Clinical trial NCT01558752: A Clinical Trial of a Metal on Poly Component Versus CORAIL Stem: A Bone Mineral Density 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Hip Arthroplasty
Keywords: Total Hip Replacement
Bone Mineral Density
Stem
Dual-energy x-ray absorptiometry
DXA-RFA
Corail
Tri-Lock
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson
First posted: 2012-03-20
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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). 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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

Primary outcomes:
measure: Change in Bone Mineral Density
timeFrame: 2 Years Post-operative
Secondary outcomes:
measure: Comparison of Bone Turnover Markers Between Groups
timeFrame: 2 Years post-operative
measure: Implant Migration
timeFrame: 2 years post-operative
measure: Change in Modified Harris Hip Score
timeFrame: 2 Years post-operative
measure: Change in SF-36 Score
timeFrame: 2 Years post-operative
measure: Change in WOMAC Questionnaire
timeFrame: 2 Years post-operative
measure: Change in UCLA Activity Scale
timeFrame: 2 Years post-operatively
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital - General Campus
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Paul E Beaulé, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Fischman 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.