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

Clinical Outcomes Following Total Joint Replacement With Corin Prostheses : Trinity™ Cup and MetaFix™ Collared Stem

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Osteoarthritis, Hip
• Intervention / Treatment: Device: MetaFix Collared Stem

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 Type: Observational
• Enrollment (Actual): 51

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients requiring a THR were identified and screened according to the Indications for use and the contraindications for implantation of the MetaFix™ collared femoral stem and the Trinity™ acetabular cup were invited to consent to the study. No specific exclusion criteria were defined for this study.

Description

Inclusion Criteria:

• Patients requiring a THR

Exclusion Criteria:

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post operative survivorship of MetaFix Collared Stem at 3-year follow-up	Survivorship measured via Kaplan-Meier (KM) curve.	3 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
Hip disability and Osteoarthritis Outcome Score (HOOS) up to 10-year follow-up	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.	Baseline to 10 years
Post operative survivorship of MetaFix Collared Stem at 10-year follow-up	Survivorship measured via Kaplan-Meier (KM) curve.	Baseline to 10 years
MetaFix Collared Stem radiographic performance up to 10-years	Radiographic assessment considering radiolucent lines, stem alignment, heterotopic ossifications, osteolysis.	Baseline to 10 years

Collaborators and Investigators

• Sponsor: Corin
• Investigators: Principal Investigator: Steve Barnett, Hoag Orthopedic Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2016
• Primary Completion (Actual): December 2, 2020
• Study Completion (Estimated): September 2, 2027

Study Registration Dates

• First Submitted: November 4, 2021
• First Submitted That Met QC Criteria: November 4, 2021
• First Posted (Actual): November 16, 2021

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: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: CSP2016-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

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