A Clinical Trial of a Metal on Poly Component Versus CORAIL Stem: A Bone Mineral Density Study

NCT01558752 | Completed Results DMC

• 1 other identifier: 2010913-01H
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Hip Arthroplasty

Keywords

Total Hip Replacement; Bone Mineral Density; Stem; Dual-energy x-ray absorptiometry; DXA-RFA; Corail; Tri-Lock

Outcome Measures

Primary Outcomes (1)

• 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.

  2 Years Post-operative

Secondary Outcomes (6)

• Comparison of Bone Turnover Markers Between Groups

  2 Years post-operative

• Implant Migration

  2 years post-operative

• Change in Modified Harris Hip Score

  2 Years post-operative

• Change in SF-36 Score

  2 Years post-operative

• Change in WOMAC Questionnaire

  2 Years post-operative

Study Arms (2)

Titanium Shell with CORAIL stem

EXPERIMENTAL

Patients in Group 1 will receive a total hip replacement with titanium shell and CORAIL stem.

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).

Device: Total hip replacement with Modular Titanium Femoral Stem

Interventions

Total hip replacement with titanium shell and CORAIL stem DEVICE

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).

Titanium Shell with CORAIL stem

Total hip replacement with Modular Titanium Femoral Stem DEVICE

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).

Modular Titanium Femoral Stem (Tri-Lock)

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Johnson & Johnson: collaborator

Study Sites (1)

The Ottawa Hospital - General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Related Publications (2)

• 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.

  PMID: 33079901 RESULT

• 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.

  PMID: 34649747 DERIVED

MeSH Terms

Interventions

Arthroplasty, Replacement, Hip

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Results Point of Contact

• Title: Dr Paul Beaule
• Organization: The Ottawa Hospital Research Institute

pbeaule@toh.ca

613-737-8899

Study Officials

• Paul E Beaulé, MD, FRCSC

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2012
• First Posted: March 20, 2012
• Study Start: April 1, 2010
• Primary Completion: July 31, 2019
• Study Completion: November 20, 2020
• Last Updated: December 19, 2020
• Results First Posted: December 19, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)