Corin MiniHip and Trinity Cup Clinical Surveillance Study

Corin

Status: Active, not recruiting

Conditions: Total Hip Arthroplasty; Osteoarthritis, Hip; Developmental Dysplasia of the Hip; Rheumatoid Arthritis of Hip; Avascular Necrosis of the Femoral Head; Traumatic Arthritis of Hip

Treatments: Device: Trinity Acetabular Cup System; Device: MiniHip Stem

Study type: Observational

Funder types: Industry

Identifiers

NCT05186168

MH101

Details and patient eligibility

About

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.

Full 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 safety, evaluate patient satisfaction, quality of life and to determine the survivorship following intervention with the Corin MiniHip and Trinity Advanced Bearing Acetabular System at each follow-up visit.

Enrollment: 546 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.