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Uncemented Versus Cemented Total Hip Arthroplasty for Displaced Intracapsular Hip Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04372966
Recruitment Status : Terminated (The Chief Investigator (John Keating))
First Posted : May 4, 2020
Last Update Posted : May 4, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hip Fractures Device: Total hip arthroplasty Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomaised controlled trial
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Blinded
Primary Purpose: Treatment
Official Title: Prospective, Double Blind Randomised Controlled Trial Comparing the Uncemented (CORAIL, DePuy) Versus Cemented (Exeter) Total Knee Arthroplasty for Displaced Subcapital Hip Fractures
Actual Study Start Date : September 24, 2009
Actual Primary Completion Date : December 29, 2011
Actual Study Completion Date : December 29, 2016

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Total hip replacement




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


Secondary Outcome Measures :
  1. Hip specific function [ Time Frame: 6 and 72 months ]
    Oxford hip score which ranges from 0 (worst score) to 48 (best score) points.

  2. Hip specific function [ Time Frame: 6, 12 and 72 months ]
    Harris Hip Score which ranges from 0 (worst score) to 100 (best score) points.

  3. Generic health [ Time Frame: 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.

  4. Mobility [ Time Frame: 6 months ]
    Timed get up and go test

  5. Subjective patient hip pain [ Time Frame: 6, 12 and 72 months ]
    Pain visual analogue scale from 1 (no pain) to 10 (maximum pain)

  6. Operative time [ Time Frame: At time of index surgery ]
    Time from knife to skin to wound closure

  7. Intraoperative blood loss [ Time Frame: At time of of surgery ]
    Amount of blood lost during the index proceedure

  8. Patient satisfaction [ Time Frame: 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.

  9. Complications [ Time Frame: Time of surgery until one year following surgery ]
    Rate of complications (intra / post operative)

  10. Survival [ Time Frame: Time of index surgery until final follow up (72 months), revision or death ]
    Kaplan Meier assessment of implant survival



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04372966


Locations
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United Kingdom
NHS Lothian
Edinburgh, Edinburgh City, United Kingdom, EH16 4SA
Sponsors and Collaborators
NHS Lothian
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Responsible Party: NHS Lothian
ClinicalTrials.gov Identifier: NCT04372966    
Other Study ID Numbers: 06/S0501/80
First Posted: May 4, 2020    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This is not planned

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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
Additional relevant MeSH terms:
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Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries