Total Knee ReplacementNCT05607966
A Post-market Observational ORIGIN® CR Clinical Study
An observational study of Total Knee Replacement, run by Symbios Orthopedie SA at 2 sites in Belgium.
Trial summary
The study objective is to evaluate safety and performance of the ORIGIN® CR (cruciate retaining) 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® CR devices
- Type of treatment
- Medical device
- How many people
- 199 participants
- Where
- 2 sitesBelgium
- Study dates
- 10 Jul 2024to Feb 2028
- 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.
Who may be able to join
- Male and female over 18 years of age
- Each patient who is willing to give informed consent.
- Clinically indicated for a total knee replacement
- Females who are not pregnant and not planning to become pregnant ≤ 12 months. A pregnancy test should be performed for women of childbearing age
- Geographically stable and willing to return to the implanting site for all follow-up visits at 1 year and 2 years.
Who cannot join
- 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 (requiring a femoral and/or a tibial stem and/or a thick insert)
- Any concomitant condition likely to affect implant integration or function
- Allergy or hypersensitivity to any of the materials used
- For devices in CoCrMo (ISO 5832/4): renal and hepatic impairment
Show all 16Show fewer
- Hip Knee Ankle (HKA) angle < 165° or > 195°
- Severe collateral ligaments deficiency (requiring a more constrained prosthesis)
- Posterior cruciate ligament deficiency
- Major anatomical deformities
- Severe flexion contracture or severe recurvatum
- Revision of a partial or total knee prosthesis
- Non-extractible material (e.g. screws, 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. Contact the study team or a site near you to ask about taking part.
Belgium2 sites, 2 recruiting
- Recruiting
GZA Ziekenhuizen - campus Sint-Augustinus
Antwerp, 2610
Bart Stuyts, Dr., +32 3 443 48 11, bart.stuyts@emmaus.be
- Recruiting
AZ Voorkempen
Malle, 2390
Bart Stuyts, Dr., +32 3 443 48 11, bart.stuyts@emmaus.be
About this study
The study objective is to evaluate safety and performance of the ORIGIN® CR (cruciate retaining) devices and associated instruments, more precisely to evaluate safety by the proportion of patients requiring a revision (i.e. revision rate) at 1-year post procedure and to evaluate performance by means of a Knee Society Score (KSS) Knee Score at 1 year post procedure and by means of a KSS Function Score also at 1 year 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® CR.
Read the detailed description
The study is a prospective, non-comparative, non-randomized, single-arm, observational, post market study in which 199 patients will be enrolled to evaluate the safety and performance of the ORIGIN® CR 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® CR devices
- Keywords
- ORIGIN, TKA, Prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORIGIN® CR devicesDevice
It is planned to include consecutive eligible subjects which will be treated with the ORIGIN® CR 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 after 1-year post-procedure. 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: 1 year post-procedure
Evaluate performance
Evaluate performance by means of following questionnaires: Knee Society Score (KSS) and a Knee Society Function score, a partient-reported outcome measure.
The KSS contains questions in 2 sections: knee joint (pain, range of motion, stability) and function (walking distance, ability to climb stairs). When calculating the score, deductions are taken for assistive devices and flexion contractures, misalignment, or extension lag. The maximum points which can be reached are 100 points.
- Clinical status assessed by means of the KSS Knee score at 1 year post procedure
- Clinical status assessed by means of the KSS Function score at 1 year post procedure
Measured: 1 year post-procedure
Secondary outcomes (4)
Evaluate safety by the proportion of required revisions
Proportion of patients requiring a revision after 2 years post-procedure.
Measured: 2 years post procedure
Performance on patient satisfaction
Patient satisfaction questionnaires at 1 year and 2 years follow-up visits.
Measured: 1- and 2-years post-procedure
Quality of Life post-procedure measured by the Knee Society score and Knee Society function questionnaire
Quality of Life measured by means of the Knee Society score and Knee Society function score questionnaires at 1- and 2-years follow-up visit.
Measured: 1- and 2-years post-procedure
Quality of Life post-procedure measured by the Forgotten Joint Score questionnaire
Quality of Life measured by means of the Forgotten Joint Score questionnaire at 1- and 2-years follow-up visit.
12 questions refer to how aware the patients are of their artificial hip/knee joint in everyday life
Scoring: For scoring the FJS-12, all responses are summed (never, 0 points; almost never, 1 point; seldom, 2 points; sometimes, 3 points; mostly, 4 points) and then divided by the number of completed items. This mean value is subsequently multiplied by 25 to obtain a total score range of 0 to 100.
Finally, the score is subtracted from 100, to change the direction of the final score in a way that high scores indicate a high degree of "forgetting" the artificial joint, that is, a low degree of awareness.
If more than 4 responses are missing, the total score should not be used.
Measured: 1- and 2- years post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start10 Jul 2024
- Primary completionNov 2027 (estimated)
- Study completionFeb 2028 (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
- Prospective
- Enrolment
- 199 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Symbios Orthopedie SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05607966
- Sponsor's protocol ID
- CLIN-G-014
- Status last verified
- Oct 2024
- First submitted
- 27 Oct 2022
- Last updated
- 8 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 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-market Observational ORIGIN® CR Clinical Study
- ClinicalTrials.gov ID
- NCT05607966
- Acronym / sponsor ID
- CLIN-G-014
- Conditions
- Total Knee Replacement
- Keywords
- ORIGIN, TKA, Prosthesis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 199 participants (estimated)
- Lead sponsor
- Symbios Orthopedie SAIndustry (pharma, biotech, devices)
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 7 Nov 2022 (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® CR (cruciate retaining) devices and associated instruments, more precisely to evaluate safety by the proportion of patients requiring a revision (i.e. revision rate) at 1-year post procedure and to evaluate performance by means of a Knee Society Score (KSS) Knee Score at 1 year post procedure and by means of a KSS Function Score also at 1 year 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® CR.
Detailed description
The study is a prospective, non-comparative, non-randomized, single-arm, observational, post market study in which 199 patients will be enrolled to evaluate the safety and performance of the ORIGIN® CR 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
- Prospective
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.
Key inclusion criteria (5 listed)
- Male and female over 18 years of age
- Each patient who is willing to give informed consent.
- Clinically indicated for a total knee replacement
- Females who are not pregnant and not planning to become pregnant ≤ 12 months. A pregnancy test should be performed for women of childbearing age
- Geographically stable and willing to return to the implanting site for all follow-up visits at 1 year and 2 years.
Key exclusion criteria (16 listed)
- 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 (requiring a femoral and/or a tibial stem and/or a thick insert)
- Any concomitant condition likely to affect implant integration or function
- Allergy or hypersensitivity to any of the materials used
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® CR devicesIt is planned to include consecutive eligible subjects which will be treated with the ORIGIN® CR devices. | Device | – |
Primary outcome
Evaluate safety by the proportion of required revisions
Time frame: 1 year post-procedure
Proportion of patients requiring a revision after 1-year post-procedure. 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: 1 year post-procedure
Evaluate performance by means of following questionnaires: Knee Society Score (KSS) and a Knee Society Function score, a partient-reported outcome measure. The KSS contains questions in 2 sections: knee joint (pain, range of motion, stability) and function (walking distance, ability to climb stairs). When calculating the score, deductions are taken for assistive devices and flexion contractures, misalignment, or extension lag. The maximum points which can be reached are 100 points. * Clinical status assessed by means of the KSS Knee score at 1 year post procedure * Clinical status assessed by means of the KSS Function score at 1 year post procedure
4 secondary outcomes
Evaluate safety by the proportion of required revisions
Time frame: 2 years post procedure
Performance on patient satisfaction
Time frame: 1- and 2-years post-procedure
Quality of Life post-procedure measured by the Knee Society score and Knee Society function questionnaire
Time frame: 1- and 2-years post-procedure
Quality of Life post-procedure measured by the Forgotten Joint Score questionnaire
Time frame: 1- and 2- years post-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 8 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.
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 Belgium.
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 5 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: looking for participants now, as of the sponsor's last update on 8 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 Belgium. 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?
Contact Bojana Gannevat (+41 4242626, bojana.gannevat@symbios.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate safety by the proportion of required revisions (time frame: 1 year post-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 8 Oct 2024.