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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: |
NCT02580643 |
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Date of registration:
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19/10/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Prospective Post-Market Data Collection on Patients With Knee OA and Treated With nSTRIDE APS
PROGRESS III |
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Scientific title:
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Prospective Post-Market Data Collection on Patients With Knee Osteoarthritis and Treated With nSTRIDE Autologous Protein Solution (REGP-22-00) |
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Date of first enrolment:
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May 2016 |
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Target sample size:
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78 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02580643 |
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Study type:
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Observational [Patient Registry] |
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Study design:
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Phase:
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Countries of recruitment
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Austria
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Norway
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Poland
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- OA of one or both knees as diagnosed by the treating physician
- At least 18 years of age
- Willing and able to comply with the study procedures
- Signed informed consent form
Exclusion Criteria:
- Any systemic inflammatory condition ( e.g., rheumatoid arthritis)
- Active malignancy at time of injection
- Pregnant at time of injection
- Lactating at the time of injection
- Knee joint infections or skin diseases or infections in the area of the injection
site.
- Leukemia, metastatic malignant cells, or who are receiving chemotherapeutic treatment
- Participating in another device or drug study
Age minimum:
18 Years
Age maximum:
N/A
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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Biological: APS
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Primary Outcome(s)
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Knee pain and function
[Time Frame: Through 12 months]
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Secondary Outcome(s)
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European Quality of Life 5 Dimensions 3 Levels (EQ-5D-3L)
[Time Frame: Evaluated at 2 and 4 weeks and 3, 6 and 12 months]
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Procedural complications and adverse events
[Time Frame: Through 12 months]
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Characterize the time from the initial nSTRIDE injection to subsequent nSTRIDE injection(s) or other intrusive treatment.
[Time Frame: Through 12 months]
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Knee Injury and Osteoarthritis Outcome Score (KOOS)
[Time Frame: Evaluated at 2 and 4 weeks and 3, 6 and 12 months]
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Numeric Rating Scales (NRS)
[Time Frame: Evaluated at 2 and 4 weeks and 3, 6 and 12 months]
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Secondary ID(s)
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BBIO.CRNSAPS002.15
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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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