A Post-market Observational ORIGIN® CR Clinical Study

NCT05607966 | Recruiting

• 1 other identifier: CLIN-G-014
• Study Type: observational
• Target: 199
• Locations: 1 country
• Sites: 2

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.

Conditions

Total Knee Replacement

Keywords

ORIGIN; TKA; Prosthesis

Outcome Measures

Primary Outcomes (2)

• 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).

  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

  1 year post-procedure

Secondary Outcomes (4)

• Evaluate safety by the proportion of required revisions

  2 years post procedure

• Performance on patient satisfaction

  1- and 2-years post-procedure

• Quality of Life post-procedure measured by the Knee Society score and Knee Society function questionnaire

  1- and 2-years post-procedure

• Quality of Life post-procedure measured by the Forgotten Joint Score questionnaire

  1- and 2- years post-procedure

Interventions

ORIGIN® CR devices DEVICE

It is planned to include consecutive eligible subjects which will be treated with the ORIGIN® CR devices.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have provided consent for the collection of their data and met the protocol eligibility criteria.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Symbios Orthopedie SA: lead

Study Sites (2)

GZA Ziekenhuizen - campus Sint-Augustinus

Antwerp, 2610, Belgium

RECRUITING

AZ Voorkempen

Malle, 2390, Belgium

RECRUITING

Central Study Contacts

Bojana Gannevat

CONTACT

+41 4242626; bojana.gannevat@symbios.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 7, 2022
• Study Start: July 10, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)