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
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
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 April 15, 2014