Everglade Stem, World Cup and World Liner Post Market Clinical Follow-up

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.

Study Overview

• Status: Recruiting
• Conditions: Hip Disease
• Intervention / Treatment: Device: Treatment

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Declan Brazil, PhD; Phone Number: +61 02 9428 5181; Email: declan@signatureortho.com.au
• Study Contact Backup: Name: Satish A Shejale, M.S. Orthopaedics; Phone Number: +61 02 9428 5181; Email: satish.shejale@signatureortho.com.au

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
      • Contact: Laura Stiegel; Email: stiegel@ccf.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients of the Cleveland Clinic

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	upto 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic Analysis	Post-operative radiographs of the implant are analysed to identify locations and sizes of radiolucency, indicative of poor fixation. The size, location and progression of radiolucencies is monitored. Smaller, non-progressive radiolucencies are preferred.	up to 2 years.

Collaborators and Investigators

• Sponsor: Signature Orthopaedics
• Collaborators: The Cleveland Clinic
• Investigators: Principal Investigator: Nicolas Piuzzi, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2023
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: November 22, 2023
• First Submitted That Met QC Criteria: November 22, 2023
• First Posted (Actual): December 1, 2023

Study Record Updates

• Last Update Posted (Actual): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 22, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 111-450-100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No