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

Primary Purpose

Osteoarthritis

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Blood ion levels

About this trial

This is an interventional screening trial for Osteoarthritis focused on measuring osteoarthritis, hip replacement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

(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.
(5) Patients who agree to participate and sign the Informed Consent Form. (6) Patients who do not meet any of the exclusion criteria.

Exclusion Criteria:

(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.

Sites / Locations

Ottawa Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

CONSERVE® A-Class THA BFH

CONSERVE® Plus Total Resurfacing Hip System

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

blood ion levels

Assessment of Chromium and Cobalt ion levels in the blood

Secondary Outcome Measures

functional outcomes radiographic outcomes complication rates

Assessment of clinical efficiency of the implant by validated questionannires and radiographic analysis

Full Information

NCT ID

NCT00380549

First Posted

September 23, 2006

Last Updated

March 6, 2020

Sponsor

Ottawa Hospital Research Institute

Collaborators

Stryker Trauma GmbH

1. Study Identification

Unique Protocol Identification Number

NCT00380549

Brief Title

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

Official Title

A Prospective Case Series (Pilot Study) Comparing Ion Levels and Clinical Outcomes of the CONSERVE® A-Class Type Hip System With BFH™ Technology to the CONSERVE® Plus Total Hip Resurfacing System

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

June 2006 (Actual)

Primary Completion Date

March 2010 (Actual)

Study Completion Date

March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ottawa Hospital Research Institute

Collaborators

Stryker Trauma GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

A standard hip replacement involves replacing your hip joint with several parts: the cup which forms the socket in the pelvis; a head that forms a new ball for the top of the thigh bone; and a stem which is placed into the thigh bone. Typically, the socket is made out of metal and plastic, and the ball and stem are made out of metal. Recently, new metal-on-metal hip replacement systems have been developed where both the socket and the shell are made out of metal. This can cause metal ions to be released into the body. The CONSERVE® A-Class Total Hip with BFH technology is a new metal-on-metal total hip system which utilizes a large diameter femoral head (36-54 mm) more similar to the size of the original head (i.e., your original bone). Further, this system utilizes an advanced metal design which wears at a slower rate than typical metal-on-metal implants. Therefore, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis

Keywords

osteoarthritis, hip replacement

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CONSERVE® A-Class THA BFH

Arm Type

Active Comparator

Arm Description

Arm Title

CONSERVE® Plus Total Resurfacing Hip System

Arm Type

Active Comparator

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

Blood ion levels

Intervention Description

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

Primary Outcome Measure Information:

Title

blood ion levels

Description

Assessment of Chromium and Cobalt ion levels in the blood

Time Frame

2 years post-operative

Secondary Outcome Measure Information:

Title

functional outcomes radiographic outcomes complication rates

Description

Assessment of clinical efficiency of the implant by validated questionannires and radiographic analysis

Time Frame

2 years post-operatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: (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. (5) Patients who agree to participate and sign the Informed Consent Form. (6) Patients who do not meet any of the exclusion criteria. Exclusion Criteria: (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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul Kim, MD

Organizational Affiliation

Ottawa Hospital Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ottawa Hospital

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1Y 4E9

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

21435499

Citation

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.

Results Reference

result

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

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