Osteoarthritis, HipNCT05121636
Clinical Outcomes Following Total Joint Replacement With Corin Prostheses: Corin MetaFix Collared Stem
An observational study of Osteoarthritis, Hip, run by Corin.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Hip
- What is being tested?
- MetaFix Collared Stem
- Type of treatment
- Medical device
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- 12 Jun 2016to 2 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients requiring a THR
Who cannot join
- -
About this study
Official title: Clinical Outcomes Following Total Joint Replacement With Corin Prostheses : Trinity™ Cup and 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.
Read the 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
- Being tested
- MetaFix Collared Stem
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetaFix Collared StemDevice
Patients received the MetaFix Collared stem during there Total Hip Arthroplasty
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative survivorship of MetaFix Collared Stem at 3-year follow-up
Survivorship measured via Kaplan-Meier (KM) curve.
Measured: 3 years
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline to 10 years
Post operative survivorship of MetaFix Collared Stem at 10-year follow-up
Survivorship measured via Kaplan-Meier (KM) curve.
Measured: Baseline to 10 years
MetaFix Collared Stem radiographic performance up to 10-years
Radiographic assessment considering radiolucent lines, stem alignment, heterotopic ossifications, osteolysis.
Measured: Baseline to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start12 Jun 2016
- Primary completion2 Dec 2020
- Study completion2 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corin
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steve Barnett, Principal investigator, Hoag Orthopedic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05121636
- Sponsor's protocol ID
- CSP2016-01
- Status last verified
- Aug 2023
- First submitted
- 4 Nov 2021
- Last updated
- 1 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes Following Total Joint Replacement With Corin Prostheses : Trinity™ Cup and MetaFix™ Collared Stem
- ClinicalTrials.gov ID
- NCT05121636
- Acronym / sponsor ID
- CSP2016-01
- Conditions
- Osteoarthritis, Hip
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 51 participants (actual)
- Lead sponsor
- CorinIndustry (pharma, biotech, devices)
- Study start
- 12 Jun 2016 (actual)
- Primary completion
- 2 Dec 2020 (actual)
- Study completion
- 2 Sep 2027 (estimated)
- First posted
- 16 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients requiring a THR
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetaFix Collared StemPatients received the MetaFix Collared stem during there Total Hip Arthroplasty | Device | – |
Primary outcome
Post operative survivorship of MetaFix Collared Stem at 3-year follow-up
Time frame: 3 years
Survivorship measured via Kaplan-Meier (KM) curve.
6 secondary outcomes
Harris Hip Score (HHS) up to 10-year follow-up
Time frame: Baseline to 10 years
Oxford Hip Score (OHS) up to 10-year follow-up
Time frame: Baseline to 10 years
Hip disability and Osteoarthritis Outcome Score (HOOS) up to 10-year follow-up
Time frame: Baseline to 10 years
Hip- and device-related adverse events up to 10-year follow-up
Time frame: Baseline to 10 years
Post operative survivorship of MetaFix Collared Stem at 10-year follow-up
Time frame: Baseline to 10 years
MetaFix Collared Stem radiographic performance up to 10-years
Time frame: Baseline to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve Barnett principal investigator
Hoag Orthopedic Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Hip, run by Corin.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative survivorship of MetaFix Collared Stem at 3-year follow-up (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.