An observational study in Osteoarthritis, Hip, sponsored by Corin. Active, not recruiting. Per ClinicalTrials.gov, last updated 2023-09-01.
Sponsored by Corin · Observational
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.
The primary objective is the 3-year survivorship of the study devices.
The Secondary Objectives include:
The improvement of clinical outcomes:
628 studies on the registry are indexed under Osteoarthritis, Hip; 121 are open to participants now.
This study's enrollment of 51 is below the median of 141 across 154 observational studies indexed under Osteoarthritis, Hip.
Browse Osteoarthritis, Hip studies →Corin is the lead sponsor of 19 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
-
Patients received the MetaFix Collared stem during there Total Hip Arthroplasty
Post operative survivorship of MetaFix Collared Stem at 3-year follow-up
Survivorship measured via Kaplan-Meier (KM) curve.
Time frame: 3 years
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.
Time frame: Baseline to 10 years
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.
Time frame: Baseline to 10 years
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.
Time frame: Baseline to 10 years
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
Time frame: Baseline to 10 years
Post operative survivorship of MetaFix Collared Stem at 10-year follow-up
Survivorship measured via Kaplan-Meier (KM) curve.
Time frame: Baseline to 10 years
MetaFix Collared Stem radiographic performance up to 10-years
Radiographic assessment considering radiolucent lines, stem alignment, heterotopic ossifications, osteolysis.
Time frame: Baseline to 10 years
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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