A Clinical Investigation of the M2a-Magnum™ Hip System

This study is ongoing, but not recruiting participants.

First Received on June 13, 2008. Last Updated on August 23, 2011 History of Changes

Sponsor:	Biomet Orthopedics, LLC
Information provided by (Responsible Party):	Biomet, Inc. ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier:	NCT00698347

Purpose

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

Condition
Osteoarthritis, Hip Arthritis Rheumatoid Arthritis Joint Disease Bone Disease

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	A Prospective, Non-controlled, Clinical Investigation of the M2a-Magnum™ Hip System

Resource links provided by NLM:

MedlinePlus related topics: Bone Diseases Joint Disorders Osteoarthritis Rheumatoid Arthritis

U.S. FDA Resources

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:

Secondary Outcome Measures:

Incidence of revisions, removals, and/or complications [ Time Frame: Any time ] [ Designated as safety issue: Yes ]
X-Rays [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Enrollment:	249
Study Start Date:	November 2004
Estimated Study Completion Date:	November 2018
Estimated Primary Completion Date:	November 2018 (Final data collection date for primary outcome measure)

Groups/Cohorts
M2a-Magnum™ Hip System

Eligibility

Study Population

Patients that have already made the decision to undergo Total Hip Replacement and will receive the M2a-Magnum™ Hip System

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:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00698347

Sponsors and Collaborators

Biomet Orthopedics, LLC

Investigators

Study Director:

Russell Schenck, PhD

Clinical Research, Biomet Orthopedics, LLC

More Information

No publications provided

Responsible Party:	Biomet, Inc. ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier:	NCT00698347 History of Changes
Other Study ID Numbers:	Biomet 12380-82
Study First Received:	June 13, 2008
Last Updated:	August 23, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Biomet, Inc.:

Total Knee Replacement
Total Knee Arthroplasty
Hip Arthritis

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Bone Diseases
Joint Diseases
Osteoarthritis
Osteoarthritis, Hip

Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012