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

NCT06153940 | Recruiting FDA Device

• 1 other identifier: 111-450-100
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hip Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Oxford Hip Score (OHS)

  up to 2 years

Other Outcomes (1)

• Radiographic Analysis

  up to 2 years.

Interventions

Treatment DEVICE

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of the Cleveland Clinic

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Signature Orthopaedics: lead
• The Cleveland Clinic: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Interventions

Therapeutics

Study Officials

• Nicolas Piuzzi, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Satish A Shejale, M.S. Orthopaedics

CONTACT

+61 02 9428 5181; satish.shejale@signatureortho.com.au

Declan Brazil, PhD

CONTACT

+61 02 9428 5181; declan@signatureortho.com.au

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 1, 2023
• Study Start: November 22, 2023
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)