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Bone Mineral Density (BMD) in Cemented Versus Cementless Hip Resurfacing

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cormet
Conserve
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring non-inflammatory degenerative joint disease, hip resurfacing, bone mineral density, cemented, cementless

Eligibility Criteria

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

Inclusion Criteria:

  • Must be undergoing primary hip surgery for Noninflammatory Degenerative Joint Disease
  • must be skeletally mature, as determined by Risser sign or reaching 18 years of age
  • Is reasonable expectation that patient will remain available for all FU's scheduled over course of 5 years

Exclusion Criteria:

  • Previous fusions, acute femoral neck fractures, and above knee amputations
  • evidence of active local infection
  • neurologic or musculoskeletal disease that may adversely affect gait or weight bearing
  • having previously undergone ipsilateral hemi resurfacing, total resurfacing, total bipolar, unipolar or total hip replacement device
  • BMI >35
  • neuropathic joints
  • severe documented psychiatric disease
  • patients requiring structural bone grafts
  • documented allergy to cobalt chromium molybdenum
  • ipsilateral girdlestone
  • sickle cell disease
  • significant femoral head or neck deformity, or significant acetabular wall deficiency
  • patients with renal failure, defined as serum creatinine greater that 180 µmol/L

Sites / Locations

  • Ottawa General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cementless Hip Resurfacing

Cemented Hip Resurfacing

Arm Description

Patients randomized into the Cementless Hip Resurfacing Group will have their hip resurfaced with the cementless Cormet / Corin Hip Resurfacing System.

Patients randomized into the Cemented Hip Resurfacing Group will have their hip resurfaced with the cemented Conserve Plus Total Resurfacing Hip System.

Outcomes

Primary Outcome Measures

Percent change in BMD (g/cm2)
The primary outcome is percent change in BMD (g/cm2) from baseline to the 1-year post-operative interval, as measured radiographically in zone L1. Analysis of periprosthetic BMD will be achieved using 6 zones of the femoral neck, which have been used in previous studies

Secondary Outcome Measures

Implant Migration
Radiographs will be taken preoperatively and until 24 months post-operatively to assess for any cup loosening. Implant migration, both vertical and horizontal, will be measured on serial radiographs using the computer-assisted Ein Bild Röentgen Analyse (EBRA) software for cup migration.
Harris Hip Score (HHS) Questionnaire
The Harris Hip Score (HHS) is intended to evaluate various hip disabilities and methods of treatment. The HHS is comprised of 4 domains: pain, function, absence of deformity, and range of motion. The score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points). The total score is calculated by summing the scores for the 4 domains. The higher the HHS, the less dysfunction.
WOMAC Questionnaire to assess functionality
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) consists of 24 items divided into 3 subscales: Pain (5 items), stiffness (2 items), and function (17 items). This questionnaire is self-administered using the 5-point Likert-type scale (none, mild, moderate, severe, extreme). These correspond to an ordinal scale of 0-4. The scores are summed (0-100), where higher scores are indicative of worse pain, stiffness, and functional limitations.
RAND-36 Item Health Survey
The RAND-36 Item Health Survey assesses patient health-related quality of life and consists of 8 health concepts: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (3 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). It also includes a single item that provides an indication of perceived change in health. Each item is scored on a 0 to 100 range, with a high score defined as a more favourable health state. Scores are averaged together to create the 8 scale scores.
UCLA Activity Score
The UCLA Activity Score will be used to assess the patients highest-rated activity, regardless of the frequency or intensity of participation. Patients are asked to select 1 out of 10 possible answers that best fit their current activity level (0-10). Low values are indicative of a sedentary lifestyle, while higher values are indicative of high impact activities.

Full Information

First Posted
September 30, 2009
Last Updated
March 29, 2018
Sponsor
Ottawa Hospital Research Institute
Collaborators
Corin
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1. Study Identification

Unique Protocol Identification Number
NCT01353326
Brief Title
Bone Mineral Density (BMD) in Cemented Versus Cementless Hip Resurfacing
Official Title
Randomized Clinical Trial of a Cemented Versus Cementless Femoral Component for Metal on Metal Hip Resurfacing Assessing Bone Mineral Density
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
May 15, 2009 (Actual)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
Collaborators
Corin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare the bone mineral density of patients who have undergone either cemented or cementless hip resurfacing.
Detailed Description
Recent research is inconclusive regarding the degree to which the density or strength of the bone around the hip implant is preserved following a hip resurfacing system. Certainly, there are many factors which contribute to the preservation of bone mineral density - we are studying the role of cement. More specifically, we are trying to compare outcomes between patients who receive the cementless Cormet Hip Resurfacing System to those who receive the cemented CONSERVE® Plus Total Resurfacing Hip System. Therefore, the primary purpose of the current study is to compare the bone mineral density between the cementless and cemented hip resurfacing systems. We are also comparing patients who receive these two different hip systems in terms of their x-rays and how they are managing with their hip.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
non-inflammatory degenerative joint disease, hip resurfacing, bone mineral density, cemented, cementless

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cementless Hip Resurfacing
Arm Type
Active Comparator
Arm Description
Patients randomized into the Cementless Hip Resurfacing Group will have their hip resurfaced with the cementless Cormet / Corin Hip Resurfacing System.
Arm Title
Cemented Hip Resurfacing
Arm Type
Active Comparator
Arm Description
Patients randomized into the Cemented Hip Resurfacing Group will have their hip resurfaced with the cemented Conserve Plus Total Resurfacing Hip System.
Intervention Type
Device
Intervention Name(s)
Cormet
Other Intervention Name(s)
Cormet Hip Resurfacing System, Corin
Intervention Description
Cementless hip resurfacing system
Intervention Type
Device
Intervention Name(s)
Conserve
Other Intervention Name(s)
Conserve Plus Total Resurfacing Hip System, Wright
Intervention Description
Cemented hip resurfacing system
Primary Outcome Measure Information:
Title
Percent change in BMD (g/cm2)
Description
The primary outcome is percent change in BMD (g/cm2) from baseline to the 1-year post-operative interval, as measured radiographically in zone L1. Analysis of periprosthetic BMD will be achieved using 6 zones of the femoral neck, which have been used in previous studies
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Implant Migration
Description
Radiographs will be taken preoperatively and until 24 months post-operatively to assess for any cup loosening. Implant migration, both vertical and horizontal, will be measured on serial radiographs using the computer-assisted Ein Bild Röentgen Analyse (EBRA) software for cup migration.
Time Frame
24 months
Title
Harris Hip Score (HHS) Questionnaire
Description
The Harris Hip Score (HHS) is intended to evaluate various hip disabilities and methods of treatment. The HHS is comprised of 4 domains: pain, function, absence of deformity, and range of motion. The score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points). The total score is calculated by summing the scores for the 4 domains. The higher the HHS, the less dysfunction.
Time Frame
24 months
Title
WOMAC Questionnaire to assess functionality
Description
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) consists of 24 items divided into 3 subscales: Pain (5 items), stiffness (2 items), and function (17 items). This questionnaire is self-administered using the 5-point Likert-type scale (none, mild, moderate, severe, extreme). These correspond to an ordinal scale of 0-4. The scores are summed (0-100), where higher scores are indicative of worse pain, stiffness, and functional limitations.
Time Frame
24 months
Title
RAND-36 Item Health Survey
Description
The RAND-36 Item Health Survey assesses patient health-related quality of life and consists of 8 health concepts: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (3 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). It also includes a single item that provides an indication of perceived change in health. Each item is scored on a 0 to 100 range, with a high score defined as a more favourable health state. Scores are averaged together to create the 8 scale scores.
Time Frame
24 months
Title
UCLA Activity Score
Description
The UCLA Activity Score will be used to assess the patients highest-rated activity, regardless of the frequency or intensity of participation. Patients are asked to select 1 out of 10 possible answers that best fit their current activity level (0-10). Low values are indicative of a sedentary lifestyle, while higher values are indicative of high impact activities.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must be undergoing primary hip surgery for Noninflammatory Degenerative Joint Disease must be skeletally mature, as determined by Risser sign or reaching 18 years of age Is reasonable expectation that patient will remain available for all FU's scheduled over course of 5 years Exclusion Criteria: Previous fusions, acute femoral neck fractures, and above knee amputations evidence of active local infection neurologic or musculoskeletal disease that may adversely affect gait or weight bearing having previously undergone ipsilateral hemi resurfacing, total resurfacing, total bipolar, unipolar or total hip replacement device BMI >35 neuropathic joints severe documented psychiatric disease patients requiring structural bone grafts documented allergy to cobalt chromium molybdenum ipsilateral girdlestone sickle cell disease significant femoral head or neck deformity, or significant acetabular wall deficiency patients with renal failure, defined as serum creatinine greater that 180 µmol/L
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Paul Beaule, MD, FRCSC
Organizational Affiliation
Ottawa Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ottawa General Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H8L6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
26637673
Citation
Tice A, Kim P, Dinh L, Ryu JJ, Beaule PE. A randomised controlled trial of cemented and cementless femoral components for metal-on-metal hip resurfacing: a bone mineral density study. Bone Joint J. 2015 Dec;97-B(12):1608-14. doi: 10.1302/0301-620X.97B12.36110.
Results Reference
result

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Bone Mineral Density (BMD) in Cemented Versus Cementless Hip Resurfacing

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