Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT04076956
Status:
COMPLETED
Last Update Posted:
2025-02-04
First Post:
2019-08-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Performance and Safety of the Composite Interference Screw Used in Anterior Cruciate Ligament Reconstructions
Sponsor:
Biomatlante
Organization:
Study Overview
Official Title:
Performance and Safety of the Composite Interference Screw Used in Anterior Cruciate Ligament Reconstructions
Status:
COMPLETED
Status Verified Date:
2025-02
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:
None
Brief Summary:
The evaluation of the clinical data has demonstrated the conformity of the Composite Interference Screw (CIS), with the relevant essential requirements for its use in orthopaedic applications. The Composite Interference Scres are intended for tibial and femoral ligament/graft fixation in the case or Anterior Cruciate Ligament (ACL) reconstructions. It has been concluded that the risks associated with the use of the device are acceptable when weighted against the benefits to the patients. In order to improve the clinical data on the CIS, the manufacturer, Biomatlante, decided to assess that the performance and safety of the device are maintained until the reaching of its intended use. In this objective, the goal of this study will be to observe the following parameters:
1. Objective IKDC score (clinical evaluation)
2. Subjective IKDS score (functional evaluation)
3. Safety (report of any adverse event)
4. Follow-up of the patient's recovery
1. Objective IKDC score (clinical evaluation)
2. Subjective IKDS score (functional evaluation)
3. Safety (report of any adverse event)
4. Follow-up of the patient's recovery
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: