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Recruiting NCT06153940

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

— Observational Hip Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Treatment.
Who it may be relevant to
Registry conditions: Hip Disease. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Everglade Stem, World Cup and World Liner Survival Rate [Time frame: upto 2 years]
Secondary outcome measures (1)
  • Oxford Hip Score (OHS) [Time frame: up to 2 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Cleveland Clinic — Cleveland

Identifiers

NCT: NCT06153940 · 111-450-100

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗