Persona Revision Knee System EMEA PMCF Study

NCT07843966 | Not Yet Recruiting

• 1 other identifier: CMG2023-28K
• Study Type: observational
• Target: 238
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Severe Knee Pain; Severe Knee Disability; Revision Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Change in Oxford Knee Score (OKS) from Baseline to 2 Years

  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.

  From baseline (pre-operative assessment) to 2 years after surgery

Secondary Outcomes (6)

• All-Cause Implant Survival

  From surgery up to 10 years post-surgery

• Adverse events / Safety

  From surgery up to 10 years of follow-up

• Oxford Knee Score - follow-up beyond the primary endpoint

  Baseline, 3 months, 1 year, 2 years, 3 years (optional), 5 years, 7 years (optional), and 10 years post-surgery

• EQ-5D-5L Health Related Quality of Life

  Baseline, 3 months, 1 year, 2 years, 3 years (optional), 5 years, 7 years (optional), and 10 years post-surgery

• Patient Satisfaction with the Study Knee and Treatment

  3 months, 1 year, 2 years, 3 years (optional), 5 years, 7 years (optional), and 10 years post-surgery

Study Arms (2)

Cohort 1: Persona Revision Knee + CCK articular surface

From the total sample size (238 cases), 119 cases will be implanted with the Persona Revision Knee and the CCK articular surface.

Cohort 2: Persona Revision Knee + CPS or PS articular surface

From the total sample size (238 cases), 119 cases will be implanted with the Persona Revision Knee and CPS or PS articular surface.

Eligibility Criteria

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

Study Population

Patients undergoing revision total knee arthroplasty with the Persona Revision Knee System who meet the study eligibility criteria at participating study sites.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer, GmbH: lead

Study Sites (2)

Hvidovre University Hospital

Copenhagen, Denmark

Location

Hospital Miguel Servet

Zaragoza, Spain

Location

Study Officials

• Anders Troelsen, MD, PhD

  Hvidovre University Hospital, Copenhagen, Denmark

  PRINCIPAL INVESTIGATOR

• Fernando Martinez Delgado, MD, PhD

  Hospital Universitario Miguel Servet, Zaragoza, Spain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvina Grasso, PhD

CONTACT

0034674348191; silvina.grasso@zimmerbiomet.com

Sabine Illi

CONTACT

0041792014430; sabine.Illi@zimmerbiomet.com

Study Design

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

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 28, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): December 1, 2038
• Last Updated: September 28, 2026

Record last verified: 2026-09

Locations

DK (1); ES (1)