No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
380 (estimated)
Sponsor
Zimmer Biomet · Industry
Who this trial is looking for
This trial is looking for patients who have had knee surgery and need additional treatment. Participants will be evaluated for the safety and effectiveness of the Persona Revision Knee System.
Are You a Good Fit for This Trial?
Rules you outNeuropathic arthropathyOsteoporosis
You may be able to join if
I am at least 18 years old.
I have signed the consent form.
I am willing to follow study procedures and instructions.
I have been diagnosed with a knee condition requiring the Persona Revision Knee System.
I have a pre-operative Knee Society Knee Score of 80 or less.
You may not be able to join if
I have an active infection in my knee right now.
I have any infection that could affect my knee joint.
I have weak bones that cannot support the prosthesis.
I have been diagnosed with certain severe joint conditions.
I am pregnant or planning to become pregnant.
I have significant cognitive impairment.
I am institutionalized or have a drug/alcohol dependency.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The study will evaluate the performance, clinical benefits and safety of the Persona Revision Knee System in patients who have received primary or revision total knee arthroplasty (TKA) treatment. This will be done using a multicenter, single-arm, consecutive series, retrospective cohort study with prospective follow-up.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
1. Male or female of at least 18 years of age at the time of screening.
2. Signed an institutional review board approved informed consent.
3. Willingness and ability to comply with the study procedures and visit schedules and ability to understand and follow oral and written pos…
Inclusion Criteria:
1. Male or female of at least 18 years of age at the time of screening.
2. Signed an institutional review board approved informed consent.
3. Willingness and ability to comply with the study procedures and visit schedules and ability to understand and follow oral and written post-operative care instructions.
4. Previous medical diagnosis/ history of at least one of the following conditions requiring treatment using the Persona Revision Knee System within a pre-specified study variant configuration (cohort), in accordance with the instructions for use (IFU):
1. Rheumatoid arthritis, osteoarthritis, traumatic arthritis or polyarthritis
2. Collagen disorders, and/or avascular necrosis of the femoral condyle
3. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
4. Moderate valgus, varus, or flexion deformities
5. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery
5. A pre-operative Knee Society Knee Score (objective assessment) ≤ 80.
Exclusion Criteria:
1\) Presence of clinically observed active or suspected latent infection in the affected joint at the time of procedure.
3\) Presence of of local/systemic/distant focal infection that may affect or hematogenously spread to the prosthetic joint.
4\) Skeletal immaturity or insufficient bone stock on femoral or tibial surfaces which cannot provide adequate support and/or fixation to the prosthesis.
5\) Diagnosed with neuropathic arthropathy, osteoporosis, or any loss of musculature or neuromuscular disease that compromises the affected limb.
6\) Presence of a stable, painless arthrodesis in a satisfactory functional position in the affected joint.
7\) Severe instability of the affected joint secondary to the absence of collateral ligament integrity.
8\) Diagnosis of rheumatoid arthritis in conjunction with any of the following at the time of screening:
1. An ulcer of the skin
2. History of recurrent breakdown of the skin
3. Use of steroids
9\) Patient requires simultaneous bilateral knee surgery for treatment of diagnosed condition.
10\) Pregnant or women planning to become pregnant during the time they will be participating in the study.
11\) Any documented clinically significant degree of cognitive impairment or other condition, finding, or psychiatric illness at screening which, in the opinion of the Investigator, could compromise patient safety or interfere with the assessment of the safety and treatment effects of the study procedure.
12\) Any patient who is institutionalized, or with a known drug or alcohol dependence currently or within the last year.
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