Clinical trial NCT00698503: A Clinical Investigation of the M2a- 38™ Hip System
Official title: M2a- 38™ Hip System Prospective Data Collection
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Non-inflammatory Degenerative Joint Disease
Osteoarthritis
Avascular Necrosis
Keywords: Metal on Metal
Total Hip Arthroplasty
Total Hip Replacement
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2008-06-17
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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


Eligibility 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.

Primary outcomes:
measure: Harris Hip Score
timeFrame: 12 weeks, 1 year, 3 years, 5 years
Secondary outcomes:
measure: Incidence of revisions and removals
timeFrame: Any time
Other outcomes:
Locations:
Study officials:
affiliation: Director, Clinical Research, Biomet Orthopedics, LLC
name: Kenneth J Beres, MD
role: STUDY_DIRECTOR
References: