NCT05121636

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 51 (actual)
• Sponsor: Corin · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Conditions

• Osteoarthritis, Hip

Interventions

Type	Name	Description
DEVICE	MetaFix Collared Stem	Patients received the MetaFix Collared stem during there Total Hip Arthroplasty

Timeline

• Start date: 2016-06-12
• Primary completion: 2020-12-02
• Completion: 2027-09-02
• First posted: 2021-11-16
• Last updated: 2023-09-01

Regulatory

• FDA-regulated device study