Status:

COMPLETED

A Clinical Investigation of the Taperloc® Microplasty™ Hip System

Lead Sponsor:

Biomet Orthopedics, LLC

Conditions:

Osteoarthritis

Rheumatoid Arthritis

Eligibility:

All Genders

18+ years

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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

  • 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,
  • rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram,
  • vascular insufficiency, muscular atrophy, or neuromuscular disease.

Key Trial Info

Start Date :

August 1 2005

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

March 1 2013

Estimated Enrollment :

98 Patients enrolled

Trial Details

Trial ID

NCT00699309

Start Date

August 1 2005

End Date

March 1 2013

Last Update

June 21 2017

Active Locations (4)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (4 locations)

1

Low Country Bone & Joint Specialists

Beaufort, South Carolina, United States, 29902

2

Piedmont Orthopedics

Greenville, South Carolina, United States, 29615

3

Texas Center for Joint Replacement

Plano, Texas, United States, 75093

4

Arthritis & Sports Orthopaedics

Sterling, Virginia, United States, 20166