Origin Stem and Logical Cup Post Market Clinical Follow-up

NCT04123600 | Unknown FDA Device

• 1 other identifier: 111-201-352
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to monitor the performance of the Signature Orthopaedics Origin Stem and Logical Acetabular Cup as part of post-market vigilance and continuous improvement efforts.

Conditions

Hip Disease

Keywords

Hip Replacement

Outcome Measures

Primary Outcomes (1)

• Stem and Cup Survival Rate

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

  up to 2 years

Secondary Outcomes (2)

• Oxford Hip Score (OHS)

  up to 2 years

• Radiographic Analysis

  up to 2 years

Interventions

Origin Stem and Logical Cup DEVICE

The Origin Stem is a straight, tapered, HA coated cementless femoral stem, and the Logical Cup is a porous coated acetabular cup mated with a cross-linked polyethylene liner. The components are used as part of a total joint replacement prosthesis.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of the Cleveland Clinic

You may qualify if:

• 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

You may not qualify if:

• patient has active infection or sepsis (treated or untreated)
• patient has any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery.
• patient is female of child-bearing age and not taking contraceptive precautions
• patient has inadequate bone stock to support the device (e.g. severe osteopenia, family history of severe osteoporosis or osteopenia)
• patient has inflammatory joint disease (e.g. rheumatoid arthritis)
• patient has known moderate to severe renal deficiency
• patient has a known or suspected metal sensitivity
• patient is immuno-suppressed with diseases such as AIDS or is receiving high dose of corticosteroids
• 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.

Sponsors & Collaborators

• Signature Orthopaedics: lead
• The Cleveland Clinic: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Study Officials

• Atul Kamath, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melody C Labrune, MS

CONTACT

+61 02 9428 5181; melody.labrune@signatureortho.com.au

Declan Brazil, PhD

CONTACT

+61 02 9428 5181; declan@signatureortho.com.au

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: October 11, 2019
• Study Start: November 19, 2019
• Primary Completion: November 19, 2023
• Study Completion: November 19, 2023
• Last Updated: September 22, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)