A Clinical Investigation of the M2a- 38™ Hip System

This study has been terminated.
(due to low follow up)
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc. ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier:
NCT00698503
First received: June 13, 2008
Last updated: March 19, 2014
Last verified: October 2012
  Purpose

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


Condition
Non-inflammatory Degenerative Joint Disease
Osteoarthritis
Avascular Necrosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: M2a- 38™ Hip System Prospective Data Collection

Resource links provided by NLM:


Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Harris Hip Score [ Time Frame: 12 weeks, 1 year, 3 years, 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of revisions and removals [ Time Frame: Any time ] [ Designated as safety issue: Yes ]

Enrollment: 190
Study Start Date: January 2002
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
M2a- 38™ Hip System

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00698503

Sponsors and Collaborators
Biomet Orthopedics, LLC
Investigators
Study Director: Kenneth J Beres, MD Director, Clinical Research, Biomet Orthopedics, LLC
  More Information

No publications provided

Responsible Party: Biomet, Inc. ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier: NCT00698503     History of Changes
Other Study ID Numbers: 12380-6
Study First Received: June 13, 2008
Last Updated: March 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Biomet, Inc.:
Metal on Metal
Total Hip Arthroplasty
Total Hip Replacement

Additional relevant MeSH terms:
Osteoarthritis
Joint Diseases
Arthritis
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 16, 2014