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A Clinical Investigation of the M2a- 38™ Hip System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00698503
Recruitment Status : Terminated (due to low follow up)
First Posted : June 17, 2008
Last Update Posted : June 21, 2017
Information provided by (Responsible Party):
Zimmer Biomet ( Biomet Orthopedics, LLC )

Brief Summary:
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the M2a- 38™ Hip System

Condition or disease
Non-inflammatory Degenerative Joint Disease Osteoarthritis Avascular Necrosis

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Study Type : Observational
Actual Enrollment : 190 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: M2a- 38™ Hip System Prospective Data Collection
Study Start Date : January 2002
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

M2a- 38™ Hip System

Primary Outcome Measures :
  1. Harris Hip Score [ Time Frame: 12 weeks, 1 year, 3 years, 5 years ]

Secondary Outcome Measures :
  1. Incidence of revisions and removals [ Time Frame: Any time ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients that have already made the decision to undergo Total Hip Replacement and will receive the M2a- 38™ Hip System

Inclusion Criteria:

  • Patients having primary cemented or cementless total hip replacement for non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnosis of osteoarthritis, avascular necrosis, traumatic arthritis, subcapital fracture, legg perthes, slipped capital epiphysis, fracture of the pelvis, diastrophic variant.
  • Patients with full skeletal maturity
  • Patients undergoing unilateral total hip arthroplasty or bilateral total hip arthroplasty, either staged or simultaneously
  • Patients of all races and gender
  • Patients who are able to follow postoperative care instructions
  • Patients who are able and willing to return for follow-up evaluations
  • Patients have preoperative total Harris Hip Score less than 70 with at least moderate pain.

Exclusion Criteria:

  • Patients diagnosed with inflammatory degenerative arthritis (IDJD) to include the following composite diagnoses: rheumatoid arthritis, systemic lupus erythematous, pigmented villonodular synovitis, juvenile rheumatoid arthritis and other arthritic processes of inflammatory or autoimmune etiology.
  • Patients less than 18 years.
  • Patients with the presence of a previous prosthetic hip replacement device (any type, including surface replacement arthroplasty, endoprosthesis, etc.)in the hip joint to be operated.
  • Patients with previous Girdlestone procedures.
  • Patients with above the knee amputation of the contralateral and/or ipsilateral leg.
  • Patients with osteoporosis, or marked bone loss which would preclude proper fixation of the prosthesis.
  • Patients who are pregnant.
  • Patients with an active or suspected infection in or around the hip.
  • Patients with Parkinson's disease.
  • Patients with vascular insufficiency, muscular atrophy, or neuromuscular disease in the affected limb.
  • Patients with severe instability or deformity of the ligaments and/or surrounding soft tissue which would preclude stability of the prosthesis.
  • Patients with a highly communicable disease or diseases that may limit follow-up (e.g. immuno-compromised conditions, hepatitis, active tuberculosis, neoplastic disease, etc.).
  • Patients unwilling or unable to comply with a rehabilitation program for a cemented or cementless total hip replacement or who indicate difficulty or inability to return for follow-up visits prescribed by the study protocol.
  • Patients with previous hip surgery or conditions that may interfere with the total hip replacement's survival or outcome, e.g., Paget's disease, Charcot's disease, severe osteoporosis compromising bone stock (Dorr type C bone).
  • Patients who qualify for inclusion in the study, but refuse consent to participate in the study.
  • Patients with a "fused" hip.
  • Patients who have had a total hip arthroplasty on the contralateral hip within the last year.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00698503

Sponsors and Collaborators
Biomet Orthopedics, LLC
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Study Director: Kenneth J Beres, MD Director, Clinical Research, Biomet Orthopedics, LLC
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Responsible Party: Biomet Orthopedics, LLC Identifier: NCT00698503    
Other Study ID Numbers: 12380-6
First Posted: June 17, 2008    Key Record Dates
Last Update Posted: June 21, 2017
Last Verified: June 2017
Keywords provided by Zimmer Biomet ( Biomet Orthopedics, LLC ):
Metal on Metal
Total Hip Arthroplasty
Total Hip Replacement
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pathologic Processes