NCT04076956

Performance and Safety of the Composite Interference Screw Used in Anterior Cruciate Ligament Reconstructions

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 55 (actual)
• Sponsor: Biomatlante · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Conditions

• Knee Ligament Injury

Interventions

Type	Name	Description
DEVICE	Anterior Cruciate Ligament Reconstruction	Reconstruction of the Anterior Cruciate Ligament using an interference screw

Timeline

• Start date: 2019-08-23
• Primary completion: 2021-06-15
• Completion: 2021-06-15
• First posted: 2019-09-04
• Last updated: 2025-02-04

Locations

1 site across 1 country: France