Corin MiniHip and Trinity Cup Clinical Surveillance Study

N/AActive Not RecruitingNCT05186168

Corin546 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

546

Conditions

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

Interventions

MiniHip StemDEVICE

The MiniHip stem is a titanium femoral stem (Ti-6Al-4V) coated with a layer of hydroxyapatite applied over a layer of pure titanium

Trinity Acetabular Cup SystemDEVICE

The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titanium alloy shell

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Post operative survivorship of the Minihip Stem and Trinity acetabular Cup system at 10-year follow-up

Survivorship measured via Kaplan-Meier (KM) curve

Time frame: 10 years

Secondary Outcomes

Harris Hip Score (HHS) up to 10-year follow-up

Harris Hip Score is a disease-specific scoring system, originally intended as an outcome score after arthroplasty surgeries that includes the domains of function, pain, motion and deformity. Minimum score is 0, Maximum score is 100. The score is reported as 90-100 for excellent results, 80-89 for good, 70-79 for fair, 60-69 for poor, and below 60 for a failed result.

Time frame: Baseline to 10 years

Oxford Hip Score (OHS) up to 10-year follow-up

Oxford Hip Score is a patient-centered questionnaire that is designed to assess functional ability and pain from the patient's perspective. It is a short, twelve-item questionnaire developed for completion by patients undergoing THA. Minimum score 0 indicating worst outcome, maximum score 48 indicating best outcome.

Time frame: Baseline to 10 years

Hip- and device-related adverse events up to 10-year follow-up

All hip-related and device-related complications, including those occurring during the surgical procedure and throughout the postoperative evaluations, are required to be documented and reviewed

Time frame: Baseline to 10 years

Trinity acetabular cup radiographic performance up to 10-years

Radiographic assessment considering Acetabular radiolucent lines using the De lee Charney measurement of zones 1 - 3.

Time frame: Baseline to 10 years

Minihip Stem radiographic performance up to 10-years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.