Clinical Outcomes Following Total Joint Replacement With Corin Prostheses: Corin MetaFix Collared Stem

Active, not recruiting

• Conditions: Osteoarthritis, Hip

• Registration Number: NCT05121636
• Lead Sponsor: Corin

Brief Summary

Assessment of the clinical performance and survivorship of the Corin Total Hip System with Trinity™ cup MetaFix™ Collared stem in a prospective study. The primary endpoint of the study is to evaluate the 3-year survivorship and clinical performance of the Corin Total Hip System using Trinity™ cup and MetaFix™ Collared stem. Additionally, the study follow up will continue until 10 years for subjects who consent to do.

Detailed Description

The primary objective is the 3-year survivorship of the study devices.

The Secondary Objectives include:

* The improvement of clinical outcomes:

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

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

* Hip disability and Osteoarthritis Outcome Score (HOOS) up to 10-year follow-up

* Safety performance monitoring including hip- and device-related AEs and the revision rate up to 10-year follow-up

Study Timeline

• Study Start: 2016-06-12
• Primary Completion: 2020-12-02
• Study First Submitted: 2021-11-04
• Study First Submitted QC: 2021-11-04
• Study First Posted: 2021-11-16
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-31
• Last Update Posted: 2023-09-01
• Study Completion: 2027-09-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• Patients requiring a THR

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post operative survivorship of MetaFix Collared Stem at 3-year follow-up	3 years	Survivorship measured via Kaplan-Meier (KM) curve.

Secondary Outcome Measures

Name	Time	Method
Harris Hip Score (HHS) up to 10-year follow-up	Baseline to 10 years	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.
Oxford Hip Score (OHS) up to 10-year follow-up	Baseline to 10 years	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.
Hip- and device-related adverse events up to 10-year follow-up	Baseline to 10 years	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
Hip disability and Osteoarthritis Outcome Score (HOOS) up to 10-year follow-up	Baseline to 10 years	The validated Hip disability and Osteoarthritis Outcome Score questionnaire is designed for patients with hip Osteoarthritis, it consists of 40 questions which assesses Pain, Symptoms, Activities of Daily Living, Sport and Recreational and Hip related Quality of life. To answer the questions, standardized answer options are given in 5 Likert-boxes with scores from 0 to 4 (no, mild, moderate, severe and extreme).; To interpret the score, the outcome measure is transformed in a worst to best scale from 0 to 100, with 100 indicating no symptoms and 0 indicating extreme symptoms.
Post operative survivorship of MetaFix Collared Stem at 10-year follow-up	Baseline to 10 years	Survivorship measured via Kaplan-Meier (KM) curve.
MetaFix Collared Stem radiographic performance up to 10-years	Baseline to 10 years	Radiographic assessment considering radiolucent lines, stem alignment, heterotopic ossifications, osteolysis.