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

This study is observing the performance of the Everglade™ Stem, World Acetabular Cup, and World Liner, which are hip replacement parts. These devices are made of titanium and are designed to help bone grow onto them. The study aims to see how well these parts work and how safe they are for people who have a total hip replacement due to conditions like osteoarthritis. You may be able to join if you are between 18 and 75 years old, need a hip replacement, and your doctor thinks these specific devices are suitable for you. The main goal is to track how long these hip replacement parts last, especially over two years, and to measure patient satisfaction and how the bone responds to the implants. The study status is currently unclear.

Study design: This is an observational study with a planned enrollment of 200 participants. It is designed to follow participants over time to collect data.
What's involved: You will have evaluations before surgery, at discharge, and then at 1 year and 2 years after your hip replacement surgery. These evaluations will include patient satisfaction surveys and X-rays.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed for up to 2 years after their hip replacement surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting

Not specifiedAges 18–75Observational

Signature Orthopaedics

~200 participants

Updated 2023-12-01 on ClinicalTrials.gov

What's tested:Treatment

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Everglade Stem, World Cup and World Liner Survival Rate

Measured over upto 2 years

Conditions

Hip Disease

Where it's being run

1 sites across 1 states

Ohio1

Study leadership

Nicolas Piuzzi, MD · PRINCIPAL_INVESTIGATOR · The Cleveland Clinic

Who to contact

Satish A Shejale, M.S. Orthopaedics

[email protected]

+61 02 9428 5181

Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime

Eligibility criteria

Inclusion

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

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.

What this trial measures

Everglade Stem, World Cup and World Liner Survival Rateupto 2 years
The implant survival rate based on removal of the device for any reason as determined following the Kaplan-Meier method

Trialytics