Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-25 @ 3:29 AM
NCT ID:
NCT06087705
Brief Summary:
Patients who are to benefit from an injection of SYNOVIUM HCS as part of their care will be offered to participate in this study. Patients will need to sign a consent form to participate. Prior to SYNOVIUM HCS injection, patients will be asked a series of questions regarding their pain and disability. Data collected during follow-up visits can be compared to pre-injection data.
Detailed Description:
Inclusion period: 6 months
Follow-up period:
* 6-month follow-up, after intra-articular injection with extension
* 1 single syringe of SYNOVIUM HCS (3 mL),
* Controls scheduled at 1 week, 1, 3, 6 months and up to 1 year
* Additional control (single) in the event of leaving the study if this takes place outside the scheduled visit dates and before 1 year, for medical reasons
* Duration of the study: Overall time estimated at 18 months
* In this open-label CI, the group itself is used as a control, by comparing the scores on inclusion with those of the various control visits.
Study:
NCT06087705
Study Brief:
Protocol Section:
NCT06087705