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

Signature Orthopaedics

Status: Enrolling

Conditions: Hip Replacement

Treatments: Device: Spartan Stem, World Acetabular Cup and World Liner

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06172569

111-440-100

Details and patient eligibility

About

The aim of the study is to monitor the performance of the Signature Orthopaedics Spartan Stem, World Acetabular Cup and World Liner as a post-market vigilance and continuous improvement efforts.

Full description

The objective of this PMCF Study is to collect data confirming safety, performance and clinical benefits of the Spartan Stem, World Acetabular Cup and the World Liner when used for primary total hip arthroplasty at 2-years follow-up.

The study includes pre-operative, operative, discharge, 1 year post-operative evaluations, where data concerning the performance and safety of the device are gathered.

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.

Radiography analysis will be done to monitor bony response to the implant and qualify the effectiveness of the cementless fixation.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.