ORIGIN® PS Modular & Associated Instruments

October 3, 2024 updated by: Symbios Orthopedie SA

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluate safety by the proportion of required revisions
Time Frame: 2 years post-op procedure
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
Time Frame: 2 years post-op procedure

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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluate the success of the surgical procedure by means of a surgeon satisfaction questionnaire.
Time Frame: Perioperative
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.
Time Frame: Perioperative and 2 years post-op procedure
  • 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
Time Frame: 2 years post-op procedure
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Symbios Orthopedie SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 18, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 4, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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