Corin MiniHip and Trinity Cup Clinical Surveillance Study

NCT ID: NCT05186168

Last Updated: 2023-09-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 546 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-03-15
• Study Completion Date: 2028-05-03

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 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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

MiniHip Stem

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

Intervention Type: DEVICE

Trinity Acetabular Cup System

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• 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.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Corin

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Field

Role: PRINCIPAL_INVESTIGATOR

Elective Orthopaedic Centre, Epsom Hospital, Epsom, Surrey, KT18 7EG

Other Identifiers

MH101

Identifier Type: -

Identifier Source: org_study_id