Uncemented Versus Cemented Total Hip Arthroplasty for Displaced Intracapsular Hip Fractures

Prospective, Double Blind Randomised Controlled Trial Comparing the Uncemented (CORAIL, DePuy) Versus Cemented (Exeter) Total Knee Arthroplasty for Displaced Subcapital Hip Fractures

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.

Study Overview

• Status: Terminated
• Conditions: Hip Fractures
• Intervention / Treatment: Device: Total hip arthroplasty

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Edinburgh City
    • Edinburgh, Edinburgh City, United Kingdom, EH16 4SA
      • NHS Lothian

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cemented; This group will receive a cemented Exeter stem and contemporary acetabular component (Stryker).	Device: Total hip arthroplasty; Corail Total hip arthroplasty system, Depuy. Exeter and Contemporary acetabular components, Stryker.; Other Names: Total hip replacement
Active Comparator: Uncemented; This group will receive an uncemented Corail stem and uncemented acetabular component (Depuy).	Device: Total hip arthroplasty; Corail Total hip arthroplasty system, Depuy. Exeter and Contemporary acetabular components, Stryker.; Other Names: Total hip replacement

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hip specific function	Oxford hip score which ranges from 0 (worst score) to 48 (best score) points.	6 and 72 months
Hip specific function	Harris Hip Score which ranges from 0 (worst score) to 100 (best score) points.	6, 12 and 72 months
Generic health	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.	6, 12 and 72 months
Mobility	Timed get up and go test	6 months
Subjective patient hip pain	Pain visual analogue scale from 1 (no pain) to 10 (maximum pain)	6, 12 and 72 months
Operative time	Time from knife to skin to wound closure	At time of index surgery
Intraoperative blood loss	Amount of blood lost during the index proceedure	At time of of surgery
Patient satisfaction	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.	6, 12 and 72 months
Complications	Rate of complications (intra / post operative)	Time of surgery until one year following surgery
Survival	Kaplan Meier assessment of implant survival	Time of index surgery until final follow up (72 months), revision or death

Collaborators and Investigators

• Sponsor: NHS Lothian

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2009
• Primary Completion (Actual): December 29, 2011
• Study Completion (Actual): December 29, 2016

Study Registration Dates

• First Submitted: April 27, 2020
• First Submitted That Met QC Criteria: April 29, 2020
• First Posted (Actual): May 4, 2020

Study Record Updates

• Last Update Posted (Actual): May 4, 2020
• Last Update Submitted That Met QC Criteria: April 29, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: 06/S0501/80

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is not planned

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No