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

Knee Ligament Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04122677
• Other study ID #: 2018-A03207-48
• Status: Recruiting
• Start date: November 14, 2019
• Est. completion date: October 5, 2021

Study information

• Verified date: January 2020
• Source: Biomatlante
• Contact: Laura LP PAGNUCCO, Master II
• Phone: 0228020009
• Email: laurapagnucco[@]biomatlante.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: October 5, 2021
• Est. primary completion date: October 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Ligament Injury

Intervention

Device:
• Anterior Cruciate Ligament Reconstruction
Reconstruction of the Anterior Cruciate Ligament using an interference screw.

Locations

Country	Name	City	State
France	Centre ORTHEO	Saint-Étienne	Loire

Sponsors (2)

Lead Sponsor	Collaborator
Biomatlante	ATLANSTAT

Country where clinical trial is conducted

France, 

Outcome

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 surgery / 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 surgery / 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 Polylactic Interference Screw	Before surgery until 7 months post-surgery
Secondary	Change in the patients recovery	Record of specific items of the Objective International Knee Documentation Committee score reflecting the patients recovery	2 months post-surgery