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

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 190

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
M2a- 38™ Hip System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Harris Hip Score	12 weeks, 1 year, 3 years, 5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of revisions and removals	Any time

Collaborators and Investigators

• Sponsor: Biomet Orthopedics, LLC
• Investigators: Study Director: Kenneth J Beres, MD, Director, Clinical Research, Biomet Orthopedics, LLC

Study record dates

Study Major Dates

• Study Start: January 1, 2002
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: June 13, 2008
• First Submitted That Met QC Criteria: June 13, 2008
• First Posted (Estimate): June 17, 2008

Study Record Updates

• Last Update Posted (Actual): June 21, 2017
• Last Update Submitted That Met QC Criteria: June 19, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Total Hip Arthroplasty; Total Hip Replacement; Metal on Metal
• Additional Relevant MeSH Terms: Pathologic Processes; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Joint Diseases; Necrosis
• Other Study ID Numbers: 12380-6