Clinical trial NCT06628050: ORIGIN® PS Modular & Associated Instruments
Official title: Post-market Observational Study of the ORIGIN® PS Modular Total Knee Prosthesis and Associated Instruments
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Total Knee Replacement
Keywords: TKA
ORIGIN
Prosthesis
Postero-stabilized
Modular
Lead sponsor: Symbios Orthopedie SA
Sponsor class: INDUSTRY
First posted: 2024-10-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluate safety by the proportion of required revisions
timeFrame: 2 years post-op procedure
measure: Evaluate performance
timeFrame: 2 years post-op procedure
Secondary outcomes:
measure: Evaluate the success of the surgical procedure by means of a surgeon satisfaction questionnaire.
timeFrame: Perioperative
measure: Evaluate safety by analyzing the occurencies of adverse events.
timeFrame: Perioperative and 2 years post-op procedure
measure: Patient Quality of Life by means of the FJS score
timeFrame: 2 years post-op procedure
Other outcomes:
Locations:
city: Cabestany
country: France
facility: Polyclinique Medipole Saint Roch
city: Marseille
country: France
facility: Clinique Juge
Study officials:
References: