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

Osteoarthritis, Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05121636
• Other study ID #: CSP2016-01
• Status: Active, not recruiting
• Start date: June 12, 2016
• Est. completion date: September 2, 2027

Study information

• Verified date: August 2023
• Source: Corin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 51
• Est. completion date: September 2, 2027
• Est. primary completion date: December 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients requiring a THR

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Osteoarthritis, Hip

Intervention

Device:
• MetaFix Collared Stem
Patients received the MetaFix Collared stem during there Total Hip Arthroplasty

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Corin

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post operative survivorship of MetaFix Collared Stem at 3-year follow-up	Survivorship measured via Kaplan-Meier (KM) curve.	3 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Post operative survivorship of MetaFix Collared Stem at 10-year follow-up	Survivorship measured via Kaplan-Meier (KM) curve.	Baseline to 10 years
Secondary	MetaFix Collared Stem radiographic performance up to 10-years	Radiographic assessment considering radiolucent lines, stem alignment, heterotopic ossifications, osteolysis.	Baseline to 10 years