Origin Stem and Logical Cup Post Market Clinical Follow-up

Hip Disease Clinical Trial

Official title:

Origin Stem and Logical Cup Post Market Clinical Follow-up

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04123600
• Other study ID #: 111-201-352
• Status: Recruiting
• Start date: November 19, 2019
• Est. completion date: November 19, 2023

Study information

• Verified date: September 2021
• Source: Signature Orthopaedics
• Contact: Melody C Labrune, MS
• Phone: +61 02 9428 5181
• Email: melody.labrune[@]signatureortho.com.au
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 19, 2023
• Est. primary completion date: November 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hip Disease

Intervention

Device:
• Origin Stem and Logical Cup
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.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Signature Orthopaedics	The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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