A Prospective, Non-controlled, Clinical Investigation of the Taperloc® Microplasty™ Hip System

Biomet Orthopedics, LLC4 sites in 1 country98 target enrollmentAugust 2005

ConditionsOsteoarthritis Rheumatoid Arthritis Avascular Necrosis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Osteoarthritis
Sponsor: Biomet Orthopedics, LLC
Enrollment: 98
Locations: 4
Primary Endpoint: Harris Hip Score
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Taperloc® Microplasty™ Hip System.

Registry

clinicaltrials.gov

Start Date

August 2005

End Date

March 2013

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Biomet Orthopedics, LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
•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 femoral head resurfacing component

Exclusion Criteria

•Absolute contraindications include:
•infection,
•sepsis, and
•osteomyelitis.
•Relative contraindications include:
•uncooperative patient or patient with neurologic disorders who 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,