Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06156384
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2023-11-22
Brief Title:
Study to Assess the Pain Satisfaction and Quality of Life of Patients With FITBONE Lengthening Nail
Sponsor:
Orthofix srl
Organization:
Orthofix srl
Study Overview
Official Title:
Prospective Observational Study to Assess the Pain Satisfaction and Quality of Life of Patients Implanted With the FITBONE Lengthening Nail
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FitForFrance
Brief Summary:
This study is a prospective observational non-interventional multi-centre cohort study of patients 12 years or older initiating a lower limb lengthening procedure with FITBONE and who have a length discrepancy of 30mm or more between the limbs
The following parameters will be assessed for up to 24 months
Pain using the Visual Analog Scale VAS Patient Global Assessment PGA and Clinical Observer Global Assessment COGA
Patient satisfaction using the Patient Global Impression of change PGI-C scale
QoL using the 36-Item Short Form SurveyPaediatric Quality of Life Inventory SF-36PedsQL
The following parameters will be assessed for up to 24 months
Pain using the Visual Analog Scale VAS Patient Global Assessment PGA and Clinical Observer Global Assessment COGA
Patient satisfaction using the Patient Global Impression of change PGI-C scale
QoL using the 36-Item Short Form SurveyPaediatric Quality of Life Inventory SF-36PedsQL
Detailed Description:
The study period is 24 months post-surgery Each patients demographic data medical history any relevant concomitant medication physical examination range of motion data will be recorded using a standardized case record form after informed consent is provided and the healthcare provider completes a physical examination regarding the patients conditions and record determination as to whether FITBONE is recommended The decision to treat observe and to include in this observation study is at the discretion of the healthcare provider This is an observational study and therefore the participating healthcare provider will manage patients according to the usual clinical practice
Surgery will be performed according to the standard surgical procedure described previously Study of Investigational Products Five to ten days after the lengthening nail placement the lengthening mechanism is operated by transmitting energy necessary for the lengthening from the outside This period is referred to as the distraction period The rhythm of lengthening and strict protocol for an individual patient indicating the daily lengths of lengthening to be applied are decided by the healthcare provider taking into account all influencing factors Therefore the end of the distraction period bone healing implant removal and 6 months post-implant removal may differ by individual In the event the distraction period is extended by the healthcare provider the new distraction period will determine the end of the distraction time point All patients will be followed until the end of the scheduled study period regardless of any change in their treatment or other conditions
Six visits are planned
1 Surgery baseline
2 End of the distraction phase
3 End of bone healing
4 Implant removal
5 6-month post-removal
6 24-month post-surgery The satisfaction will be assessed at implant removal 6 months post implant removal and 24 months post-surgery
The QoL will be assessed at baseline at 6 months post implant removal and 24 months post-surgery
Pain will be assessed at all timepoints Measurement of pain at the end of the distraction phase the patient will be requested to report the pain experienced in the past week at the moment and during or immediately after the distraction period At other time points pain for only at the moment will be captured
Range of motion ROM will be measured at the end of bone healing and at the 24 months post-surgery
Lengthening achieved will be measured at the end of bone healing Any incidence of adverse events will be recorded at any point during the 24-month follow-up period
Surgery will be performed according to the standard surgical procedure described previously Study of Investigational Products Five to ten days after the lengthening nail placement the lengthening mechanism is operated by transmitting energy necessary for the lengthening from the outside This period is referred to as the distraction period The rhythm of lengthening and strict protocol for an individual patient indicating the daily lengths of lengthening to be applied are decided by the healthcare provider taking into account all influencing factors Therefore the end of the distraction period bone healing implant removal and 6 months post-implant removal may differ by individual In the event the distraction period is extended by the healthcare provider the new distraction period will determine the end of the distraction time point All patients will be followed until the end of the scheduled study period regardless of any change in their treatment or other conditions
Six visits are planned
1 Surgery baseline
2 End of the distraction phase
3 End of bone healing
4 Implant removal
5 6-month post-removal
6 24-month post-surgery The satisfaction will be assessed at implant removal 6 months post implant removal and 24 months post-surgery
The QoL will be assessed at baseline at 6 months post implant removal and 24 months post-surgery
Pain will be assessed at all timepoints Measurement of pain at the end of the distraction phase the patient will be requested to report the pain experienced in the past week at the moment and during or immediately after the distraction period At other time points pain for only at the moment will be captured
Range of motion ROM will be measured at the end of bone healing and at the 24 months post-surgery
Lengthening achieved will be measured at the end of bone healing Any incidence of adverse events will be recorded at any point during the 24-month follow-up period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-A02702-43 | OTHER | ID-RCB number France | None |