Origin Stem and Logical Cup Post Market Clinical Follow-up

• Conditions: Hip Disease

• Registration Number: NCT04123600
• Lead Sponsor: Signature Orthopaedics

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.

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 Timeline

• Study First Submitted: 2019-10-08
• Study First Submitted QC: 2019-10-09
• Study First Posted: 2019-10-11
• Study Start: 2019-11-19
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-20
• Last Update Posted: 2021-09-22
• Primary Completion: 2023-11-19
• Study Completion: 2023-11-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stem and Cup Survival Rate	up to 2 years	The implant survival rate based on removal of the device for any reason as determined following the Kaplan-Meier method.

Secondary Outcome Measures

Name	Time	Method
Oxford Hip Score (OHS)	up to 2 years	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.
Radiographic Analysis	up to 2 years	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.

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States