A Comparison of an Advanced Metal Hip System to a Resurfacing Hip System

NCT00380549 | Completed

• 1 other identifier: OHREB 2005884-01H
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of the current study is to investigate if the CONSERVE® A-Class Total Hip with BFH technology will lead to lower blood ion levels in patients, as compared to patients in a recent study who received the CONSERVE® Plus Total Resurfacing Hip System, another metal-on-metal device. We are also comparing functional and radiographic (x-rays) outcomes between patients who receive the CONSERVE® A-Class Total Hip compared to those who have received the CONSERVE® Plus Total Resurfacing Hip System.

Conditions

Osteoarthritis

Keywords

osteoarthritis, hip replacement

Outcome Measures

Primary Outcomes (1)

• blood ion levels

  Assessment of Chromium and Cobalt ion levels in the blood

  2 years post-operative

Secondary Outcomes (1)

• functional outcomes radiographic outcomes complication rates

  2 years post-operatively

Study Arms (2)

CONSERVE® A-Class THA BFH

ACTIVE COMPARATOR

CONSERVE® A-Class Total Hip with BFH technology. Patients in this arm will undergo a unilateral total hip replacement with the CONSERVE® acetabular component and the CONSERVE® A-Class BFH femoral head. Blood ion levels will be collected and analyzed.

Diagnostic Test: Blood ion levels

CONSERVE® Plus Total Resurfacing Hip System

ACTIVE COMPARATOR

CONSERVE® Plus Total Resurfacing Hip System. Patients in this arm will undergo a unilateral total hip replacement with the CONSERVE® Plus Total Resurfacing Hip System. Blood ion levels will be collected and analyzed.

Diagnostic Test: Blood ion levels

Interventions

Blood ion levels DIAGNOSTIC_TEST

Blood ion levels or the levels of cobalt and chromium ions in the blood and urine will be analyzed.

CONSERVE® A-Class THA BFH; CONSERVE® Plus Total Resurfacing Hip System

Eligibility Criteria

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

You may qualify if:

• (1) Individuals undergoing unilateral total hip replacement with the CONSERVE® acetabular component and the CONSERVE® A-Class BFHä femoral head in combination with an uncemented femoral stem produced from the Ti-6A1-4V alloy (ASTM F-136) with or without titanium plasma coating.
• (2) Patients who are undergoing primary hip surgery for Noninflammatory Degenerative Joint Disease (NIDJD). Composite diagnoses of NIDJD include osteo/degenerative arthritis, traumatic arthritis, congenital hip dysplasia, and avascular necrosis.
• (3) Patients 18 years of age or older (skeletally mature). (4) 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 and for annual exams until the last patient entered into the study has achieved two years of follow-up.

You may not qualify if:

• (1) Patients with previous fusions, acute femoral neck fractures, above knee amputations, or significant arthritic changes to the knees.
• (2) Patients with evidence of active infection. (3) Patients with neurologic or musculoskeletal disease that may adversely affect gait or weight-bearing.
• (4) Patients who have previously undergone an ipsilateral hemi resurfacing, total resurfacing, total bipolar, unipolar or total hip replacement device.
• (5) Patients with neuropathic joints. (6) Patients with severe documented psychiatric disease. (7) Patients requiring structural bone grafts. (8) Patients with a documented allergy to cobalt chromium molybdenum. (9) Patients with an ipsilateral girdlestone. (10) Patients with sickle cell disease. (11) Patients with renal failure as defined by serum creatinine level greater than 180 Fmol/L.
• (12) Patients who otherwise meet the study criteria, but refuse to consent in writing to participate in the study.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Stryker Trauma and Extremities: collaborator

Study Sites (1)

Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

Related Publications (1)

• Beaule PE, Kim PR, Hamdi A, Fazekas A. A prospective metal ion study of large-head metal-on-metal bearing: a matched-pair analysis of hip resurfacing versus total hip replacement. Orthop Clin North Am. 2011 Apr;42(2):251-7, ix. doi: 10.1016/j.ocl.2011.01.005.

  PMID: 21435499 RESULT

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Paul Kim, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2006
• First Posted: September 26, 2006
• Study Start: June 1, 2006
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: March 10, 2020

Record last verified: 2020-03

Locations

CA (1)