Study Stopped
Centers would not continue follow-up; two centers transitioned patients to a new study.
A Clinical Investigation of the M2a-Magnum™ Hip System
A Prospective, Non-controlled, Clinical Investigation of the M2a-Magnum™ Hip System
1 other identifier
observational
249
0 countries
N/A
Brief Summary
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the M2a-Magnum™ Hip System
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2004
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 13, 2008
CompletedFirst Posted
Study publicly available on registry
June 17, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedJune 21, 2017
June 1, 2017
10.2 years
June 13, 2008
June 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Harris Hip Score
10 years
Secondary Outcomes (2)
Incidence of revisions, removals, and/or complications
Any time
X-Rays
10 years
Study Arms (1)
M2a-Magnum™ Hip System
Patients who received the M2a-Magnum™ Hip System
Interventions
Eligibility Criteria
Patients that have already made the decision to undergo Total Hip Replacement and will receive the M2a-Magnum™ Hip System
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Russell Schenck, PhD
Clinical Research, Biomet Orthopedics, LLC
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2008
First Posted
June 17, 2008
Study Start
November 1, 2004
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
June 21, 2017
Record last verified: 2017-06