Recruiting

Everglade Stem

Sponsor:

Signature Orthopaedics

Code:

NCT06153940

Conditions

Hip Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Treatment

Study Details

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

Study ID

NCT06153940

Start date

Nov 22, 2023

Status verified date

Nov, 2023

Completion date

Mar 1, 2028

Anticipated

Primary completion date

Mar 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Interventions

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

Primary outcome measure

  • Everglade Stem, World Cup and World Liner Survival Rate [ Time Frame: upto 2 years ]

Central Contacts and Locations

Central contacts

Satish A Shejale, M.S. Orthopaedics

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

Declan Brazil, PhD

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

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Laura Stiegel

STIEGEL@ccf.org

More Information

Sponsor

Signature Orthopaedics

Last update posted

Dec 1, 2023

Last verified

Nov, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Signature Orthopaedics on 2023-12-01.