Total Hip ArthroplastyNCT01558752
A Clinical Trial of a Metal on Poly Component Versus CORAIL Stem: A Bone Mineral Density Study
A study testing Total hip replacement with titanium shell and CORAIL stem and Total hip replacement with Modular Titanium Femoral Stem in people with Total Hip Arthroplasty, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
The main goal is to prospectively evaluate bone mineral density adjacent to the femoral component and femoral bone remodeling of two different designs: CORAIL impaction broach titanium stem compared to a modular titanium femoral stem (Tri-lock). Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Total Hip Arthroplasty
- What is being tested?
- Total hip replacement with titanium shell and CORAIL stem and Total hip replacement with Modular Titanium Femoral Stem
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2010to 20 Nov 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are undergoing primary hip surgery for osteo/degenerative arthritis (does not include traumatic arthritis, congenital hip dysplasia, or avascular necrosis).
- Patients who are skeletally mature, as determined by Risser sign or at least 18 years of age
- Patients under 75 years of age
- Patients for whom there is a reasonable expectation that they will be available for each examination scheduled over a two year post-operative follow-up period.
Who cannot join
- Patients with previous fusions, acute femoral neck fractures and above knee amputations.
- Patients with evidence of active local infection
- Patients with neurologic or musculoskeletal disease that may adversely affect gait or weight-bearing.
- Patients who have previously undergone an ipsilateral hemi resurfacing, total resurfacing, total bipolar, unipolar or total hip replacement device, or any prior hip surgery or retained internal fixation.
- Patients who are anticipated to require contralateral hip surgery in the next year
- Patients with known disorders of bone metabolism, systemic inflammatory disorders, and use of drug medications, including oral steroids, HRT, Tamoxifen, calcium, or vitamin D in the past year, and any past bisphosphonate therapy.
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- Patients with a Body Mass Index (BMI) > 35
- Patients with neuropathic joints
- Patients with severe documented psychiatric disease
- Patients requiring structural bone grafts
- Patients with an ipsilateral girdlestone
- Patients with sickle cell disease
- Patients with major acetabular bone stock deficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Clinical Trial of a Modular Cementless Acetabular Metal on Poly Component Versus a Monoblock Cementless Titanium Shell With Ceramic on Ceramic Bearing and CORAIL Stem: A Bone Mineral Density Study
The main goal is to prospectively evaluate bone mineral density adjacent to the femoral component and femoral bone remodeling of two different designs: CORAIL impaction broach titanium stem compared to a modular titanium femoral stem (Tri-lock). Patients will be randomized to one of the two treatment groups prior to surgery. Each patient will be evaluated at their regularly scheduled 10-14 days, 3, 6, 12 and 24 month visits following surgery. Patients will be asked to have bilateral DEXA bone mineral density tests (10-14 days post-surgery, and 6, 12 and 24 months post-operatively). Urine and serum samples (measures of bone turnover) will be collected at 3, 6 and 12 months post-operatively after an overnight fast. Patient reported questionnaires will be completed preoperatively and at the 3, 6, 12, and 24 month visits.
Read the detailed description
The main goal is to prospectively evaluate bone mineral density adjacent to the femoral component and femoral bone remodeling of two different designs: CORAIL impaction broach titanium stem compared to a modular titanium femoral stem (Tri-lock). The investigators expect the CORAIL femoral stem group to show significantly less bone loss on the femoral side as compared to the Tri-lock group. The primary outcome is percent change in bone mineral density (BMD) (g/cm2) from baseline (10-14 days post-op) to the two year post-operative interval, as measured radiographically in zones 1 and 7.
Patients will be randomized to one of the two treatment groups prior to surgery. Each patient will be evaluated at their regularly scheduled 10-14 days, 3, 6, 12 and 24 month visits following surgery.
Bilateral DXA bone mineral density tests will be performed at 10-14 days following surgery (baseline assessment) and at 6, 12, and 24 months post-operatively.
Urine and serum samples (measures of bone turnover) will be collected at 3, 6 and 12 months post-operatively after an overnight fast.
The Harris Hip Score will be completed at each post-operative visit except the immediate (10-14 days), when risk of dislocation precludes a determination of range of motion. At the 3, 6, 12 and 24 month post-operative visits, the patient will complete the SF-36 Item Health Survey, WOMAC and UCLA activity scale.
- Conditions
- Total Hip Arthroplasty
- Being tested
- Total hip replacement with titanium shell and CORAIL stem, Total hip replacement with Modular Titanium Femoral Stem
- Keywords
- Total Hip Replacement, Bone Mineral Density, Stem, Dual-energy x-ray absorptiometry, DXA-RFA, Corail, Tri-Lock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total hip replacement with titanium shell and CORAIL stemDevice
Patients that are randomized into Group 1 will receive a total hip replacement with the following components: CORAIL (impaction broach) titanium stem and a monoblock cup with ceramic on ceramic bearing (DELTA motion).
Total hip replacement with Modular Titanium Femoral StemDevice
Patients that are randomized into Group 2 will receive a total hip replacement with the following components: the Trilock-Pinnacle system (titanium stem and titanium cup with polyethylene insert).
| Study group | Role | What they receive |
|---|---|---|
| Titanium Shell with CORAIL stem | Experimental | Patients in Group 1 will receive a total hip replacement with titanium shell and CORAIL stem. Receives: Device: Total hip replacement with titanium shell and CORAIL stem |
| Modular Titanium Femoral Stem (Tri-Lock) | Active comparator | Patients in Group 2 will receive a total hip replacement with Modular Titanium Femoral Stem (Tri-lock). Receives: Device: Total hip replacement with Modular Titanium Femoral Stem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bone Mineral Density
To prospectively evaluate bone mineral density adjacent to the femoral component and femoral bone remodeling for the 2 groups. Bone mineral density was assessed using high-sensitivity dual x-ray absorptiometry region-free analysis (DXA-RFA). Mean number of pixels with change with significant BMD decrease.
Measured: 2 Years Post-operative
Secondary outcomes (6)
Comparison of Bone Turnover Markers Between Groups
Biochemical markers of bone turnover will be assessed from morning-fasting serum samples and compared from baseline to 2-years post-operative.
Measured: 2 Years post-operative
Implant Migration
Stem and cup migration will be assessed using radiographic images at baseline and 2-years post-operative.
Measured: 2 years post-operative
Change in Modified Harris Hip Score
The change from baseline to 2-years post-operative on the Modified Harris Hip Score (mHHS). The mHHS assesses a patient's functional outcome and pain. The maximum score is 100 and the lowest is 0. A higher score is indicative of better outcomes and lower pain levels.
Measured: 2 Years post-operative
Change in SF-36 Score
The change from baseline to 2-years post-operative on the SF-36 score: a quality of-life measure. The score consists of 36 questions separated into 8 concepts. These outcomes will be grouped as physical component summary and mental component summary. The norm data is 0-100. The health related quality of life is increases as the scores are increased. The average score is 50.
Measured: 2 Years post-operative
Change in WOMAC Questionnaire
The change from baseline to 2-years post-operative on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The WOMAC score consists of 24 items, separated into 3 subscales. Each question is scored on a scale of 0 to 4, with a possible score range of 0-20 for pain, 0-8 for stiffness, and 0-68 for physical function. The scores of each subscale are summed to give a total score. Higher scores are indicative of worse pain, stiffness and functional limitations.
Measured: 2 Years post-operative
Change in UCLA Activity Scale
The change from baseline to 2-years post-operative on the UCLA Activity score. The UCLA activity scale is a 10 point scale evaluating a patients activity level. The possible score range is from 0-10. A low value is indicative of sedentary or inactivity, whereas a high score is indicative of high levels of activity.
Measured: 2 Years post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2012 (estimated)
- Study startApr 2010
- Primary completion31 Jul 2019
- Study completion20 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Factorial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Responsible party
- Sponsor
- Investigators
- Paul E Beaulé, MD, FRCSC, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01558752
- Sponsor's protocol ID
- 2010913-01H
- Status last verified
- Nov 2020
- First submitted
- 16 Mar 2012
- Last updated
- 19 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Slullitel PA, Mahatma MM, Farzi M, Grammatopoulos G, Wilkinson JM, Beaule PE. Influence of Femoral Component Design on Proximal Femoral Bone Mass After Total Hip Replacement: A Randomized Controlled Trial. J Bone Joint Surg Am. 2021 Jan 6;103(1):74-83. doi: 10.2106/JBJS.20.00351.
PubMed 33079901Fischman D, Mahatma MM, Slullitel P, Farzi M, Grammatopoulos G, Poitras S, Wilkinson JM, Beaule PE. Does a Monoblock Acetabular Component With a Ceramic Liner Cause More Pelvic Bone Loss Than a Conventional Modular Cementless Acetabular Component? A 2-Year Randomized Clinical Trial. J Arthroplasty. 2022 Jan;37(1):75-82. doi: 10.1016/j.arth.2021.08.033. Epub 2021 Sep 4.
PubMed 34649747
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of a Modular Cementless Acetabular Metal on Poly Component Versus a Monoblock Cementless Titanium Shell With Ceramic on Ceramic Bearing and CORAIL Stem: A Bone Mineral Density Study
- ClinicalTrials.gov ID
- NCT01558752
- Acronym / sponsor ID
- 2010913-01H
- Conditions
- Total Hip Arthroplasty
- Keywords
- Total Hip Replacement, Bone Mineral Density, Stem, Dual-energy x-ray absorptiometry, DXA-RFA, Corail, Tri-Lock
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- Apr 2010 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 20 Nov 2020 (actual)
- First posted
- 20 Mar 2012 (estimated)
- Results
- Posted 19 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main goal is to prospectively evaluate bone mineral density adjacent to the femoral component and femoral bone remodeling of two different designs: CORAIL impaction broach titanium stem compared to a modular titanium femoral stem (Tri-lock). Patients will be randomized to one of the two treatment groups prior to surgery. Each patient will be evaluated at their regularly scheduled 10-14 days, 3, 6, 12 and 24 month visits following surgery. Patients will be asked to have bilateral DEXA bone mineral density tests (10-14 days post-surgery, and 6, 12 and 24 months post-operatively). Urine and serum samples (measures of bone turnover) will be collected at 3, 6 and 12 months post-operatively after an overnight fast. Patient reported questionnaires will be completed preoperatively and at the 3, 6, 12, and 24 month visits.
Detailed description
The main goal is to prospectively evaluate bone mineral density adjacent to the femoral component and femoral bone remodeling of two different designs: CORAIL impaction broach titanium stem compared to a modular titanium femoral stem (Tri-lock). The investigators expect the CORAIL femoral stem group to show significantly less bone loss on the femoral side as compared to the Tri-lock group. The primary outcome is percent change in bone mineral density (BMD) (g/cm2) from baseline (10-14 days post-op) to the two year post-operative interval, as measured radiographically in zones 1 and 7.
Patients will be randomized to one of the two treatment groups prior to surgery. Each patient will be evaluated at their regularly scheduled 10-14 days, 3, 6, 12 and 24 month visits following surgery.
Bilateral DXA bone mineral density tests will be performed at 10-14 days following surgery (baseline assessment) and at 6, 12, and 24 months post-operatively.
Urine and serum samples (measures of bone turnover) will be collected at 3, 6 and 12 months post-operatively after an overnight fast.
The Harris Hip Score will be completed at each post-operative visit except the immediate (10-14 days), when risk of dislocation precludes a determination of range of motion. At the 3, 6, 12 and 24 month post-operative visits, the patient will complete the SF-36 Item Health Survey, WOMAC and UCLA activity scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Titanium Shell with CORAIL stem | Experimental | Device: Total hip replacement with titanium shell and CORAIL stemPatients in Group 1 will receive a total hip replacement with titanium shell and CORAIL stem. |
| Modular Titanium Femoral Stem (Tri-Lock) | Active comparator | Device: Total hip replacement with Modular Titanium Femoral StemPatients in Group 2 will receive a total hip replacement with Modular Titanium Femoral Stem (Tri-lock). |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who are undergoing primary hip surgery for osteo/degenerative arthritis (does not include traumatic arthritis, congenital hip dysplasia, or avascular necrosis).
- Patients who are skeletally mature, as determined by Risser sign or at least 18 years of age
- Patients under 75 years of age
- Patients for whom there is a reasonable expectation that they will be available for each examination scheduled over a two year post-operative follow-up period.
Key exclusion criteria (13 listed)
- Patients with previous fusions, acute femoral neck fractures and above knee amputations.
- Patients with evidence of active local infection
- Patients with neurologic or musculoskeletal disease that may adversely affect gait or weight-bearing.
- Patients who have previously undergone an ipsilateral hemi resurfacing, total resurfacing, total bipolar, unipolar or total hip replacement device, or any prior hip surgery or retained internal fixation.
- Patients who are anticipated to require contralateral hip surgery in the next year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total hip replacement with titanium shell and CORAIL stemPatients that are randomized into Group 1 will receive a total hip replacement with the following components: CORAIL (impaction broach) titanium stem and a monoblock cup with ceramic on ceramic bearing (DELTA motion). | Device | Titanium Shell with CORAIL stem |
| Total hip replacement with Modular Titanium Femoral StemPatients that are randomized into Group 2 will receive a total hip replacement with the following components: the Trilock-Pinnacle system (titanium stem and titanium cup with polyethylene insert). | Device | Modular Titanium Femoral Stem (Tri-Lock) |
Primary outcome
Change in Bone Mineral Density
Time frame: 2 Years Post-operative
To prospectively evaluate bone mineral density adjacent to the femoral component and femoral bone remodeling for the 2 groups. Bone mineral density was assessed using high-sensitivity dual x-ray absorptiometry region-free analysis (DXA-RFA). Mean number of pixels with change with significant BMD decrease.
6 secondary outcomes
Comparison of Bone Turnover Markers Between Groups
Time frame: 2 Years post-operative
Implant Migration
Time frame: 2 years post-operative
Change in Modified Harris Hip Score
Time frame: 2 Years post-operative
Change in SF-36 Score
Time frame: 2 Years post-operative
Change in WOMAC Questionnaire
Time frame: 2 Years post-operative
Change in UCLA Activity Scale
Time frame: 2 Years post-operatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33079901Slullitel PA, Mahatma MM, Farzi M, Grammatopoulos G, Wilkinson JM, Beaule PE. Influence of Femoral Component Design on Proximal Femoral Bone Mass After Total Hip Replacement: A Randomized Controlled Trial. J Bone Joint Surg Am. 2021 Jan 6;103(1):74-83. doi: 10.2106/JBJS.20.00351.
- Derived from this study: PubMed 34649747Fischman D, Mahatma MM, Slullitel P, Farzi M, Grammatopoulos G, Poitras S, Wilkinson JM, Beaule PE. Does a Monoblock Acetabular Component With a Ceramic Liner Cause More Pelvic Bone Loss Than a Conventional Modular Cementless Acetabular Component? A 2-Year Randomized Clinical Trial. J Arthroplasty. 2022 Jan;37(1):75-82. doi: 10.1016/j.arth.2021.08.033. Epub 2021 Sep 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul E Beaulé, MD, FRCSC principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total hip replacement with titanium shell and CORAIL stem and Total hip replacement with Modular Titanium Femoral Stem in people with Total Hip Arthroplasty, 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 4 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 19 Dec 2020. 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?
Yes. Results are posted in the registry (first posted 19 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Bone Mineral Density (time frame: 2 Years Post-operative). 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 NCT01558752, which also lists 2 linked publications.
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 19 Dec 2020.