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

NCT04076956 — Completed, 55 participants, Biomatlante

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Registry	NCT04076956
Status	Completed
Study type	Observational
Enrollment	55 (Actual)
Sponsor	Biomatlante (Industry); collaborators: Atlanstat
Conditions	Knee Ligament Injury
Interventions	Anterior Cruciate Ligament Reconstruction (Device)
Dates	start 2019-08-23, primary completion 2021-06-15, completion 2021-06-15, first posted 2019-09-04, last updated 2025-02-04
Locations	1 site in France

-Summary

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

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+Arms and interventions

Anterior Cruciate Ligament Reconstruction (Device): Reconstruction of the Anterior Cruciate Ligament using an interference screw

+Outcome measures

Primary outcomes

Change of the objective International Knee Documentation Committee score before and after surgery [4 months before surgey / 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 surgey / 7 months post-surgery]: Record of the subjective International Knee Documentation Committee score (from 1 to 100 where 100 is the best result)

Secondary outcomes

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 Composite Interference Screw
Change in the patients recovery [2 months post-surgery]: Record of recovery informations

+Eligibility

Sex: All, ages: 18 Years to 60 Years

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 froù 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

+Locations (1)

Facility	City	Country	Status
Clinique JUGE	Marseille, PACA	France

+Study documents

Study Protocol (PDF, 2019-05-15)

+Investigators

Jaafar JS SBIHI, M.D., Principal investigator, Clinique Juge