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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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12 December 2020 |
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Main ID: |
NCT03339557 |
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Date of registration:
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07/11/2017 |
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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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Comparison of Three Knee Replacements
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Scientific title:
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Functional Outcome of Total Knee Replacement. Randomized Clinical Controlled Trial of Novel and Conventional Implants |
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Date of first enrolment:
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September 1, 2015 |
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Target sample size:
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240 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03339557 |
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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: Triple (Participant, Care Provider, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Finland
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Contacts
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Name:
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Tero Irmola, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Coxa, Hospital for Joint Replacement |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- patients undergoing total knee replacement surgery for primary osteoarthritis
- no previous open major surgery in the joint ( e.g. osteotomy)
- unilateral operative treatment, with no plans for surgical treatment of the
contralateral knee in the near future
- patients living in the local hospital district (Pirkanmaa Hospital District)
- Kellgren-Lawrence grade 3-4 knee osteoarthritis in plain radiographs
Exclusion Criteria:
- Unwilling to provide informed consent
- > 15 degrees varus or valgus, or >15 degree fixed flexion deformity
- predominantly patellofemoral osteoarthritis
- Physical, emotional or neurological conditions that would compromise the patient´s
compliance with postoperative rehabilitation and follow-up (e.g. drug or alcohol
abuse, serious mental illness, general neurological conditions such as Parkinson, MS,
etc.)
Age minimum:
50 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Osteoarthritis, Knee
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Total Knee Replacement
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Arthroplasty
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Intervention(s)
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Device: NexGen
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Device: PFC
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Device: Persona
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Primary Outcome(s)
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Changes in patient reported outcome measures scores (PROMs), Functional improvement
[Time Frame: preoperative, postoperative at 2-3 months, at 1 year and at 2 years]
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Secondary Outcome(s)
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Changes in PROMs, Functional improvement
[Time Frame: preoperative, postoperative at 2-3 months, at 1 year and at 2 years]
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Changes in health-related quality of life (HRQoL)
[Time Frame: preoperative, postoperative at 2-3 months, at 1 year and at 2 years]
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Changes in activity rating scale
[Time Frame: preoperative, postoperative at 2-3 months, at 1 year and at 2 years]
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Changes in pain scale measurement
[Time Frame: preoperative, postoperative at 2-3 months, at 1 year and at 2 years]
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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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