RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-12-08

Study Completion:2028-04-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06172569

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.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Satish Shejale, MS Ortho

CONTACT

+61 02 9428 5181

satish.shejale@signatureortho.com.au

Declan Brazil, PhD

CONTACT

+61 02 9428 5181

declan@signatureortho.com.au

Principal Investigator

Nicolas Piuzzi, MD

PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Study Locations (Sites)

Cleveland Clinic

Cleveland, Ohio, 44195

United States

Collaborators and Investigators

Sponsor: Signature Orthopaedics

Nicolas Piuzzi, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-08

Study Completion Date2028-04-01

Study Record Updates

Study Start Date2023-12-08

Study Completion Date2028-04-01

Terms related to this study

Additional Relevant MeSH Terms

Hip Replacement