Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
45 participants
INTERVENTIONAL
2018-10-01
2020-11-24
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Outcomes Assessor, who will be not present during surgery, will not be informed which type of prosthesis was used in particular patient.
Study Groups
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PERSONA
Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet PERSONA system
Total Knee Replacement
Participant will undergo total knee replacement performed via anterior parapatellar approach with either PERSONA PS or JOURNEY II BCS
Journey II
Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Smith\&Nephew Journey II system
Total Knee Replacement
Participant will undergo total knee replacement performed via anterior parapatellar approach with either PERSONA PS or JOURNEY II BCS
Interventions
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Total Knee Replacement
Participant will undergo total knee replacement performed via anterior parapatellar approach with either PERSONA PS or JOURNEY II BCS
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Medical University of Warsaw
OTHER
Responsible Party
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Artur Stolarczyk
Head of the Department of Orthopedics and Rehabilitation
Principal Investigators
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Artur Stolaerczyk, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Orthopedics and Rehabilitation, Medical University of Warsaw
Locations
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Department of Othopedics and Rehabilitation, Medical University of Warsaw
Warsaw, Masovian Voivodeship, Poland
Countries
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Other Identifiers
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WarsawMU/persona
Identifier Type: -
Identifier Source: org_study_id
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