OsteoarthritisNCT01859130
Zimmer POLAR - Total Knee Arthroplasty (TKA)
A study testing Zimmer Persona Total Knee System in people with Osteoarthritis and RheumatoId Arthritis, run by Zimmer Biomet at 4 sites in United States.
Trial summary
The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Persona fixed bearing knee implants used in total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteoarthritis, RheumatoId Arthritis, Traumatic Arthritis
- What is being tested?
- Zimmer Persona Total Knee System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 299 participants
- Where
- 4 sitesUnited States
- Study dates
- 21 Oct 2013to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient 18-75 years of age, inclusive;
- Patient qualifies for primary total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following:
- rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis;
- collagen disorders and/or avascular necrosis of the femoral condyle;
- post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
- moderate valgus, varus, or flexion deformities;
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- the salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee;
- Patient has participated in a study-related Informed Consent process;
- Patient is willing and able to complete scheduled study procedures and follow-up evaluations;
- Independent of study participation, patient is a candidate for commercially available Persona fixed bearing knee components implanted in accordance with product labeling.
Who cannot join
- Patient is currently participating in any other surgical intervention studies or pain management studies;
- Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint;
- Insufficient bone stock on femoral or tibial surfaces;
- Skeletal immaturity;
- Neuropathic arthropathy;
- Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb;
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- Stable, painless arthrodesis in a satisfactory functional position;
- Severe instability secondary to the absence of collateral ligament integrity;
- Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin;
- Patient has a known or suspected sensitivity or allergy to one or more of the implant materials;
- Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.);
- Patient has previously received partial or total knee arthroplasty for the ipsilateral knee.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Duke University
Durham, North Carolina, 27701
The Rothman Institute
Egg Harbor, New Jersey, 08234
Midwest Orthopaedics at Rush
Naperville, Illinois, 60563
The Rothman Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: Persona Outcomes Led Assessment Research in Total Knee Arthroplasty
The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Persona fixed bearing knee implants used in total knee arthroplasty. The assessment will include implant survivorship and clinical performance measured by pain and function, quality of life data, radiographic parameters and survivorship.
Read the detailed description
The study design is a prospective, multicenter, study of the commercially available Persona fixed bearing knee implants. The study will require each site to obtain Institutional Review Board (IRB) approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process.
All study subjects will undergo preoperative clinical evaluations prior to their total knee arthroplasty. The post-operative clinical and radiographic evaluations will be conducted at 6 weeks, 6 months, 1 year, 2, 3, 4, and 5 years.
All info specified in the Brief Summary will be captured via the Knee Society Score, EQ-5D, Forgotten Joint Score, KSS Patient Expectations, Physical Exam, and Physician's Assessment of Radiographic Outcomes form.
- Being tested
- Zimmer Persona Total Knee System
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zimmer Persona Total Knee SystemDevice
Also called Primary Knee Replacement,, Total Knee Arthroplasty,, Total Knee Replacement
| Study group | Role | What they receive |
|---|---|---|
| Persona TKA | Other | Primary total knee arthroplasty subjects that receive the Zimmer Persona Total Knee System Receives: Device: Zimmer Persona Total Knee System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Society Scores
This form includes alignment, instability, joint range of motion, and symptoms. The overall range of scores available is -8 to 106. A higher score indicates good alignment, range of motion, and minimal symptoms of pain. A lower score indicates poor knee alignment, potential issues in range of motion, and the likely experience of symptoms of pain.
Measured: 5 years post op
Secondary outcomes (2)
EQ-5D
The EQ-5D family of instruments has been developed to evaluate health across a wide range of disease areas. Each EQ-5D instrument comprises a short descriptive system questionnaire and a visual analogue scale (EQ VAS). The questionnaire provides a simple descriptive profile of a respondent's health state. The EQ VAS provides an alternative way to elicit an individual's rating of the individual's own overall current health. The overall range is -0.1 to 1.0. A higher score indicates a better overall health rating reported by the patient, and a lower score indicates a poor overall health rating. It is possible to score a negative value. Although unlikely, a negative value is observed to be a state worse than death.
Measured: 5 years post op
Forgotten Joint Score (FJS)
The Forgotten Joint Score-12 (FJS-12) is a validated patient-reported outcome measure (PROM) tool designed to assess artificial prosthesis awareness during daily activities following total knee arthroplasty (TKA). Scores range from 0-100. A score of 100 would indicate a high degree of "forgetting" the artificial joint (a low degree of awareness). A score of 0 would indicates a very low degree of "forgetting" the artificial joint (typically aware of the replacement).
Measured: 5 years post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study start21 Oct 2013
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kacy Arnold, RN MBA, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01859130
- Sponsor's protocol ID
- CSU2012-10K
- Status last verified
- Oct 2023
- First submitted
- 16 May 2013
- Last updated
- 13 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persona Outcomes Led Assessment Research in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01859130
- Acronym / sponsor ID
- CSU2012-10K
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2013 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 21 May 2013 (estimated)
- Results
- Posted 13 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Persona fixed bearing knee implants used in total knee arthroplasty. The assessment will include implant survivorship and clinical performance measured by pain and function, quality of life data, radiographic parameters and survivorship.
Detailed description
The study design is a prospective, multicenter, study of the commercially available Persona fixed bearing knee implants. The study will require each site to obtain Institutional Review Board (IRB) approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process.
All study subjects will undergo preoperative clinical evaluations prior to their total knee arthroplasty. The post-operative clinical and radiographic evaluations will be conducted at 6 weeks, 6 months, 1 year, 2, 3, 4, and 5 years.
All info specified in the Brief Summary will be captured via the Knee Society Score, EQ-5D, Forgotten Joint Score, KSS Patient Expectations, Physical Exam, and Physician's Assessment of Radiographic Outcomes form.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Persona TKA | Other | Device: Zimmer Persona Total Knee SystemPrimary total knee arthroplasty subjects that receive the Zimmer Persona Total Knee System |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient 18-75 years of age, inclusive;
- Patient qualifies for primary total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following:
- Patient has participated in a study-related Informed Consent process;
- Patient is willing and able to complete scheduled study procedures and follow-up evaluations;
- Independent of study participation, patient is a candidate for commercially available Persona fixed bearing knee components implanted in accordance with product labeling.
Key exclusion criteria (12 listed)
- Patient is currently participating in any other surgical intervention studies or pain management studies;
- Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint;
- Insufficient bone stock on femoral or tibial surfaces;
- Skeletal immaturity;
- Neuropathic arthropathy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zimmer Persona Total Knee SystemAlso: Primary Knee Replacement,, Total Knee Arthroplasty,, Total Knee Replacement | Device | Persona TKA |
Primary outcome
Knee Society Scores
Time frame: 5 years post op
This form includes alignment, instability, joint range of motion, and symptoms. The overall range of scores available is -8 to 106. A higher score indicates good alignment, range of motion, and minimal symptoms of pain. A lower score indicates poor knee alignment, potential issues in range of motion, and the likely experience of symptoms of pain.
2 secondary outcomes
EQ-5D
Time frame: 5 years post op
Forgotten Joint Score (FJS)
Time frame: 5 years post-op
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kacy Arnold, RN MBA study director
Zimmer Biomet
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zimmer Persona Total Knee System in people with Osteoarthritis and RheumatoId Arthritis, run by Zimmer Biomet at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Society Scores (time frame: 5 years post op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2023.