Clinical trial NCT04122677: Performance and Safety of the Polylactic Interference Screw Used in Anterior Cruciate Ligament Reconstructions
Official title: Performance and Safety of the Polylactic Interference Screw Used in Anterior Cruciate Ligament Reconstructions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Ligament Injury
Keywords: Knee Ligament Injury
Anterior Cruciate Ligament Rupture
Anterior Cruciate Ligament Reconstruction
Knee Ligament Rupture
Knee Ligament Reconstruction
Lead sponsor: Biomatlante
Sponsor class: INDUSTRY
Collaborators: name: Atlanstat
First posted: 2019-10-10
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population is considered as all the patients included in the study that meet the inclusion and exclusion criteria.

The study population is composed of 56 patients according to the protocol.

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

* Acute or chronic Anterior Cruciate Ligament deficiency with complete or partial lesion of the anteromedial bundle requiring primary reconstruction of the Anterior Cruciate Ligament with hamstring tendons
* Males or females aged from 18 to 60 years
* No history of surgery on the affected knee
* Patients not under guardianship or judicial protection
* Signature of non opposition form (consent of the patient

Exclusion Criteria:

* History of ligament, meniscal surgery or fracture of the affected knee
* Pregnancy of breastfeeding women

Primary outcomes:
measure: Change of the objective International Knee Documentation Committee score before and after surgery
timeFrame: 4 months before surgery / 7 months post-surgery
measure: Change of the subjective International Knee Documentation Committee score before and after surgery
timeFrame: 4 months before surgery / 7 months post-surgery
Secondary outcomes:
measure: Number and precise description of any adverse event during the follow-up
timeFrame: Before surgery until 7 months post-surgery
measure: Change in the patients recovery
timeFrame: 2 months post-surgery
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Centre ORTHEO
state: Loire
Study officials:
affiliation: Centre ORTHEO
name: François-Xavier FV VERDOT, M.D.
role: PRINCIPAL_INVESTIGATOR
References: