Hip DiseaseNCT06153940
Everglade Stem, World Cup and World Liner Post Market Clinical Follow-up
An observational study of Hip Disease, run by Signature Orthopaedics at 1 site in United States.
Trial summary
The aim of the Study is to monitor the performance of the Signature Orthopaedics Everglade Stem, World Acetabular Cup and World Liner as a part of post-market vigilance and continuous improvement efforts. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hip Disease
- What is being tested?
- Treatment
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2023to 1 Mar 2028
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of the Cleveland Clinic
Who may be able to join
- patient requires unilateral primary total hip arthroplasty due to non-inflammatory degenerative joint disease (e.g. osteoarthritis, traumatic arthritis, avascular necrosis, dysplasia/DDH)
- patient must be a candidate for use of the products studied, as determined jointly by the surgeon and patient
- male and non-pregnant female patients aged 18-75
- patients who understand the conditions of the clinical evaluation and are willing to participate for the length of the prescribed follow-up
Who cannot join
- patient has active infection or sepsis(treated or untreated) enough to compromise implant stability or postoperative recovery
- patient is a female of child-bearing age and not taking and not taking contraceptive pills
- patient has inadequate bone stock to support the device (e.g. severe osteopenia, family history of severe osteoporosis or osteopenia)
- patient has a known or suspected metal sensitivity
- patient is immuno-suppressed with disease such as AIDS or is receiving high dose of cortico-steroids.
- patient has an emotional or neurological condition that would pre-empt their ability or unwillingness to participate in the clinical evaluation including mental illness, mental retardation or drug abuse
- patient is severely overweight with a BMI>40.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Laura Stiegel, STIEGEL@ccf.org
About this study
The aim of the Study is to monitor the performance of the Signature Orthopaedics Everglade Stem, World Acetabular Cup and World Liner as a part of post-market vigilance and continuous improvement efforts.
Read the detailed description
The Objective of this Post market Clinical Follow up (PMCF) study is to collect data confirming safety, performance and clinical benefits of the Everglade Stem, World Acetabular Cup and World Liner when used for a primary total hip arthroplasty at 2 years follow-up.
This prospective follow-up series is necessary to gather data for the Everglade Stem, World Acetabular Cup and World Liner as they are recently launched to the market.
The data concerning the performance and safety of the devices are gathered in various time frames starting with pre-operative status and then includes operative, at discharge, i year post-operative and 2 year post-operative evaluations.
The revision rate of the components will be monitored as the primary objective, along with pre- and post-operative measurement of the Oxford Hip Score(OHS) patient-reported outcome measure(PROM) to quantify patient satisfaction and radiographic analysis to monitor the bony response to the implants and quantify the effectiveness of the cementless fixation.
- Conditions
- Hip Disease
- Being tested
- Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreatmentDevice
The Everglade™ Stem, is a second generation cementless blade style hip stem Forged in Titanium and proximally Antero-Posterior (AP) flared with Titanium Plasma Spray + Hydroxyapatite (TPS + HA) coated for bone on-growth.
The stem has distal geometry and a polished anodized surface finish to minimize the stem hanging in Dorr A femurs.
The World Acetabular Cup is a porous coated and mated with the Cross-linked polyethylene World Liner
What is being measured
The primary outcome is the main question the study is designed to answer.
Everglade Stem, World Cup and World Liner Survival Rate
The implant survival rate based on removal of the device for any reason as determined following the Kaplan-Meier method
Measured: upto 2 years
Secondary outcomes (1)
Oxford Hip Score (OHS)
The OHS is a patient reported outcome measure (PROM) used to quantify patient satisfaction with the treatment. The OHS consists of 12 questions scored 1 to 5 by the patient.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start22 Nov 2023
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip DiseaseStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Signature Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Cleveland Clinic
- Responsible party
- Sponsor
- Investigators
- Nicolas Piuzzi, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153940
- Sponsor's protocol ID
- 111-450-100
- Status last verified
- Nov 2023
- First submitted
- 22 Nov 2023
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Everglade Stem, World Cup and World Liner Post Market Clinical Follow-up
- ClinicalTrials.gov ID
- NCT06153940
- Acronym / sponsor ID
- 111-450-100
- Conditions
- Hip Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Signature OrthopaedicsIndustry (pharma, biotech, devices)
- Collaborators
- The Cleveland Clinic
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 1 Dec 2023 (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.
The aim of the Study is to monitor the performance of the Signature Orthopaedics Everglade Stem, World Acetabular Cup and World Liner as a part of post-market vigilance and continuous improvement efforts.
Detailed description
The Objective of this Post market Clinical Follow up (PMCF) study is to collect data confirming safety, performance and clinical benefits of the Everglade Stem, World Acetabular Cup and World Liner when used for a primary total hip arthroplasty at 2 years follow-up.
This prospective follow-up series is necessary to gather data for the Everglade Stem, World Acetabular Cup and World Liner as they are recently launched to the market.
The data concerning the performance and safety of the devices are gathered in various time frames starting with pre-operative status and then includes operative, at discharge, i year post-operative and 2 year post-operative evaluations.
The revision rate of the components will be monitored as the primary objective, along with pre- and post-operative measurement of the Oxford Hip Score(OHS) patient-reported outcome measure(PROM) to quantify patient satisfaction and radiographic analysis to monitor the bony response to the implants and quantify the effectiveness of the cementless fixation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of the Cleveland Clinic
Key inclusion criteria (4 listed)
- patient requires unilateral primary total hip arthroplasty due to non-inflammatory degenerative joint disease (e.g. osteoarthritis, traumatic arthritis, avascular necrosis, dysplasia/DDH)
- patient must be a candidate for use of the products studied, as determined jointly by the surgeon and patient
- male and non-pregnant female patients aged 18-75
- patients who understand the conditions of the clinical evaluation and are willing to participate for the length of the prescribed follow-up
Key exclusion criteria (7 listed)
- patient has active infection or sepsis(treated or untreated) enough to compromise implant stability or postoperative recovery
- patient is a female of child-bearing age and not taking and not taking contraceptive pills
- patient has inadequate bone stock to support the device (e.g. severe osteopenia, family history of severe osteoporosis or osteopenia)
- patient has a known or suspected metal sensitivity
- patient is immuno-suppressed with disease such as AIDS or is receiving high dose of cortico-steroids.
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 |
|---|---|---|
| TreatmentThe Everglade™ Stem, is a second generation cementless blade style hip stem Forged in Titanium and proximally Antero-Posterior (AP) flared with Titanium Plasma Spray + Hydroxyapatite (TPS + HA) coated for bone on-growth. The stem has distal geometry and a polished anodized surface finish to minimize the stem hanging in Dorr A femurs. The World Acetabular Cup is a porous coated and mated with the Cross-linked polyethylene World Liner | Device | – |
Primary outcome
Everglade Stem, World Cup and World Liner Survival Rate
Time frame: upto 2 years
The implant survival rate based on removal of the device for any reason as determined following the Kaplan-Meier method
1 secondary outcome
Oxford Hip Score (OHS)
Time frame: up to 2 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 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Nicolas Piuzzi, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Disease, run by Signature Orthopaedics at 1 site in United States.
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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Satish A Shejale, M.S. Orthopaedics (+61 02 9428 5181, satish.shejale@signatureortho.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Everglade Stem, World Cup and World Liner Survival Rate (time frame: upto 2 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 Dec 2023.