Status:
COMPLETED
A Clinical Investigation of ArComXL® Polyethylene in Total Hip Replacement
Lead Sponsor:
Zimmer Biomet
Conditions:
Osteoarthritis
Avascular Necrosis
Eligibility:
All Genders
Brief Summary
The purpose of this data collection is to determine long term survival rate of ArComXL® highly cross-linked polyethylene
Detailed Description
Approximately 500 patients (cases) will be enrolled in this data collection effort and 10-year follow-up will be attempted. Follow-up will be obtained by sending a questionnaire directly to the patien...
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 fractures, trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
- Revision of previously failed total hip arthroplasty
- Uncemented applications
Exclusion
- Absolute contraindications
- Infection, sepsis and osteomyelitis
- Relative contraindications
- 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 be 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 :
January 23 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 15 2016
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT00698152
Start Date
January 23 2006
End Date
January 15 2016
Last Update
March 30 2020
Active Locations (5)
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1
The Orthopaedic Center
Rockville, Maryland, United States, 20850
2
The Orthopaedic Institute of Ohio
Lima, Ohio, United States, 45804
3
Ohio Valley Orthopedic and Sports Medicine
West Chester, Ohio, United States, 45069
4
Scranton Orthopaedic Specialists, PC
Dickson City, Pennsylvania, United States, 18519