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Active, Not Recruiting

NCT Number: NCT05121636

Clinical Outcomes Following Total Joint Replacement With Corin Prostheses: Corin 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Osteoarthritis, Hip Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients requiring a THR

Exclusion criteria

-

Treatment and study plan

MetaFix Collared Stem

Device

Patients received the MetaFix Collared stem during there Total Hip Arthroplasty

Primary outcomes

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

    Time frame: 3 years

    Survivorship measured via Kaplan-Meier (KM) curve.

Secondary outcomes

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

    Time frame: Baseline to 10 years

    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.

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

    Time frame: Baseline to 10 years

    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.

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

    Time frame: Baseline to 10 years

    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.

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

    Time frame: Baseline to 10 years

    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

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

    Time frame: Baseline to 10 years

    Survivorship measured via Kaplan-Meier (KM) curve.

  6. MetaFix Collared Stem radiographic performance up to 10-years

    Time frame: Baseline to 10 years

    Radiographic assessment considering radiolucent lines, stem alignment, heterotopic ossifications, osteolysis.

Sponsors and collaborators

Lead sponsor

Corin

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2027
First posted
Nov 16, 2021
Registry last updated
Sep 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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