A Clinical Investigation of the M2a-Magnum™ Hip System

NCT ID: NCT00698347

Last Updated: 2017-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

249 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-11-30

Study Completion Date

2015-01-31

Brief Summary

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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 System

Detailed Description

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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.

Conditions

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Osteoarthritis, Hip Arthritis Rheumatoid Arthritis Joint Disease Bone Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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M2a-Magnum™ Hip System

Patients who received the M2a-Magnum™ Hip System

M2a-Magnum™ Hip System

Intervention Type DEVICE

Interventions

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M2a-Magnum™ Hip System

Intervention Type DEVICE

Other Intervention Names

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Magnum Hip

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biomet Orthopedics, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Russell Schenck, PhD

Role: STUDY_DIRECTOR

Clinical Research, Biomet Orthopedics, LLC

Other Identifiers

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Biomet 12380-82

Identifier Type: -

Identifier Source: org_study_id

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