Full Text View
Tabular View
No Study Results Posted
Related Studies
A Clinical Investigation of the M2a- 38™ Hip System
This study has been terminated.
Study NCT00698503   Information provided by Biomet, Inc.
First Received: June 13, 2008   Last Updated: March 6, 2009   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

June 13, 2008
March 6, 2009
January 2002
Harris Hip Score [ Time Frame: 12 weeks, 1 year, 3 years, 5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00698503 on ClinicalTrials.gov Archive Site
Incidence of revisions and removals [ Time Frame: Any time ] [ Designated as safety issue: Yes ]
Same as current
 
A Clinical Investigation of the M2a- 38™ Hip System
M2a- 38™ Hip System Prospective Data Collection

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

 
 
Observational
Cohort, Prospective
  • Non-Inflammatory Degenerative Joint Disease
  • Osteoarthritis
  • Avascular Necrosis
 
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
190
December 2008
December 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
 
 
 
 
NCT00698503
Kenneth Beres, MD. Director Clinical Research, Biomet Orthopedics, LLC
 
Biomet Orthopedics, LLC
 
Study Director: Kenneth J Beres, MD Director, Clinical Research, Biomet Orthopedics, LLC
Biomet, Inc.
March 2009

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.