ORIGIN® PS Modular & Associated Instruments

NCT06628050 | Active Not Recruiting

• 1 other identifier: CLIN-G-013
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Total Knee Replacement

Keywords

TKA; ORIGIN; Prosthesis; Postero-stabilized; Modular

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Evaluate the success of the surgical procedure by means of a surgeon satisfaction questionnaire.

  Perioperative

• Evaluate safety by analyzing the occurencies of adverse events.

  Perioperative and 2 years post-op procedure

• Patient Quality of Life by means of the FJS score

  2 years post-op procedure

Interventions

ORIGIN® PS Modular devices DEVICE

Consecutive eligible subjects have been included which have been treated with the ORIGIN® PS Modular devices.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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),

Sponsors & Collaborators

• Symbios Orthopedie SA: lead

Study Sites (2)

Polyclinique Medipole Saint Roch

Cabestany, 66330, France

Location

Clinique Juge

Marseille, 13008, France

Location

Study Design

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

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: October 4, 2024
• Study Start: April 18, 2023
• Primary Completion: June 1, 2025
• Study Completion: September 1, 2025
• Last Updated: October 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)