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OsteoarthritisNCT01353326

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

A study testing Cormet and Conserve in people with Osteoarthritis, run by Ottawa Hospital Research Institute at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to compare the bone mineral density of patients who have undergone either cemented or cementless hip resurfacing. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Osteoarthritis
What is being tested?
Cormet and Conserve
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteCanada
Study dates
15 May 2009to Dec 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Ottawa General Hospital

    Ottawa, Ontario, K1H8L6

Other trials in Canada

About this study

Official title: Randomized Clinical Trial of a Cemented Versus Cementless Femoral Component for Metal on Metal Hip Resurfacing Assessing Bone Mineral Density

The purpose of this study is to compare the bone mineral density of patients who have undergone either cemented or cementless hip resurfacing.

Read the 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.

Conditions
Osteoarthritis
Being tested
Cormet, Conserve
Keywords
non-inflammatory degenerative joint disease, hip resurfacing, bone mineral density, cemented, cementless
Medical subject headings
Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CormetDevice

    Also called Cormet Hip Resurfacing System, Corin

    Cementless hip resurfacing system

  • ConserveDevice

    Also called Conserve Plus Total Resurfacing Hip System, Wright

    Cemented hip resurfacing system

Study groups in NCT01353326
Study groupRoleWhat they receive
Cementless Hip ResurfacingActive comparatorPatients randomized into the Cementless Hip Resurfacing Group will have their hip resurfaced with the cementless Cormet / Corin Hip Resurfacing System.
Receives: Device: Cormet
Cemented Hip ResurfacingActive comparatorPatients randomized into the Cemented Hip Resurfacing Group will have their hip resurfaced with the cemented Conserve Plus Total Resurfacing Hip System.
Receives: Device: Conserve

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 months

Secondary outcomes (5)

  1. 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.

    Measured: 24 months

  2. 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.

    Measured: 24 months

  3. 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.

    Measured: 24 months

  4. 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.

    Measured: 24 months

  5. 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.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2011 (estimated)
  2. Study start15 May 2009
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01353326
Sponsor's protocol ID
2008058-01H
Status last verified
Mar 2018
First submitted
30 Sep 2009
Last updated
2 Apr 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 26637673

Questions about this trial

What is this clinical trial studying?

A study testing Cormet and Conserve in people with Osteoarthritis, run by Ottawa Hospital Research Institute at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent change in BMD (g/cm2) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01353326, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2018.

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