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Recruiting NCT05607966

A Post-market Observational ORIGIN® CR Clinical Study

— Observational Total Knee Replacement

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ORIGIN® CR devices.
Who it may be relevant to
Registry conditions: Total Knee Replacement. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Evaluate safety by the proportion of required revisions [Time frame: 1 year post-procedure]
  • Evaluate performance [Time frame: 1 year post-procedure]
Secondary outcome measures (4)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Belgium · 2 centers
  • GZA Ziekenhuizen - campus Sint-Augustinus — Antwerp
  • AZ Voorkempen — Malle

Identifiers

NCT: NCT05607966 · CLIN-G-014

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗