Origin Stem and Logical Cup Post Market Clinical Follow-up

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.

Study Overview

• Status: Recruiting
• Conditions: Hip Disease
• Intervention / Treatment: Device: Origin Stem and Logical Cup

Detailed Description

The objective of this PMCF study is to collect data confirming safety, performance and clinical benefits of the Origin Stem and Logical Cup when used for primary total hip arthroplasty at 2 years follow-up. This prospective follow-up series is necessary to obtain data specific to the Origin Stem and Logical Cup considering their relatively recent launch to the market.

The study includes pre-operative, operative, discharge, 1 year post-operative and 2 year post-operative evaluations, where data concerning the performance and safety of the device are gathered. In particular, 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, and radiographic analysis to monitor bony response to the implant and qualify the effectiveness of the cementless fixation.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Melody C Labrune, MS; Phone Number: +61 02 9428 5181; Email: melody.labrune@signatureortho.com.au
• Study Contact Backup: Name: Declan Brazil, PhD; Phone Number: +61 02 9428 5181; Email: declan@signatureortho.com.au

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
      • Contact: Laura Stiegel; Email: stiegel@ccf.org
      • Principal Investigator: Atul Kamath, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients of the Cleveland Clinic

Description

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)
• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxford Hip Score (OHS)	The OHS is a patient reported outcome measure (PROM) used to quantify patient satisfaction with the treatment, consisting of 12 questions scored 1 to 5 by the patient.	up to 2 years
Radiographic Analysis	Post-operative radiographs of the implant are analysed to identify locations and sizes of radiolucencies, indicative of poor fixation. The size, location and progression of radiolucencies is monitored. Smaller, non-progressive radiolucencies are preferred.	up to 2 years

Collaborators and Investigators

• Sponsor: Signature Orthopaedics
• Collaborators: The Cleveland Clinic
• Investigators: Principal Investigator: Atul Kamath, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2019
• Primary Completion (Anticipated): November 19, 2023
• Study Completion (Anticipated): November 19, 2023

Study Registration Dates

• First Submitted: October 8, 2019
• First Submitted That Met QC Criteria: October 9, 2019
• First Posted (Actual): October 11, 2019

Study Record Updates

• Last Update Posted (Actual): September 22, 2021
• Last Update Submitted That Met QC Criteria: September 20, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Hip Replacement
• Other Study ID Numbers: 111-201-352

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No