A Clinical Investigation of the M2a-Magnum™ Hip System

Condition(s) targeted: Osteoarthritis, Hip; Arthritis; Rheumatoid Arthritis; Joint Disease; Bone Disease

Phase: N/A

Status: Enrolling by invitation

Sponsored by: Biomet Orthopedics, Inc.

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

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

Official title: A Prospective, Non-Controlled, Clinical Investigation of the M2a-Magnum™ Hip System

Study design: Cohort, Prospective

Primary outcome:

Harris Hip Score

X-rays

Secondary outcome: Incidence of revisions, removals, and/or complications

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

Criteria:

Inclusion Criteria:

- Non-inflammatory degenerative joint disease including: Avascular Necrosis,

Diastrophic Variant, Fracture of the Pelvis, Fused Hip, Leg Perthes, Osteoarthritis, Slipped Capital Epiphysis, Subcapital Fractures, Traumatic Arthritis

- Rheumatoid Arthritis

- Correction of Functional Deformity

- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the

proximal femur with head involvement, unmanageable by other techniques

- Revision of previously failed total hip arthroplasty

Exclusion Criteria:

Absolute contraindications include:

- Infection, Sepsis, and Osteomyelitis

Relative contraindications include:

- Uncooperative patient or patient with neurologic disorders that are incapable of

following directions

- Osteoporosis

- Metabolic disorders which may impair bone formation

- Osteomalacia

- Distant foci of infections which may spread to the implant site

- Rapid joint destruction, marked bone loss, or bone resorption apparent on

roentgenogram

- Vascular insufficiency, muscular atrophy, or neuromuscular disease

Starting date: November 2004
Ending date: November 2018
Last updated: June 13, 2008