A Clinical Investigation of the M2a-Magnum™ Hip System

Verified by: Biomet, Inc., August 2011
First Received: June 13, 2008 | Last Updated: August 23, 2011 | Phase: N/A | Start Date: November 2004
Overall Status: Active, not recruiting | Estimated Enrollment: 249
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The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the M2a-Magnum™ Hip...

Brief Summary

Official Title: “A Prospective, Non-controlled, Clinical Investigation of the M2a-Magnum™ Hip System”

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

  • Study Type: Observational
  • Study Design: Observational Model: Cohort, Time Perspective: Prospective
  • Study Primary Completion Date: November 2018

Arms, Groups and Cohorts in this Clinical Trial

  • : M2a-Magnum™ Hip System

Outcome Measures for this Clinical Trial

Primary Measures

  • Harris Hip Score
    • Time Frame: 10 years
      Safety Issue?: No

Secondary Measures

  • Incidence of revisions, removals, and/or complications
    • Time Frame: Any time
      Safety Issue?: Yes
  • X-Rays
    • Time Frame: 10 years
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Biomet Orthopedics, LLC Industry

Overall Clinical Trial Officials and Contacts

Russell Schenck, PhD Study Director Clinical Research, Biomet Orthopedics, LLC  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00698347

Study ID Number: Biomet 12380-82

ClinicalTrials.gov Identifier: NCT00698347

Health Authority: United States: Institutional Review Board

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00698347