ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
A Clinical Investigation of the M2a- Taper™ Hip System

This study is ongoing, but not recruiting participants.

Sponsored by: Biomet Orthopedics, LLC
Information provided by: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT00698633
  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

MedlinePlus related topics:   Joint Disorders    Osteoarthritis    Osteonecrosis   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Cohort, Prospective
Official Title:   M2a- Taper™ Hip System Prospective Data Collection

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 ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Enrollment:   43
Study Start Date:   December 2001
Estimated Study Completion Date:   April 2009
Estimated Primary Completion Date:   April 2009 (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


Responsible Party:   Biomet Orthopedics, LLC ( Ken Beres, MD., Director of Clinical Research )
Study ID Numbers:   12380-5
First Received:   June 13, 2008
Last Updated:   July 21, 2008
ClinicalTrials.gov Identifier:   NCT00698633
Health Authority:   United States: Institutional Review Board

Keywords provided by Biomet, Inc.:
Hip arthroplasty  

Study placed in the following topic categories:
Necrosis
Musculoskeletal Diseases
Osteonecrosis
Osteoarthritis
Arthritis
Joint Diseases
Rheumatic Diseases
Bone Diseases

Additional relevant MeSH terms:
Pathologic Processes

ClinicalTrials.gov processed this record on October 10, 2008




Links to all studies - primarily for crawlers