Clinical Trials in Spain / NCT07843966
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Observational
Persona Revision Knee System EMEA PMCF Study
NCT07843966 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Severe Knee PainSevere Knee DisabilityRevision Arthroplasty
Study summary
The purpose of this post-market clinical follow-up study is to confirm the long-term safety, performance and clinical benefits of the Persona Revision Knee System Implants and Instrumentation in revision Total Knee Arthroplasty.
Eligibility
Inclusion Criteria:
* Patient qualifies for a revision knee arthroplasty with the Persona Revision Knee System. Full or partial/hybrid revision cases that fall within the revision knee indication are allowed to be included in the study (not first joint replacement).
* Patient experiences severe knee pain and disability due to:
The salvage of previously failed knee surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
* One-stage revision performed for infection OR
* Second stage (reimplantation) of a planned two-stage revision.
* Patient is ≥ 18 years.
* Patient is skeletally mature.
* Patient is willing and able to complete scheduled follow-up evaluations as described in the Protocol and Informed Consent Form.
* Patient has participated in the Informed Consent process and is willing and able to sign the Informed Consent Form.
Exclusion Criteria:
* Patient received the study device for any condition not listed in the indications or in combination with a non-compatible device.
* First Knee Replacement patients.
* Patient with only inlay/bearing exchange/revision.
* Patient requires simultaneous bilateral knee surgery for treatment of diagnosed condition.
* Patient has any of the following contraindications:
* Any active or suspected latent infection in or about the knee joint or distant foci of infection which may cause hematogenous spread to the implant site: In any case, the infection needs to be treated prior to the revision surgery.
* Insufficient bone stock on femoral or tibial surfaces which cannot provide adequate support and/or fixation to the prosthesis.
* Skeletal immaturity.
* Neuropathic arthropathy.
* Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb.
* A stable, painless arthrodesis in a satisfactory functional position
* Severe instability secondary to the absence of collateral ligament integrity.
* Diagnosis of rheumatoid arthritis in conjunction with any of the following at the preoperative appointment: An ulcer of the skin, history of recurrent breakdown of the skin, use of steroids.
* Patients in whom the Persona Revision Knee System is used as a temporary, interim, spacer-type, or destination-spacer construct are not eligible, including use in a 1.5-stage revision strategy or as the first-stage construct in a planned 2-stage revision. Enrollment is restricted to subjects in whom the Persona Revision Knee System is implanted as the surgeon-intended definitive revision knee arthroplasty following infection eradication.
* Patient underwent contralateral total knee arthroplasty within 3 months of the planned index procedure or has a contralateral total knee arthroplasty planned within 3 months of the index procedure.
* Patient is known to be pregnant or planning to become pregnant during the time they will be participating in the study.
* Patient is a member of a vulnerable population group, such as
* A prisoner.
* A known alcohol or drug abuser.
* Mentally incompetent or unable to understand what participation in this study entails.
* Patient with suspected or confirmed metal sensitivity or allergy to the metals of the device.
Primary outcome measure(s)
- Change in Oxford Knee Score (OKS) from Baseline to 2 Years — From baseline (pre-operative assessment) to 2 years after surgery
Average change in Oxford Knee Score (OKS) from baseline to 2 years follow-up. The average change will be evaluated against the Minimal Clinically Important Difference (MCID) of 4.0 points.
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Hvidovre University Hospital | Copenhagen | Denmark | |
| Hospital Miguel Servet | Zaragoza | Spain |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07843966 on ClinicalTrials.gov ↗ ← All trials in Spain