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)
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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