A Post-market Observational ORIGIN® CR Clinical Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

199 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-10

Study Completion Date

2028-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

ORIGIN® PS Modular & Associated Instruments

NCT06628050

Total Knee Replacement

ACTIVE_NOT_RECRUITING

Clinical Outcome Study for the Triathlon Cruciate Retaining (CR) Total Knee

NCT02535741

Total Knee Arthroplasty

COMPLETED NA

ORIGIN® vs. VANGUARD® PS Observational Study

NCT04728542

Arthroplasty Replacement Knee

RECRUITING

A Study to Compare the NexGen CR and CR-Flex Knee Implants

NCT00761956

Total Knee Arthroplasty Osteoarthritis

COMPLETED NA

Triathlon® Cruciate Retaining (CR) Total Knee System Outcomes Study

NCT00957723

Arthroplasty, Replacement, Knee

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Total Knee Replacement

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ORIGIN® CR devices

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No