Phase None Completed NCT04122677

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

Biomatlante · Observational

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Knee Ligament Injury (ACL Tear)

Study context Single-site study

Overview

The evaluation of the clinical data has demonstrated the conformity of the Polylactic Interference Screw (PIS), with the relevant essential requirements for its use in orthopaedic applications. The Polylactic Interference Screws 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 PIS, 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: Objective IKDC score (clinical evaluation) Subjective IKDS score (functional evaluation) Safety (report of any adverse event) Follow-up of the patient's recovery

Full record on ClinicalTrials.gov (NCT ID NCT04122677).

Results summary

None

Outcome data

Endpoint	Type	Result	Significance
Change of the objective International Knee Documentation Committee score before and after surgery	Primary	None	None
Change of the subjective International Knee Documentation Committee score before and after surgery	Primary	None	None
Number and precise description of any adverse event during the follow-up	Secondary	None	None
Change in the patients recovery	Secondary	None	None

Full results record on ClinicalTrials.gov.

Study design

Phase: Phase None
Study type: Observational
Enrollment (final): 55 participants
Started: November 2019
Actually completed: December 2022

Recruitment criteria

Age range: 18–60 · Sex: All · Healthy volunteers: Requires diagnosis

Locationsⁱ

1 site participated during the trial period. Representative sites shown below; full historical record on ClinicalTrials.gov.

Centre ORTHEO — Saint-Étienne-de-Montluc, Pays de la Loire Region (France)

Sources

REG

ClinicalTrials.gov — NCT04122677

Trial registry · primary record