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

Description

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.

Conditions

Hip Replacement

Study Overview

Study Details

Study overview

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.

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

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

Condition
Hip Replacement
Intervention / Treatment

-

Contacts and Locations

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Signature Orthopaedics,

Nicolas Piuzzi, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

2028-04-01