Knee OsteoarthritisNCT05038670
Journey II vs Persona Knee Systems - RCT
A study testing Total Knee Replacement in people with Knee Osteoarthritis, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
This study compares and evaluates differences in patient-reported outcome, survivorship and radiological analysis between patients undergoing total knee arthroplasty with use of either Zimmer Biomet PERSONA Posterior Stabilized (PS) system and Smith\&Nephew Journey II Bi-Cruciate Stabilized (BCS) system Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Total Knee Replacement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 sitePoland
- Study dates
- 1 Oct 2018to 24 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Listed for a primary total knee replacement (TKR) at the Orthopaedic and Rehabilitation Department Medical University of Warsaw
- Indication for the TKR is primary osteoarthritis of the knee joint involving one or more compartments
- Aged 18 or over
- Patient willing to provide full informed consent to the trial
Who cannot join
- Listed for a single-stage bilateral TKR procedure
- Severe symptoms in the contralateral knee so as to require staged bilateral knee replacements within 6 months of the primary procedure
- Fixed flexion deformity of 15 degrees or greater who will require excessive resection of the distal femur
- Clinically assessed uncorrectable varus/valgus deformity of 15 degrees or greater
- Any co-morbidity which, in the opinion of the investigator, is severe enough to present an unacceptable risk to the patient's safety
- Inflammatory arthritis
Show all 14Show fewer
- Previous septic arthritis in the affected knee joint
- Previous surgery to the collateral ligaments of the affected knee
- Patients on warfarin or novel oral anticoagulants (NOACs)
- Will not be resident in the catchment area for at least 6 months post-surgery
- Undertaking the surgery as a private patient
- Patients who, in the opinion of the clinical staff, do not have capacity to consent
- Patients who are pregnant
- Unable to understand written and spoken Polish
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Othopedics and Rehabilitation, Medical University of Warsaw
Warsaw, Masovian Voivodeship, 04-749
About this study
Official title: Comparison of Patients-reported Outcome After Total Knee Arthroplasty With Use of Bi-cruciate Stabilized and Personalized Implant Design - Randomized Controlled Trial
This study compares and evaluates differences in patient-reported outcome, survivorship and radiological analysis between patients undergoing total knee arthroplasty with use of either Zimmer Biomet PERSONA Posterior Stabilized (PS) system and Smith\&Nephew Journey II Bi-Cruciate Stabilized (BCS) system
Read the detailed description
The aim of this study is to assess patient-reported outcome, survivorship and radiological analysis in patients after total knee arthroplasty, who will undergo the surgery with the use of either Zimmer Biomet PERSONA Posterior Stabilized (PS) system and Smith\&Nephew Journey II Bi-Cruciate Stabilized (BCS) system.
To this study 45 consecutive patients undergoing total knee arthroplasty will be recruited to each group. Study protocol is designed as a prospective, blinded, parallel-group, superiority trial, with balanced randomization [1:1]. All participants will be operated in single clinical orthopedic department, by single high-volume surgeon, who performed more than 3000 total knee arthroplasties in his professional career.
Before the surgery patients will fulfill the author's questionnaire concerning their age, height and body mass, level of activity, WOMAC and KOOS scales.
1-day posteoperatively patients will undergo standard computed tomography examination to assess components placement
- Conditions
- Knee Osteoarthritis
- Being tested
- Total Knee Replacement
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Knee ReplacementDevice
Participant will undergo total knee replacement performed via anterior parapatellar approach with either PERSONA PS or JOURNEY II BCS
| Study group | Role | What they receive |
|---|---|---|
| PERSONA | Active comparator | Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet PERSONA system Receives: Device: Total Knee Replacement |
| Journey II | Active comparator | Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Smith\&Nephew Journey II system Receives: Device: Total Knee Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in patients reported outcome measures - KOOS Score (Knee injury and Osteoarthritis Outcome Score)
To explore differences between outcome in patients treated with use of with Journey II and Persona prosthesis. Results range from 0 to 100, with higher scores corresponding to better outcomes.
Measured: baseline (preoperatively) and 1 year postoperatively
Changes in patients reported outcome measures - WOMAC Score (Knee injury and Osteoarthritis Outcome Score)
To explore differences between outcome in patients treated with use of with Journey II and Persona prosthesis. Results range from 0 to 96, with higher scores corresponding to worse outcomes.
Measured: baseline (preoperatively) and 1 year postoperatively
Values of components rotation
Values of external or internal rotation of components measured in computed tomography postoperatively. Values in degrees in regards to anatomic bone landmarks
Measured: 1-day postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start1 Oct 2018
- Primary completion1 May 2020
- Study completion24 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Artur Stolarczyk, Medical University of Warsaw
- Investigators
- Artur Stolaerczyk, MD, PhD, Principal investigator, Department of Orthopedics and Rehabilitation, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05038670
- Sponsor's protocol ID
- WarsawMU/persona
- Status last verified
- Aug 2021
- First submitted
- 25 Aug 2021
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Patients-reported Outcome After Total Knee Arthroplasty With Use of Bi-cruciate Stabilized and Personalized Implant Design - Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05038670
- Acronym / sponsor ID
- WarsawMU/persona
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 24 Nov 2020 (actual)
- First posted
- 9 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares and evaluates differences in patient-reported outcome, survivorship and radiological analysis between patients undergoing total knee arthroplasty with use of either Zimmer Biomet PERSONA Posterior Stabilized (PS) system and Smith\&Nephew Journey II Bi-Cruciate Stabilized (BCS) system
Detailed description
The aim of this study is to assess patient-reported outcome, survivorship and radiological analysis in patients after total knee arthroplasty, who will undergo the surgery with the use of either Zimmer Biomet PERSONA Posterior Stabilized (PS) system and Smith\&Nephew Journey II Bi-Cruciate Stabilized (BCS) system.
To this study 45 consecutive patients undergoing total knee arthroplasty will be recruited to each group. Study protocol is designed as a prospective, blinded, parallel-group, superiority trial, with balanced randomization [1:1]. All participants will be operated in single clinical orthopedic department, by single high-volume surgeon, who performed more than 3000 total knee arthroplasties in his professional career.
Before the surgery patients will fulfill the author's questionnaire concerning their age, height and body mass, level of activity, WOMAC and KOOS scales.
1-day posteoperatively patients will undergo standard computed tomography examination to assess components placement
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PERSONA | Active comparator | Device: Total Knee ReplacementPatients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet PERSONA system |
| Journey II | Active comparator | Device: Total Knee ReplacementPatients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Smith\&Nephew Journey II system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Listed for a primary total knee replacement (TKR) at the Orthopaedic and Rehabilitation Department Medical University of Warsaw
- Indication for the TKR is primary osteoarthritis of the knee joint involving one or more compartments
- Aged 18 or over
- Patient willing to provide full informed consent to the trial
Key exclusion criteria (14 listed)
- Listed for a single-stage bilateral TKR procedure
- Severe symptoms in the contralateral knee so as to require staged bilateral knee replacements within 6 months of the primary procedure
- Fixed flexion deformity of 15 degrees or greater who will require excessive resection of the distal femur
- Clinically assessed uncorrectable varus/valgus deformity of 15 degrees or greater
- Any co-morbidity which, in the opinion of the investigator, is severe enough to present an unacceptable risk to the patient's safety
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 |
|---|---|---|
| Total Knee ReplacementParticipant will undergo total knee replacement performed via anterior parapatellar approach with either PERSONA PS or JOURNEY II BCS | Device | Journey II, PERSONA |
Primary outcome
Changes in patients reported outcome measures - KOOS Score (Knee injury and Osteoarthritis Outcome Score)
Time frame: baseline (preoperatively) and 1 year postoperatively
To explore differences between outcome in patients treated with use of with Journey II and Persona prosthesis. Results range from 0 to 100, with higher scores corresponding to better outcomes.
Changes in patients reported outcome measures - WOMAC Score (Knee injury and Osteoarthritis Outcome Score)
Time frame: baseline (preoperatively) and 1 year postoperatively
To explore differences between outcome in patients treated with use of with Journey II and Persona prosthesis. Results range from 0 to 96, with higher scores corresponding to worse outcomes.
Values of components rotation
Time frame: 1-day postoperatively
Values of external or internal rotation of components measured in computed tomography postoperatively. Values in degrees in regards to anatomic bone landmarks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
- Individual participant dataSharing planned: Yes
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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.
Artur Stolaerczyk, MD, PhD principal investigator
Department of Orthopedics and Rehabilitation, Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Knee Replacement in people with Knee Osteoarthritis, run by Medical University of Warsaw at 1 site in Poland.
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 4 inclusion and 14 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 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in patients reported outcome measures - KOOS Score (Knee injury and Osteoarthritis Outcome Score) (time frame: baseline (preoperatively) and 1 year postoperatively). The study lists 3 primary outcomes in all. 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 9 Sep 2021.