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A Clinical Investigation of the M2a-Magnum™ Hip System

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ClinicalTrials.gov Identifier: NCT00698347
Recruitment Status : Terminated (Centers would not continue follow-up; two centers transitioned patients to a new study.)
First Posted : June 17, 2008
Last Update Posted : June 21, 2017
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet ( Biomet Orthopedics, LLC )

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

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

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.


Study Type : Observational
Actual Enrollment : 249 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Non-controlled, Clinical Investigation of the M2a-Magnum™ Hip System
Study Start Date : November 2004
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
M2a-Magnum™ Hip System
Patients who received the M2a-Magnum™ Hip System
Device: M2a-Magnum™ Hip System
Other Name: Magnum Hip



Primary Outcome Measures :
  1. Harris Hip Score [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. Incidence of revisions, removals, and/or complications [ Time Frame: Any time ]
  2. X-Rays [ Time Frame: 10 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00698347


Sponsors and Collaborators
Biomet Orthopedics, LLC
Investigators
Study Director: Russell Schenck, PhD Clinical Research, Biomet Orthopedics, LLC

Responsible Party: Biomet Orthopedics, LLC
ClinicalTrials.gov Identifier: NCT00698347     History of Changes
Other Study ID Numbers: Biomet 12380-82
First Posted: June 17, 2008    Key Record Dates
Last Update Posted: June 21, 2017
Last Verified: June 2017

Keywords provided by Zimmer Biomet ( Biomet Orthopedics, LLC ):
Total Knee Replacement
Total Knee Arthroplasty
Hip Arthritis

Additional relevant MeSH terms:
Arthritis
Osteoarthritis
Arthritis, Rheumatoid
Joint Diseases
Bone Diseases
Osteoarthritis, Hip
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases