Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05229458 |
| Other study ID # |
YYDATP-PMCF |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 2022 |
| Est. completion date |
December 2022 |
Study information
| Verified date |
April 2022 |
| Source |
Yooyoung Pharmaceutical Co., Ltd. |
| Contact |
Franco Barattini, MD |
| Phone |
+40 774012684 |
| Email |
franco.barattini[@]tigermedgrp.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This trial is a post marketing clinical follow up study, aiming to evaluate the performance
and safety of Hyalexo for pain relief in patients suffering from osteoarthritis or
degenerative joint diseases.
The study will involve 54 subjects, who will be enrolled in 4 centers in France. The
performance outcomes will be evaluated by the koos score, and VAS for pain, while the safety
outcomes will be assessed by a safety checklist and by collecting all the adverse events
(Adverse Event/Adverse Device Effect/Serious Adverse Event/Serious Adverse Device
Effect/Unanticipated Serious Adverse Device Effect/Device Deficiencies) at all visits.
Description:
Design:
Open, non-randomised, non-comparative, single group assignment, multicentre study.
Chronogram of visits:
The study foresees the following visits per patient:
- Visit 1 day -3 to day -1: Screening.
- Visit 2 day 0: Baseline visit (1st injection).
- Visit 3 day 7 (± 1 day): Follow up visit and, 2nd injection.
- Visit 4 day 14 (± 2 days): Follow up visit and, 3rd injection.
- Visit 5 day 21 (± 2 days): Follow up visit.
- Visit 6 day 56 (± 2 days): Follow up visit.
- Visit 7 day 98 (± 2 days): Follow up visit.
- Visit 8 day 194 (± 4 days): Final visit.
Patient enrollment and allocation:
After informed consent signature, the patient is considered enrolled. Once the eligibility is
established according to inclusion/exclusion criteria the patient will receive a unique
patient code and will be allocated to HYALEXO® (the tested medical device). The Investigator
must also complete a patient screening log, which reports on all patients who were seen to
determine eligibility for inclusion in the study.
Statistical Analysis:
The protocol outlines that a two-sided p-value of 0.05 or less will be used to declare
statistical significance for all analyses. Similarly, all confidence intervals will be
calculated at the 95% level.
No adjustment for multiplicity will be made to adjust type 1 error rate for secondary
endpoints. If necessary, relevant results from other studies already reported in the
literature will be considered in the interpretation of results.
The final analysis will be completed after all patients have been exited the study, all
queries resolved, and the database have been locked.
If a patient is missing information for one or more variables, the missing data will not be
replaced. Quantitative variables (i.e., demographic) if normally distributed will be
described through media, standard deviation (SD); variables non-normally distributed will be
described using median and range of interquartile.
Considering this clinical trial's design as a longitudinal cohort study, the focus of the
performed statistical assessments will be the longitudinal (statistical) analysis.
Primary endpoint, change in Knee injury and Osteoarthritis Outcome Score(KOOS) pain sub-scale
score from baseline to 14 weeks visit, will be analysed by performing a Student's t-test for
paired data, or a Wilcoxon signed rank test if major deviations from former's test
assumptions are recorded. As no missing data imputation on the primary outcome is planned, if
such cases arise, a Linear Mixed Model analysis will be performed, to make use of the
complete ITT(Intention to treat) population.
Secondary endpoints, all continuous variables in nature, will be assessed by performing ANOVA
for repeated measures tests, or ANCOVA for repeated measures tests (if considering covariates
like age, sex, BMI, etc.), assuming completeness of data (no missing data). If missingness of
data drastically reduces the sample size (e.g., > 5% of patients will be eliminated), a
robust statistical analysis method will be employed instead. Such a method, Linear Mixed
Models analysis, has the main advantage of making use of the complete ITT population.
The safety analysis will be done on the ITT population.
