Clinical trial NCT05607966: A Post-market Observational ORIGIN® CR Clinical Study
Official title: A Post-market Observational ORIGIN® CR Clinical Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Total Knee Replacement
Keywords: ORIGIN
TKA
Prosthesis
Lead sponsor: Symbios Orthopedie SA
Sponsor class: INDUSTRY
First posted: 2022-11-07
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have provided consent for the collection of their data and met the protocol eligibility criteria.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Evaluate safety by the proportion of required revisions
timeFrame: 1 year post-procedure
measure: Evaluate performance
timeFrame: 1 year post-procedure
Secondary outcomes:
measure: Evaluate safety by the proportion of required revisions
timeFrame: 2 years post procedure
measure: Performance on patient satisfaction
timeFrame: 1- and 2-years post-procedure
measure: Quality of Life post-procedure measured by the Knee Society score and Knee Society function questionnaire
timeFrame: 1- and 2-years post-procedure
measure: Quality of Life post-procedure measured by the Forgotten Joint Score questionnaire
timeFrame: 1- and 2- years post-procedure
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: GZA Ziekenhuizen - campus Sint-Augustinus
city: Malle
country: Belgium
facility: AZ Voorkempen
Study officials:
References: