A post-market clinical investigation to evaluate clinical and patient-reported outcomes following a total hip arthroplasty surgery with Trinity™ Dual Mobility System.

Not Applicable

Recruiting

• Conditions: Total Hip Arthroplasty; Osteoarthritis; Musculoskeletal - Osteoarthritis; Surgery - Other surgery

• Registration Number: ACTRN12622000003774
• Lead Sponsor: Corin Australia Pty Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-10
• Last Update Posted: 17 January 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

The individual has signed a Patient Informed Consent Form (PICF), specific to this clinical investigation, and approved by the Human Research Ethics Committee;
Both genders;
Age greater than or equal to 18 years old;
The individual clinically qualifies for Trinity™ Dual Mobility System with a Corin Femoral Stem based on physical examination and medical history.
The individual is willing to comply with the required protocol for follow-up visits.

Additional inclusion criteria for patients participating in the metal-ion analysis:
Willing to provide blood samples.

Exclusion Criteria

Subjects under guardianship;
Subjects with any physical or psychological condition which would impair clinical investigation participation;
Having previous or current hip infection and or a history of metal sensitivity;
Having abnormal renal function
Any patient pregnant or with plans to become pregnant during the course of the clinical investigation.

Additional exclusion criteria for patients participating in the metal-ion analysis (from the prospective group):
Presence of any metal-containing implant in the body outside of the oral cavity
Taking chromium supplements.
Participants who are not willing or able to provide a blood sample

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient-reported disability post-total hip arthroplasty assessed using the Oxford Hip Score (OHS),<br>[Pre-operative (within 4 weeks of surgery), and post-operatively at 6 weeks 6months, 1 year, 2 years and 5 years.]

Secondary Outcome Measures

Name	Time	Method
Assessment of survival rate of the Trinity™ Dual Mobility System after total hip replacement 5 years after surgery by Standard X Ray[Pre-operative (within 4 weeks of surgery), and post-operatively at 6 weeks 6months, 1 year, 2 years and 5 years.];Measurement of metal ions (Co, Cr and Ti) levels from whole blood at a minimum of 2 years after surgery.[Pre-operative blood sample (within 4 weeks of surgery), and post-operatively at 2 years and 5 years.];Patient-reported disability post-total hip arthroplasty assessed using EQ-5D-5L, Hip disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS Junior), Pain Visual Analogue Score (VAS) [Pre-operative (within 4 weeks of surgery), and post-operatively at 6 weeks 6months, 1 year, 2 years and 5 years.]