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Observational Study of Spartan Stem, World Cup, and World Liner for Hip Replacement

This study is observing the performance of specific hip replacement parts: the Spartan Stem, World Acetabular Cup, and World Liner. These devices are used in total hip arthroplasty (hip replacement surgery). Researchers want to see how well these components work and how safe they are for patients over time. They will be looking at how long the parts last and how satisfied patients are with their new hip. You might be able to join if you are between 18 and 75 years old and need a primary total hip replacement due to conditions like osteoarthritis. The study aims to enroll 200 participants, but the current recruitment status is unclear.

Study design
This is an observational study, meaning researchers will watch how the devices perform in patients. It plans to enroll 200 participants.
What's involved
You would have pre-operative, operative, discharge, and 1-year post-operative evaluations. Data on device performance and safety will be collected during these visits.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 2 years to measure the survival rate of the components.

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NCT06172569

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

Recruiting
Not specifiedAges 18–75Observational
Signature Orthopaedics
~200 participants
Updated 2023-12-15 on ClinicalTrials.gov
What's tested:Spartan Stem, World Acetabular Cup and World Liner

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Spartan Stem, World Acetabular Cup and World Liner Survival Rate
Measured over up to 2 years

Conditions

Hip Replacement

Explore related trials

Hip Replacement

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 Shejale, MS Ortho
[email protected]
+61 02 9428 5181
Email the study team

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Do you actually qualify for this trial?

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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

  • Spartan Stem, World Acetabular Cup and World Liner Survival Rateup to 2 years

    The implant survival rate is based on removal of the device for any reason as determined following the Kaplan-Meier method.