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Uncemented Versus Cemented Total Hip Arthroplasty for Displaced Intracapsular Hip Fractures

Primary Purpose

Hip Fractures

Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Total hip arthroplasty
Sponsored by
NHS Lothian
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NHS Lothian

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cemented

Uncemented

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Hip specific function
Oxford hip score which ranges from 0 (worst score) to 48 (best score) points.
Hip specific function
Harris Hip Score which ranges from 0 (worst score) to 100 (best score) points.
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.
Mobility
Timed get up and go test
Subjective patient hip pain
Pain visual analogue scale from 1 (no pain) to 10 (maximum pain)
Operative time
Time from knife to skin to wound closure
Intraoperative blood loss
Amount of blood lost during the index proceedure
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.
Complications
Rate of complications (intra / post operative)
Survival
Kaplan Meier assessment of implant survival

Full Information

First Posted
April 27, 2020
Last Updated
April 29, 2020
Sponsor
NHS Lothian
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1. Study Identification

Unique Protocol Identification Number
NCT04372966
Brief Title
Uncemented Versus Cemented Total Hip Arthroplasty for Displaced Intracapsular Hip Fractures
Official Title
Prospective, Double Blind Randomised Controlled Trial Comparing the Uncemented (CORAIL, DePuy) Versus Cemented (Exeter) Total Knee Arthroplasty for Displaced Subcapital Hip Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Terminated
Why Stopped
The Chief Investigator (John Keating)
Study Start Date
September 24, 2009 (Actual)
Primary Completion Date
December 29, 2011 (Actual)
Study Completion Date
December 29, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NHS Lothian

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomaised controlled trial
Masking
ParticipantOutcomes Assessor
Masking Description
Blinded
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cemented
Arm Type
Active Comparator
Arm Description
This group will receive a cemented Exeter stem and contemporary acetabular component (Stryker).
Arm Title
Uncemented
Arm Type
Active Comparator
Arm Description
This group will receive an uncemented Corail stem and uncemented acetabular component (Depuy).
Intervention Type
Device
Intervention Name(s)
Total hip arthroplasty
Other Intervention Name(s)
Total hip replacement
Intervention Description
Corail Total hip arthroplasty system, Depuy. Exeter and Contemporary acetabular components, Stryker.
Primary Outcome Measure Information:
Title
Hip specific function
Description
This was measured using the Oxford hip score which ranges from 0 (worst score) to 48 (best score) points.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Hip specific function
Description
Oxford hip score which ranges from 0 (worst score) to 48 (best score) points.
Time Frame
6 and 72 months
Title
Hip specific function
Description
Harris Hip Score which ranges from 0 (worst score) to 100 (best score) points.
Time Frame
6, 12 and 72 months
Title
Generic health
Description
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.
Time Frame
6, 12 and 72 months
Title
Mobility
Description
Timed get up and go test
Time Frame
6 months
Title
Subjective patient hip pain
Description
Pain visual analogue scale from 1 (no pain) to 10 (maximum pain)
Time Frame
6, 12 and 72 months
Title
Operative time
Description
Time from knife to skin to wound closure
Time Frame
At time of index surgery
Title
Intraoperative blood loss
Description
Amount of blood lost during the index proceedure
Time Frame
At time of of surgery
Title
Patient satisfaction
Description
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.
Time Frame
6, 12 and 72 months
Title
Complications
Description
Rate of complications (intra / post operative)
Time Frame
Time of surgery until one year following surgery
Title
Survival
Description
Kaplan Meier assessment of implant survival
Time Frame
Time of index surgery until final follow up (72 months), revision or death

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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 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
Facility Information:
Facility Name
NHS Lothian
City
Edinburgh
State/Province
Edinburgh City
ZIP/Postal Code
EH16 4SA
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This is not planned

Learn more about this trial

Uncemented Versus Cemented Total Hip Arthroplasty for Displaced Intracapsular Hip Fractures

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