Total Knee ReplacementNCT06628050
ORIGIN® PS Modular & Associated Instruments
An observational study of Total Knee Replacement, run by Symbios Orthopedie SA at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Total Knee Replacement
- What is being tested?
- ORIGIN® PS Modular devices
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 2 sitesFrance
- Study dates
- 18 Apr 2023to Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 16Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Polyclinique Medipole Saint Roch
Cabestany, 66330
Clinique Juge
Marseille, 13008
About this study
Official title: 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.
Read the 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.
- Conditions
- Total Knee Replacement
- Being tested
- ORIGIN® PS Modular devices
- Keywords
- TKA, ORIGIN, Prosthesis, Postero-stabilized, Modular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORIGIN® PS Modular devicesDevice
Consecutive eligible subjects have been included which have been treated with the ORIGIN® PS Modular devices.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 2 years post-op procedure
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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).
Measured: 2 years post-op procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start18 Apr 2023
- Primary completionJun 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Symbios Orthopedie SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628050
- Sponsor's protocol ID
- CLIN-G-013
- Status last verified
- Oct 2024
- First submitted
- 7 May 2024
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Observational Study of the ORIGIN® PS Modular Total Knee Prosthesis and Associated Instruments
- ClinicalTrials.gov ID
- NCT06628050
- Acronym / sponsor ID
- CLIN-G-013
- Conditions
- Total Knee Replacement
- Keywords
- TKA, ORIGIN, Prosthesis, Postero-stabilized, Modular
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Symbios Orthopedie SAIndustry (pharma, biotech, devices)
- Study start
- 18 Apr 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 4 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ORIGIN® PS Modular devicesConsecutive eligible subjects have been included which have been treated with the ORIGIN® PS Modular devices. | Device | – |
Primary outcome
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).
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.
3 secondary outcomes
Evaluate the success of the surgical procedure by means of a surgeon satisfaction questionnaire.
Time frame: Perioperative
Evaluate safety by analyzing the occurencies of adverse events.
Time frame: Perioperative and 2 years post-op procedure
Patient Quality of Life by means of the FJS score
Time frame: 2 years post-op procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Knee Replacement, run by Symbios Orthopedie SA at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate safety by the proportion of required revisions (time frame: 2 years post-op procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.