A Clinical Investigation of the M2a-Magnum™ Hip System

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc. ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier:
NCT00698347
First received: June 13, 2008
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention
Osteoarthritis, Hip
Arthritis
Rheumatoid Arthritis
Joint Disease
Bone Disease
Device: M2a-Magnum™ Hip System

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:


Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Harris Hip Score [ Time Frame: 10 years ] [ Designated as safety issue: No ]

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 Assigned Interventions
M2a-Magnum™ Hip System
Patients who received the M2a-Magnum™ Hip System
Device: M2a-Magnum™ Hip System
Other Name: Magnum Hip

Detailed Description:

This is a 10 year prospective data collection documenting the function and survivorship of the M2a-Magnum™ Hip System. Patients are required to come in for preoperative, operative, one year follow-up, three year follow-up, five year follow-up, and ten year follow-up exams.

This product was FDA cleared in 2004.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: December 17, 2013
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
Osteoarthritis
Bone Diseases
Joint Diseases
Osteoarthritis, Hip
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 16, 2014