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NCT04076956
Performance and Safety of the Composite Interference Screw Used in Anterior Cruciate Ligament Reconstructions
trial testing Anterior Cruciate Ligament Reconstruction in Knee Ligament Injury in 55 participants. Completed in 15 June 2021.
15 June 2021
Quick facts
| Lead sponsor | Biomatlante |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 55 |
| Start date | 23 August 2019 |
| Primary completion | 15 June 2021 |
| Estimated completion | 15 June 2021 |
| Sites | 1 location across France |
Drugs / interventions tested
- Anterior Cruciate Ligament Reconstruction
Conditions studied
- Knee Ligament Injury — all drugs for Knee Ligament Injury →
Sponsor
Biomatlante
Who can join
Adults 18 to 60, any sex, with Knee Ligament Injury. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04076956
- Europe PMC full search
- ASCO Meeting Library
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Related trials
Other trials of Anterior Cruciate Ligament Reconstruction
Trials testing the same drug.
- NCT05574946 — Comparison of Two ACL Reconstruction Techniques: All-inside Versus Complete Tibial Tunnel Technique · NA · completed
- NCT04122677 — Performance and Safety of the Polylactic Interference Screw Used in Anterior Cruciate Ligament Reconstructions · completed
- NCT03529552 — Evaluation After Reconstruction of the Anterior Cruciate Ligament of the Knee Using the Bioresorbable Interference Screw · NA · terminated
- NCT02795247 — Comparison of 3 Techniques for Recreation of Anterior Cruciate Ligament Anatomic Footprint · NA · completed
- NCT06058494 — Multi-scale Modeling for Predictive Characterization of Ligaments and Grafts Behavior in ACL Reconstruction · completed
Other Biomatlante trials
Trials by the same sponsor.
- NCT04122677 — Performance and Safety of the Polylactic Interference Screw Used in Anterior Cruciate Ligament Reconstructions · completed
- NCT03978962 — Performance and Safety of the Resorbable Collagen Membrane "Ez Cure" · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04076956 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Biomatlante
- Last refreshed: 4 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04076956.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing