A Clinical Investigation of the M2a- 38™ Hip System

Zimmer Biomet

Status: Terminated

Conditions: Non-inflammatory Degenerative Joint Disease; Osteoarthritis; Avascular Necrosis

Study type: Observational

Funder types: Industry

Identifiers

NCT00698503

12380-6

Details and patient eligibility

About

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

Enrollment: 190 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

190 participants in 1 patient group

M2a- 38™ Hip System