A Clinical Investigation of the M2a- 38™ Hip System

Condition(s) targeted: Non-Inflammatory Degenerative Joint Disease; Osteoarthritis; Avascular Necrosis

Phase: N/A

Status: Active, not recruiting

Sponsored by: Biomet Orthopedics, Inc.

Official(s) and/or principal investigator(s):
Kenneth J Beres, MD, Study Director, Affiliation: Director, Clinical Research, Biomet Orthopedics, Inc.

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

Official title: M2a- 38™ Hip System Prospective Data Collection

Study design: Cohort, Prospective

Primary outcome:

Harris Hip Score

SF-12 Assessment

Secondary outcome: Incidence of revisions and removals

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 rheumatory 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.

Starting date: January 2002
Ending date: October 2009
Last updated: June 13, 2008