A Clinical Investigation of the M2a- Taper™ 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:
NCT00698633
First received: June 13, 2008
Last updated: October 31, 2012
Last verified: October 2012
  Purpose

The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the M2a- Taper™ 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- Taper™ 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: Postop, 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: 43
Study Start Date: December 2001
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
M2a- Taper™ Hip System
M2a- Taper™ 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- Taper™ 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 diagnoses of:

    1. Osteoarthritis,
    2. Avascular Necrosis,
    3. Traumatic arthritis,
    4. Subcapital fracture,
    5. Legg Perthes,
    6. Slipped Capital Epiphysis,
    7. Fracture of the pelvis,
    8. 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 a 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 prelude 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00698633

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: NCT00698633     History of Changes
Other Study ID Numbers: 12380-5
Study First Received: June 13, 2008
Last Updated: October 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Biomet, Inc.:
Hip arthroplasty

Additional relevant MeSH terms:
Joint Diseases
Necrosis
Osteonecrosis
Osteoarthritis
Musculoskeletal Diseases
Pathologic Processes
Bone Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014