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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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5 December 2022 |
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Main ID: |
NCT03494348 |
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Date of registration:
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03/04/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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RSA Study of Persona TKA With CR vs MC Polyethylene
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Scientific title:
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Aspects of Alignment, Function, and Migration Behaviour in Two Conceptually Different Articular Surface Designs in the Cruciate Retaining Version of the Cemented Persona Knee System - A Randomized Study Evaluated by RSA and CT Analysis |
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Date of first enrolment:
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October 1, 2017 |
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Target sample size:
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60 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03494348 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
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Phase:
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N/A
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Gunnar Flivik, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Dept of Orthopedics, Skåne University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Osteoarthritis of the knee necessitating knee replacement
- ASA I-III
- BMI 18 - 35
Exclusion Criteria:
- Joint sepsis in history
- immunosuppresive drugs last 5 years
- Rheumatoid arthritis
- Severe osteoporosis or other metabolic bone diseases
- Neuromuscular diseases
- Personal disorders suspected of limiting rehab and completion of the trial period
- Previous osteotomy of affected limb
- Intra-articular knee fracture of affected limb
- Peroperative fracture
- Severe deformity of affected joint in need of augmentation or excessive release
- Obvious need for more constrained knee than CR
Age minimum:
50 Years
Age maximum:
85 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Osteoarthritis, Knee
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Intervention(s)
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Device: Medial Congruent Polyethylene (MC)
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Primary Outcome(s)
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Radiostereometry (RSA)
[Time Frame: First postoperative day, 3 months, 1 year, 2 years and 5 years]
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Secondary Outcome(s)
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General health questionnaire
[Time Frame: Preoperatively, 1, 2 and 5 years postoperatively]
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Conventional radiography
[Time Frame: Preoperatively and 3 months postoperatively]
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Knee specific health questionnaire
[Time Frame: Preoperatively, 1, 2 and 5 years postoperatively]
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Computer Tomography (CT)
[Time Frame: Preoperatively and 3 months postoperatively]
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Secondary ID(s)
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Persona RSA study_MT
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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