Uncemented Versus Cemented Total Hip Arthroplasty for Displaced Intracapsular Hip Fractures

NCT ID: NCT04372966

Last Updated: 2020-05-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-24
• Study Completion Date: 2016-12-29

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.

Conditions

Hip Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cemented

This group will receive a cemented Exeter stem and contemporary acetabular component (Stryker).

Group Type: ACTIVE_COMPARATOR

Total hip arthroplasty

Intervention Type: DEVICE

Corail Total hip arthroplasty system, Depuy. Exeter and Contemporary acetabular components, Stryker.

Uncemented

This group will receive an uncemented Corail stem and uncemented acetabular component (Depuy).

Group Type: ACTIVE_COMPARATOR

Total hip arthroplasty

Intervention Type: DEVICE

Corail Total hip arthroplasty system, Depuy. Exeter and Contemporary acetabular components, Stryker.

Interventions

Total hip arthroplasty

Corail Total hip arthroplasty system, Depuy. Exeter and Contemporary acetabular components, Stryker.

Intervention Type: DEVICE

Other Intervention Names

Total hip replacement

Eligibility Criteria

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

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NHS Lothian

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

NHS Lothian

Edinburgh, Edinburgh City, United Kingdom

Countries

United Kingdom

Other Identifiers

06/S0501/80

Identifier Type: -

Identifier Source: org_study_id