Persona MC Retained PCL vs. Persona Posterior-stabilized vs. NexGen PS
Persona TKA
Comparison of the Persona Medial Congruent Retained Posterior-Cruciate Ligament vs. Persona Posterior-stabilized vs. NexGen Posterior-Stabilized Total Knee Arthroplasty a Randomised Controlled Trial
1 other identifier
interventional
100
1 country
1
Brief Summary
This study compares and evaluates differences in movement analysis, patient-reported outcome and radiological assesment between patients undergoing total knee arthroplasty with use of either Zimmer Biomet NexGen and Zimmer Biomet PERSONA
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable knee-osteoarthritis
Started Jul 2020
Typical duration for not_applicable knee-osteoarthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2019
CompletedFirst Posted
Study publicly available on registry
November 15, 2019
CompletedStudy Start
First participant enrolled
July 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedAugust 2, 2021
July 1, 2021
1.4 years
October 31, 2019
July 25, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in patients reported outcome measures - Oxford Knee Score (OKS)
To explore differences between outcome in patients treated with use of with Nexgen and Persona prosthesis. Results range from 0 to 48, with higher scores corresponding to better outcomes.
baseline (preoperatively) and 6-months postoperatively
Secondary Outcomes (18)
Changes in patients reported outcome measures - Oxford Knee Score (OKS)
1 week and 6-8 weeks post-operatively
Changes in patients reported outcomes - Oxford Knee Score Activity & Participation Questionnaire (OKS_APQ)
1 week, 6-8 weeks and 6 months post- operatively
Changes in patients reported outcomes - EuroQol (EQ- 5D-5L)
1 week, 6-8 weeks and 6 months post- operatively
Changes in patients reported outcomes - Forgotten Joint Score (FJS)
6-8 weeks and 6 months post-operatively
Changes in patients reported outcomes - UCLA (University of California) score
6-8 weeks and 6 months post-operatively
- +13 more secondary outcomes
Study Arms (3)
NexGen
ACTIVE COMPARATORPatients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet NexGen prosthesis
Persona MC Retained PCL
ACTIVE COMPARATORPatients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet Persona MC Retained PCL prosthesis
Persona MC Sacrificed PCL
ACTIVE COMPARATORPatients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet Persona MC Sacrificed PCL prosthesis
Interventions
Participant will undergo total knee replacement performed via anterior parapatellar approach with either Posterior Cruciate Ligament sacrificing or retaining implant
CT scans of the affected knee joint before and after the surgical procedure
Participants will be asked to perform biomechanical assesment before and following surgery at baseline, 6-8 weeks and 6-months postoperatively
Participant are randomly allocated to receive one of the Persona MC Retained PCL, Persona MC Sacrificed PCL and the NexGen PS total knee implant for treatment of end-stage knee osteoarthritis.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Previous septic arthritis in the affected knee joint
- Previous surgery to the collateral ligaments of the affected knee
- A contralateral total knee replacement that has been implanted less than one year from the date of consultation
- A contralateral total knee replacement that is severely painful
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Othopedics and Rehabilitation, Medical University of Warsaw
Warsaw, Poland
Related Publications (1)
Maciag BM, Kordyaczny T, Jegierski D, Lapinski M, Dorocinska M, Zarnovsky K, Maciag GJ, Adamska O, Stolarczyk A. Differences in joint line level and posterior condylar offset during total knee replacement with use of gap-balancing and measured resection techniques-matched cohort study. BMC Musculoskelet Disord. 2023 Jul 25;24(1):610. doi: 10.1186/s12891-023-06722-1.
PMID: 37491199DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Artur Stolarczyk, PhD
Medical University of Warsaw
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Participant will not be informed which type of prosthesis was used in their particular case. Outcomes Assessor will not be informed which type of prosthesis was used in particular patient.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of the Department of Orthopedic and Rehabilitation
Study Record Dates
First Submitted
October 31, 2019
First Posted
November 15, 2019
Study Start
July 1, 2020
Primary Completion
December 1, 2021
Study Completion
December 31, 2022
Last Updated
August 2, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share