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

Last updated: December 7, 2023
Sponsor: Signature Orthopaedics
Overall Status: Active - Recruiting

Phase

N/A

Condition

Orthopedic Surgery

Hip Replacement

Treatment

Spartan Stem, World Acetabular Cup and World Liner

Clinical Study ID

NCT06172569
111-440-100
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • patient requires unilateral primary total hip arthroplasty due to non-inflammatorydegenerative joint disease (e.g., osteoarthritis, traumatic arthritis, avascularnecrosis, dysplasia/DDH)
  • patient must be a candidate for use of the products studied, as determined jointly bythe surgeon and patient.
  • male and non-pregnant female patients aged 18-75
  • patients who understand the conditions of the clinical evaluation and are willing toparticipate for the length of the prescribed follow-up.

Exclusion

Exclusion Criteria:

  • patient has active infection or sepsis(treated or untreated) enough to compromiseimplant stability or postoperative recovery
  • patient is a female of child-bearing age and not taking and not taking contraceptivepills
  • 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 ofcortico-steroids.
  • patient has an emotional or neurological condition that would pre-empt their abilityor 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

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Spartan Stem, World Acetabular Cup and World Liner
Phase:
Study Start date:
December 08, 2023
Estimated Completion Date:
April 01, 2028

Study 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.

Connect with a study center

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

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