A Post-market Observational ORIGIN vs. VANGUARD PS Clinical Study

  • STATUS
    Recruiting
  • End date
    Nov 16, 2024
  • participants needed
    140
  • sponsor
    Symbios Orthopedie SA
Updated on 16 August 2021

Summary

The study objective is to assess patient satisfaction after the surgery with a custom-made CE marked implant (ORIGIN) versus off-the-shelf (VANGUARD PS) device, and to document the clinical and device performance outcomes of the ORIGIN System used in routine hospital practice in a large patient cohort treatment of total knee arthroplasty.

The hypothesis is that patients receiving ORIGIN implants will experience a more natural feel of the prosthesis during the first year after the surgery compared to patients receiving VANGUARD implants (as measured with FJS), 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. It is also supposed that the overall patient satisfaction is expected to be higher with ORIGIN PS than with VANGUARD PS treatment.

Description

ORIGIN PS and VANGUARD PS are total knee prostheses, intended to be used in primary Total Knee Replacement Arthroplasty (TKA). With the ORIGIN PS implant being customized individually made (CIM) fitting a patient's anatomy, a more natural reconstruction of knee kinematics is anticipated and ultimately a higher patient satisfaction and lower revision rate are envisioned. To date literature providing data about CIM TKA is still scarce. A study assessing kinematics after TKA found that CIM TKA more closely resembled natural knee kinematics when compared to standard off-the-shelf (OTS) TKA. This resemblance allows for a more natural femoral rollback during knee flexion, the authors found. CIM TKA demonstrates knee kinematics more similar to a normal knee studying tibiofemoral kinematics using mobile fluoroscopy in vivo. Furthermore, CIM TKA has shown to provide a more accurate tibial fit and rotation, when compared to several standard TKA.

A retrospective review of 621 TKA patients, 307 with CIM TKA and 314 with conventional implants, demonstrated a decreased estimated blood loss, decreased length of stay, decreased range of motion, and no discernible difference in surgical or tourniquet time. Albeit, the differences found were not deemed clinically relevant, the study underlined the safety and efficacy of the CIM TKA technique. Patients who received CIM TKA had lower transfusion rates and fewer adverse events.

Four year data from the UK National Joint Registry showed a cumulative percent revision rate of 0.5% for CIM TKA versus a cumulative percent revision rate of 1.9% for all TKA.

While all this data is encouraging, randomized controlled studies and assessments of patient reported outcomes are missing. Therefore, the current study aims to close this knowledge gap and provide Level I evidence for CIM TKA by comparing the two TKA Prostheses mentioned above and to evaluate their clinical performance and safety.

This is a prospective, comparative, randomized, double arm, monocentric, observational, post-market study. The study is performed in Germany, in the University Medical Center of Johannes Gutenberg-University Mainz (UMC-Mainz).

It is stated that 140 subjects implanted with either the ORIGIN PS or VANGUARD PS System will be included upon eligibility assessment. Subjects will be followed at one and two years after the procedure.

Enrollment will occur at the time of the medical examination. It is assumed that the subjects' treatments and follow-up visits will be performed per standard of the investigational site in Germany.

It is anticipated that enrollment will take approximately 18 months. As each implanted subject is to be followed for two years, the estimated study duration is approximately 48 months, excluding the time required for preparing the final report. (A loss of approximately 10% is expected at the end of the study)

Details
Condition Arthroplasty, Knee joint, Knee, Reimplantation, reimplantation procedure, replacement procedure, re-implantation, joint arthroplasty, joint reconstruction, arthroplasties
Treatment ORIGIN PS System, VANGUARD PS System
Clinical Study IdentifierNCT04728542
SponsorSymbios Orthopedie SA
Last Modified on16 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male and female over 18 years of age
Each patient, or his or her guardian or legal representative, is willing to give informed consent
Clinically indicated for a total Knee replacement
Females who are not pregnant or lactating and not planning to become pregnant 12 months. A pregnancy test may be performed to confirm this
Geographically stable and willing to return to the implanting site for all follow-up visits at 1 year and 2 years

Exclusion Criteria

Life expectancy 1 year
Age 80 years
Acute or chronic, local or systemic infection
Mental illness
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
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