Knee Ligament Injury
Conditions
Keywords
Knee Ligament Injury, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Reconstruction, Knee Ligament Rupture, Knee Ligament Reconstruction
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
Interventions
DEVICEAnterior Cruciate Ligament Reconstruction
Reconstruction of the Anterior Cruciate Ligament using an interference screw.
Sponsors
Atlanstat
Biomatlante
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of the objective International Knee Documentation Committee score before and after surgery | 4 months before surgery / 7 months post-surgery | Record of the objective International Knee Documentation Committee score (A = normal, B = almost normal, C = abnormal or D = very abnormal) |
| Change of the subjective International Knee Documentation Committee score before and after surgery | 4 months before surgery / 7 months post-surgery | Record of the subjective International Knee Documentation Committee score (from 1 to 100 where 100 is the best result) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number and precise description of any adverse event during the follow-up | Before surgery until 7 months post-surgery | Record and description of any adverse event during the follow-up that reflects the safety of the Polylactic Interference Screw |
| Change in the patients recovery | 2 months post-surgery | Record of specific items of the Objective International Knee Documentation Committee score reflecting the patients recovery |
Countries
France
Outcome results
None listed