A Clinical Investigation of the M2a-Magnum™ Hip System

A Prospective, Non-controlled, Clinical Investigation of the M2a-Magnum™ Hip System

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00698347

Enrollment

249

Registered

2008-06-17

Start date

2004-11-30

Completion date

2015-01-31

Last updated

2017-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Bone Disease, Joint Disease, Osteoarthritis, Hip, Rheumatoid Arthritis

Keywords

Total Knee Replacement, Total Knee Arthroplasty, Hip Arthritis

Brief summary

The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the 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.

Interventions

DEVICEM2a-Magnum™ Hip System

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Harris Hip Score	10 years

Secondary

Measure	Time frame
Incidence of revisions, removals, and/or complications	Any time
X-Rays	10 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026