both groups will received a total hip replacement. The only difference between the two groups is the type of hip replacement and the way it is fixed in the thigh bone. One type of hip replacement requires cement ('Exeter'), the other ('CORAIL' from DePuy) doesn't. Other surgical protocols and care after the surgery will be exactly the same for both groups.

Purpose The purpose of this research is to compare the clinical outcome (i.e. complications, revisions etc.) and the function of the patients between the two groups at several different time points: around 8 weeks, 4 months, 12 months and 24 months post surgery.

Outcome measures Clinical: Surgery complications, duration of surgery, readmissions, revision surgery, duration of hospital stay.

Study Timeline

• Study Start: 2009-09-24
• Primary Completion: 2011-12-29
• Study Completion: 2016-12-29
• Status Verified: 2020-04
• Study First Submitted: 2020-04-27
• Study First Submitted QC: 2020-04-29
• Last Update Submitted: 2020-04-29
• Study First Posted: 2020-05-04
• Last Update Posted: 2020-05-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• patients over the age of 60 years with a displaced intracapsular hip fracture and are admitted to the study centre and are under the care of four orthopaedic trauma surgeons
• patients who were independently mobile before their hip fracture
• patients without cognitive impairment (mini-mental score >6) and able to give informed consent
• patients without serious concomitant disease

Exclusion Criteria

• those not meeting the inclusion criteria
• patients who are not independently mobile outside the home
• unable to give informed consent
• serious concomitant disease with anaesthetic risk too great for Tsurgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Uncemented	Total hip arthroplasty	This group will receive an uncemented Corail stem and uncemented acetabular component (Depuy).
Cemented	Total hip arthroplasty	This group will receive a cemented Exeter stem and contemporary acetabular component (Stryker).

Primary Outcome Measures

Name	Time	Method
Hip specific function	1 year	This was measured using the Oxford hip score which ranges from 0 (worst score) to 48 (best score) points.

Secondary Outcome Measures

Name	Time	Method
Hip specific function	6, 12 and 72 months	Harris Hip Score which ranges from 0 (worst score) to 100 (best score) points.
Subjective patient hip pain	6, 12 and 72 months	Pain visual analogue scale from 1 (no pain) to 10 (maximum pain)
Operative time	At time of index surgery	Time from knife to skin to wound closure
Survival	Time of index surgery until final follow up (72 months), revision or death	Kaplan Meier assessment of implant survival
Generic health	6, 12 and 72 months	Euro Qol 5-dimension scale (3L) which ranges from -0.594 to 1, where 1 represents perfect health and 0 represents death. Negative values represent a state perceived as worse than death.
Mobility	6 months	Timed get up and go test
Intraoperative blood loss	At time of of surgery	Amount of blood lost during the index proceedure
Patient satisfaction	6, 12 and 72 months	Overall how satisfied are you with the results of your hip replacement surgery?" The response to each question was recorded using a five-point Likert scale: very satisfied, somewhat satisfied, neutral, somewhat dissatisfied, and very dissatisfied.
Complications	Time of surgery until one year following surgery	Rate of complications (intra / post operative)

Trial Locations

Locations (1)

NHS Lothian; 🇬🇧 Edinburgh, Edinburgh City, United Kingdom