Corin MiniHip and Trinity Cup Clinical Surveillance Study

The Corin MiniHip and Trinity Advanced Bearing Acetabular Cup System UK Clinical Surveillance Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Developmental Dysplasia of the Hip; Osteoarthritis, Hip; Total Hip Arthroplasty; Avascular Necrosis of the Femoral Head; Rheumatoid Arthritis of Hip; Traumatic Arthritis of Hip
• Intervention / Treatment: Device: MiniHip Stem; Device: Trinity Acetabular Cup System

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.

• Study Type: Observational
• Enrollment (Actual): 546

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Suitable participants undergoing primary total hip replacement with the Corin MiniHip and Trinity Advanced Bearing Acetabular System.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post operative survivorship of the Minihip Stem and Trinity acetabular Cup system at 10-year follow-up	Survivorship measured via Kaplan-Meier (KM) curve	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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.	Baseline to 10 years
Minihip Stem radiographic performance up to 10-years	Radiographic assessment considering osteolysis and femoral stem alignment measured as Varus/Valgus and the use of the Gruen's assessment zones 1-7	Baseline to 10 years
Minihip Stem and Trinity acetabular cup radiographic performance up to 10-years	Radiographic assessment considering heterotopic ossifications using the Brooker classification Grade 1 - 4.	Baseline to 10 years

Collaborators and Investigators

• Sponsor: Corin
• Investigators: Principal Investigator: Richard Field, Elective Orthopaedic Centre, Epsom Hospital, Epsom, Surrey, KT18 7EG

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2011
• Primary Completion (Estimated): May 3, 2028
• Study Completion (Estimated): May 3, 2028

Study Registration Dates

• First Submitted: December 15, 2021
• First Submitted That Met QC Criteria: January 6, 2022
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Congenital Abnormalities; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Musculoskeletal Abnormalities; Joint Dislocations; Osteoarthritis; Hip Dislocation; Arthritis; Necrosis; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital; Osteoarthritis, Hip
• Other Study ID Numbers: MH101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No