Knee Ligament Injury Clinical Trial
Official title:
Performance and Safety of the Composite Interference Screw Used in Anterior Cruciate Ligament Reconstructions
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
Status | Recruiting |
Enrollment | 56 |
Est. completion date | August 23, 2021 |
Est. primary completion date | August 23, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Acute or chronic ACL 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 froĆ¹ 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 |
Country | Name | City | State |
---|---|---|---|
France | Clinique JUGE | Marseille | Paca |
Lead Sponsor | Collaborator |
---|---|
Biomatlante | ATLANSTAT |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of the objective International Knee Documentation Committee score before and after surgery | Record of the objective International Knee Documentation Committee score (A = normal, B = almost normal, C = abnormal or D = very abnormal) | 4 months before surgey / 7 months post-surgery | |
Primary | Change of the subjective International Knee Documentation Committee score before and after surgery | Record of the subjective International Knee Documentation Committee score (from 1 to 100 where 100 is the best result) | 4 months before surgey / 7 months post-surgery | |
Secondary | Number and precise description of any adverse event during the follow-up | Record and description of any adverse event during the follow-up that reflects the safety of the Composite Interference Screw | Before surgery until 7 months post-surgery | |
Secondary | Change in the patients recovery | Record of recovery informations | 2 months post-surgery |
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