Metal on Metal Versus Ceramic on Metal Hip Replacement

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Total Hip Replacement

Total hip replacement

About this trial

This is an interventional treatment trial for Non-inflammatory Joint Diseases focused on measuring Non-Inflammatory Degenerative Joint Disease

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Able to (or capable of) provide consent to participate in the clinical investigation prior to the day of the surgery. Skeletally mature (tibial and femoral epiphyses are closed) Undergoing cementless primary hip replacement surgery for Noninflammatory Degenerative Joint Disease Affected hip has a Harris Hip Score of 70 or lower and a Pain rating of Moderate or greater Radiographic Parameters: X-Ray Evaluation confirms the presence of NIDJD Femoral and acetabular bone stock is sufficient, regarding strength and shape, and is suitable to receive the implants No structural bone grafts required to support to prosthetic component(s)or to shape the bone to receive implant(s) Willing to have knowledge of treatment arm (CoM or MoM) withheld for a period of 24 months post-operatively unless disclosure is legally and/or medically necessary Previous THA in contralateral hip that is greater than one (1) year postoperative and has a Harris Hip pain rating less than MILD Exclusion Criteria: Bilateral hip disease with the anticipated need for bilateral hip implant during study participation (i.e., within the next 24 months) THA required for the revision of a previously failed THA Suffering from inflammatory arthritis Prior prosthetic hip replacement Previous Girdlestone procedure or surgical fusion in the operative hip joint Above knee amputation of either the contralateral or ipsilateral leg Known allergy to metal (e.g. jewelry) The presence of highly communicable disease or diseases that may limit follow-up (e.g., immuno-compromised conditions, hepatitis, active tuberculosis, etc.) Significant neurological or musculoskeletal disorders or disease that may adversely affect gait or weight bearing (e.g., muscular dystrophy, multiple sclerosis) Conditions that may interfere with the total hip arthroplasty survival or outcome (e.g., Paget's disease, Charcot's disease) Unwilling or unable to comply with a rehabilitation program for a cementless THA or difficulty or inability to return for follow-up visits prescribed by the study protocol Known to be pregnant, a prisoner, mentally incompetent, and/or alcohol or drug abuser Previous treatment for renal disease Any systemic steroid therapy, excluding inhalers, within three months prior to surgery

Sites / Locations

Foundation for Musculoskeletal Research and Education
Anderson Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

A

B

Arm Description

Ceramic-on-metal total hip implant

Metal-on-metal total hip implant

Outcomes

Primary Outcome Measures

Composite Success/Failure

The composite success/failure of the implant was made up of radiographic, clinical and revision data. Radiographic success was determined by femoral subsidence =/< 2mm, acetabular migration =/< 2mm, cup inclination =/< 4°, no acetabular or femoral osteolysis, and acetabular and femoral lucencies less than 50% of visible porous coating. Clinical success was determined by a Harris Hip score equal to or greater than 80. A hip (patient) was considered to be a composite success at study endpoint if it was a radiographic and clinical success and no revision of any component had taken place.

Secondary Outcome Measures

Full Information

NCT ID

NCT00208494

First Posted

September 13, 2005

Last Updated

August 6, 2013

Sponsor

DePuy Orthopaedics

1. Study Identification

Unique Protocol Identification Number

NCT00208494

Brief Title

Metal on Metal Versus Ceramic on Metal Hip Replacement

Official Title

Comparative Study to Evaluate the Safety and Efficacy of the DePuy Ceramic-on-metal Total Hip Prosthesis Versus the DePuy Metal-on-metal Total Hip Prosthesis Through Clinical and Radiographical Data

Study Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Completed

Study Start Date

August 2005 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

DePuy Orthopaedics

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

The purpose of this study is to compare the performance of artificial hips with metal heads and metal sockets to artificial hips with ceramic heads articulating with metal socket components. The success of the total hip arthroplasty (THA) will be based upon all of the following clinical and radiographic criteria being met at the two-year evaluation: (1) the patient's clinical results as measured using modified Harris Hip evaluation rating system, and the absence of a complication that requires the surgical removal or replacement of a component; and (2) radiographic findings at study endpoint (i.e., two years follow-up). Clinical and radiographic success at two (2) years postoperative is required for the study hip to be deemed successful.

Detailed Description

This study is a prospective, multi-center, randomized, single blind, controlled clinical investigation comparing the safety and efficacy of the cementless Ceramic on Metal total hip prostheses versus the cementless Metal on Metal total hip prostheses.

6. Conditions and Keywords

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

Non-inflammatory Joint Diseases

Keywords

Non-Inflammatory Degenerative Joint Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

392 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A

Arm Type

Active Comparator

Arm Description

Ceramic-on-metal total hip implant

Arm Title

B

Arm Type

Active Comparator

Arm Description

Metal-on-metal total hip implant

Intervention Type

Device

Intervention Name(s)

Total Hip Replacement

Other Intervention Name(s)

Biolox Delta head; Ultamet insert; Pinnacle Acetabular shell

Intervention Description

Total hip replacement

Intervention Type

Device

Intervention Name(s)

Total hip replacement

Other Intervention Name(s)

CoCr M-head, Ultamet insert, Pinnacle Acetabular shell

Intervention Description

Total hip replacement

Primary Outcome Measure Information:

Title

Composite Success/Failure

Description

The composite success/failure of the implant was made up of radiographic, clinical and revision data. Radiographic success was determined by femoral subsidence =/< 2mm, acetabular migration =/< 2mm, cup inclination =/< 4°, no acetabular or femoral osteolysis, and acetabular and femoral lucencies less than 50% of visible porous coating. Clinical success was determined by a Harris Hip score equal to or greater than 80. A hip (patient) was considered to be a composite success at study endpoint if it was a radiographic and clinical success and no revision of any component had taken place.

Time Frame

At 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Able to (or capable of) provide consent to participate in the clinical investigation prior to the day of the surgery. Skeletally mature (tibial and femoral epiphyses are closed) Undergoing cementless primary hip replacement surgery for Noninflammatory Degenerative Joint Disease Affected hip has a Harris Hip Score of 70 or lower and a Pain rating of Moderate or greater Radiographic Parameters: X-Ray Evaluation confirms the presence of NIDJD Femoral and acetabular bone stock is sufficient, regarding strength and shape, and is suitable to receive the implants No structural bone grafts required to support to prosthetic component(s)or to shape the bone to receive implant(s) Willing to have knowledge of treatment arm (CoM or MoM) withheld for a period of 24 months post-operatively unless disclosure is legally and/or medically necessary Previous THA in contralateral hip that is greater than one (1) year postoperative and has a Harris Hip pain rating less than MILD Exclusion Criteria: Bilateral hip disease with the anticipated need for bilateral hip implant during study participation (i.e., within the next 24 months) THA required for the revision of a previously failed THA Suffering from inflammatory arthritis Prior prosthetic hip replacement Previous Girdlestone procedure or surgical fusion in the operative hip joint Above knee amputation of either the contralateral or ipsilateral leg Known allergy to metal (e.g. jewelry) The presence of highly communicable disease or diseases that may limit follow-up (e.g., immuno-compromised conditions, hepatitis, active tuberculosis, etc.) Significant neurological or musculoskeletal disorders or disease that may adversely affect gait or weight bearing (e.g., muscular dystrophy, multiple sclerosis) Conditions that may interfere with the total hip arthroplasty survival or outcome (e.g., Paget's disease, Charcot's disease) Unwilling or unable to comply with a rehabilitation program for a cementless THA or difficulty or inability to return for follow-up visits prescribed by the study protocol Known to be pregnant, a prisoner, mentally incompetent, and/or alcohol or drug abuser Previous treatment for renal disease Any systemic steroid therapy, excluding inhalers, within three months prior to surgery

Overall Study Officials: