ORIGIN® PS Modular & Associated Instruments

Post-market Observational Study of the ORIGIN® PS Modular Total Knee Prosthesis and Associated Instruments

The study objective is to evaluate safety and performance of the ORIGIN® PS (postero-stabilized) Modular devices and associated instruments, more precisely to evaluate safety by the proportion of patients requiring a revision (i.e. revision rate) at 2-6 months, 1y and 2y post-procedure and to evaluate performance by means of a Knee Society Score (KSS) Score at 2-6 months, 1y and 2y post procedure.

The hypothesis raised for this study, regarding the scoring, is that patients will experience a marked improvement in the natural feel of the prosthesis during the first year after the surgery, and slightly significant improvement at the following interval of 2 years. The overall patient satisfaction is expected to be improved after 2 years follow-up with ORIGIN® PS Modular.

Study Overview

• Status: Active, not recruiting
• Conditions: Total Knee Replacement
• Intervention / Treatment: Device: ORIGIN® PS Modular devices

Detailed Description

The study is ambispective, post market, non-comparative, non-randomized, multicentric and observational in which 200 patients will be enrolled to evaluate the safety and performance of the ORIGIN® PS Modular devices and associated instruments.

Patients will be included in the study during 18 months (inclusion window) and followed-up for 24 months.

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

Contacts and Locations

Study Locations

• France
  • Cabestany, France, 66330
    • Polyclinique Medipole Saint Roch
  • Marseille, France, 13008
    • Clinique Juge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who have provided consent for the collection of their data and met the protocol eligibility criteria will be enrolled into this observational non-comparative ambispective multicentric study.

Description

Inclusion Criteria:

• Male or female over 18 years of age.
• Patient, or if applicable, his or her guardian or legal representative, willing to give informed consent.
• Clinically indicated for first intention total knee replacement.
• Geographically stable and willing to return for all follow-up visits or, at a minimum, to complete the patient self-report score.

Exclusion Criteria:

• Vulnerable subject (as defined in ISO-14155)
• Acute or chronic, local or systemic infection,
• Muscular, ligamental, neurological, psychological or vascular deficits,
• Bone destruction or poor bone quality likely to affect implant stability.
• Any concomitant condition likely to affect implant integration or function,
• Allergy or hypersensitivity to any of the materials used,
• For devices in CoCr Mo (ISO 5832/4): renal and hepatic impairment,
• Hip Knee Ankle (HKA) angle < 165° or > 195°,
• Severe collateral ligament deficiency (requiring a more constrained prosthesis),
• Major anatomical deformities,
• Severe flexion contracture or severe recurvatum,
• Revision of a partial or total knee prosthesis,
• Non-extractible material (e.g., screw, plate, intramedullary nail, osteosynthesis material) which can create a conflict with any component of the prosthesis,
• Distal and/or posterior and/or anterior femoral bone loss which exceeds the femoral component thickness,
• Proximal tibial bone loss which exceeds the tibial component thickness (tibial tray + tibial insert),
• Bone degradation requiring an anchoring stem for femoral component

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate safety by the proportion of required revisions	Proportion of patients requiring a revision at each follow-up visit (surgery, 2-6 months, 1- and 2 years). The revision rate is consistent with the state of the art - Orthopaedic Data Evaluation Panel (ODEP) benchmark system (revision rate not higher than 2.5% to 3.5% at 1 year, 4% to 6% at 5 years and 5% to 7% at 10 years).	2 years post-op procedure
Evaluate performance	Evaluate performance by means of a Knee Society Score (KSS) and a KSS Function score. It aims to reach a KSS Knee score of at least 85,5 / 100 points and a KSS Function score of at least 72,5 / 100 points.	2 years post-op procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the success of the surgical procedure by means of a surgeon satisfaction questionnaire.	Surgeon satisfaction: during surgery, the surgeon will assess safety and performance of the associated Instrumentation and implants. The criteria of evaluation of the satisfaction are: Very satisfied - satisfied - unsatisfied - very unsatisfied. Each surgical step is evaluated for each instrument and implant component used by the surgeon. These data will be collected in the case report form based on surgeon satisfaction questionnaire and will be used in clinical evaluation of ORIGIN® PS Modular.	Perioperative
Evaluate safety by analyzing the occurencies of adverse events.	Evaluate the intraoperative difficulties and complications (the rate should not be higher than 1,8% according to the state of the art).; Evaluate post-operative complications during the entire study period.; Evaluate the safety of the modular tibial stem by analysing the revision rate for aseptic tibial loosening at each follow-up visit (surgery, 2-6 months, 1 year and 2 years) with a maximum revision rate for aseptic loosening of 5.3% for first intention total knee replacements as cited in the knee joint registries.	Perioperative and 2 years post-op procedure
Patient Quality of Life by means of the FJS score	Assess patients' ability to forget their knee in the short term after surgery, as measured by the "Forgotten Knee Score" (FJS-12: from 0 to 100 points, meaning that "0" is worst case and "100" the best).	2 years post-op procedure

Collaborators and Investigators

• Sponsor: Symbios Orthopedie SA

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: May 7, 2024
• First Submitted That Met QC Criteria: October 3, 2024
• First Posted (Actual): October 4, 2024

Study Record Updates

• Last Update Posted (Actual): October 4, 2024
• Last Update Submitted That Met QC Criteria: October 3, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Prosthesis; TKA; ORIGIN; Postero-stabilized; Modular
• Other Study ID Numbers: CLIN-G-013

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: No