A Clinical Investigation of the M2a-Magnum™ Hip System

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00698347
• Other study ID #: Biomet 12380-82
• Status: Terminated
• Phase: N/A
• First received: June 13, 2008
• Last updated: June 19, 2017
• Start date: November 2004
• Est. completion date: January 2015

Study information

• Verified date: June 2017
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 249
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• M2a-Magnum™ Hip System

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biomet Orthopedics, LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Harris Hip Score		10 years
Secondary	Incidence of revisions, removals, and/or complications		Any time
Secondary	X-Rays		10 years