NCT05121636

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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
16mo left

Started Jun 2016

Longer than P75 for all trials

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Jun 2016Sep 2027

Study Start

First participant enrolled

June 12, 2016

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 16, 2021

Completed
5.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2027

Expected
Last Updated

September 1, 2023

Status Verified

August 1, 2023

Enrollment Period

4.5 years

First QC Date

November 4, 2021

Last Update Submit

August 31, 2023

Conditions

Osteoarthritis, Hip

Outcome Measures

Primary Outcomes (1)

  • Post operative survivorship of MetaFix Collared Stem at 3-year follow-up

    Survivorship measured via Kaplan-Meier (KM) curve.

    3 years

Secondary Outcomes (6)

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

    Baseline to 10 years

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

    Baseline to 10 years

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

    Baseline to 10 years

  • Hip- and device-related adverse events up to 10-year follow-up

    Baseline to 10 years

  • Post operative survivorship of MetaFix Collared Stem at 10-year follow-up

    Baseline to 10 years

  • +1 more secondary outcomes

Interventions

MetaFix Collared StemDEVICE

Patients received the MetaFix Collared stem during there Total Hip Arthroplasty

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Patients requiring a THR

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Steve Barnett

    Hoag Orthopedic Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2021

First Posted

November 16, 2021

Study Start

June 12, 2016

Primary Completion

December 2, 2020

Study Completion (Estimated)

September 2, 2027

Last Updated

September 1, 2023

Record last verified: 2023-08