Status:
ACTIVE_NOT_RECRUITING
Corin MiniHip and Trinity Cup Clinical Surveillance Study
Lead Sponsor:
Corin
Conditions:
Total Hip Arthroplasty
Osteoarthritis, Hip
Eligibility:
All Genders
18-75 years
Brief Summary
The aim of the study is to provide long term follow up data on the performance and safety of the Corin MiniHip and Trinity acetabular cup over a 10-year period.
Detailed Description
To verify the ten-year clinical and radiographic performance of the Corin MiniHip and Trinity Advanced Bearing Acetabular System when used in patients under normal conditions of use. To document the ...
Eligibility Criteria
Inclusion
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis or developmental dysplasia of the hip.
- Avascular necrosis of the femoral head
- All subjects must be between the age of 18 and 75 at the time of surgery to take part in this study
- Scheduled for a primary total hip replacement.
Exclusion
- Active infection
- Severe Obesity (BMI over 35)
- Pregnancy
- Mental illness
- Grossly distorted anatomy (surgeon's discretion)
- Sepsis
- Osteomyelitis
- Osteomalacia
- Distant foci of infections
- Osteoporosis
- Metabolic disorders which may impair bone formation
- Muscular atrophy or neuromuscular disease
- Allergy to implant material
- Marked bone loss or bone resorption
- Patients without sufficient quantities of synovial fluid to allow for proper lubrication, such as patients with Sjogren's syndrome
- Skeletally immature patients and cases where there is a loss of abductor musculature, poor bone stock or poor skin coverage around the hip joint which would make the procedure inappropriate
- Any case not described in the inclusion criteria
- Any patient who cannot or will not provide informed consent for participation in the study
- Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems.
Key Trial Info
Start Date :
March 15 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 3 2028
Estimated Enrollment :
546 Patients enrolled
Trial Details
Trial ID
NCT05186168
Start Date
March 15 2011
End Date
May 3 2028
Last Update
September 1 2023
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