Metal on Metal Versus Ceramic on Metal Hip Replacement

NCT00208494 | Completed Results

• 1 other identifier: 03062
• Study Type: interventional
• Target: 392
• Locations: 2 countries
• Sites: 9

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.

Conditions

Non-inflammatory Joint Diseases

Keywords

Non-Inflammatory Degenerative Joint Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  At 24 months

Study Arms (2)

A

ACTIVE COMPARATOR

Ceramic-on-metal total hip implant

Device: Total Hip Replacement

B

ACTIVE COMPARATOR

Metal-on-metal total hip implant

Device: Total hip replacement

Interventions

Total hip replacement DEVICE

Total hip replacement

Also known as: Biolox Delta head; Ultamet insert; Pinnacle Acetabular shell

A

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• DePuy Orthopaedics: lead

Study Sites (9)

Foundation for Musculoskeletal Research and Education

Little Rock, Arkansas, 72203, United States

Location

Unknown Facility

Orange, California, 92868, United States

Location

Unknown Facility

Palm Bay, Florida, 32905, United States

Location

Unknown Facility

Charlotte, North Carolina, 28207, United States

Location

Unknown Facility

Cincinnati, Ohio, 45236, United States

Location

Anderson Clinic

Alexandria, Virginia, 22306, United States

Location

Unknown Facility

Roanoke, Virginia, 24018, United States

Location

Unknown Facility

Spokane, Washington, 99218, United States

Location

Unknown Facility

London, Ontario, N6A 5A5, Canada

Location

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: Jennifer Hoag, MS, Project Leader, Clinical Research
• Organization: DePuy Orthopaedics, Inc.

JHoag2@its.jnj.com

574-372-7399

Study Officials

• David Scott, MD

  Orthopaedic Specialty Clinic

  PRINCIPAL INVESTIGATOR

• Patrick G Kirk, MD

  PRINCIPAL INVESTIGATOR

• Shekhar S Desai, MD

  PRINCIPAL INVESTIGATOR

• Charles A Engh, Jr., MD

  Anderson Clinic

  PRINCIPAL INVESTIGATOR

• Ajai Cadambi, MD

  Adult Orthopaedic Reconstruction Texas Hip and Knee Center

  PRINCIPAL INVESTIGATOR

• C L Barnes, MD

  Foundation for Musculoskeletal Research & Education

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: August 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: June 1, 2011
• Last Updated: August 14, 2013
• Results First Posted: August 4, 2011

Record last verified: 2013-08

Locations

US (8); CA (1)