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

Hip Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06153940
• Other study ID #: 111-450-100
• Status: Recruiting
• Start date: November 22, 2023
• Est. completion date: March 1, 2028

Study information

• Verified date: November 2023
• Source: Signature Orthopaedics
• Contact: Satish A Shejale, M.S. Orthopaedics
• Phone: +61 02 9428 5181
• Email: satish.shejale[@]signatureortho.com.au
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 1, 2028
• Est. primary completion date: March 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hip Disease

Intervention

Device:
• Treatment
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

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Signature Orthopaedics	The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Primary	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	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