SeriACL™ Device Trial for Anterior Cruciate Ligament (ACL) Reconstruction

Phase 1

• Conditions: Anterior Cruciate Ligament; Knee Injuries

• Registration Number: NCT00490594
• Lead Sponsor: Serica Technologies, Inc.

Brief Summary

The SeriACL device was developed as an alternative to an autograft (i.e., tissue that is taken from a patient's own body) or an allograft (i.e., tissue that is taken from a cadaver) for ACL reconstruction. The SeriACL device is made of silk yarns, knit and processed with SeriCoat™ surface treatment which makes it easier to wet the material. The SeriACL device is designed to be a temporary support structure to replace the torn ACL and to stabilize the knee joint following surgical repair. It is designed to use the body's own healing process to regenerate the patient's own new ligament tissue. As the new tissue grows and the support structure is needed less over time, the SeriACL device is bioresorbed (i.e., broken down) by the patient's body. The SeriACL device is designed to be installed with standard surgical techniques for ACL repair.

This study is designed to test the safety of the SeriACL device in primary total ACL repair in patients with a torn ACL. The study will evaluate whether repair of the ACL with the SeriACL device will return the knee to normal function and what, if any, side effects will occur.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-06-20
• Study First Submitted QC: 2007-06-21
• Study First Posted: 2007-06-22
• Status Verified: 2008-10
• Primary Completion: 2008-10
• Last Update Submitted: 2008-10-17
• Last Update Posted: 2008-10-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Complete ACL rupture
• Injured knee range of motion >= 75% of contralateral knee
• MCL tear grading <= 2
• Sign informed consent.

Exclusion criteria:

• Prior ACL reconstruction
• Complete PCL tear
• Locked bucket handle tear or complex tears of the menisci.
• Contralateral knee ligament injury
• Known joint disease
• Known allergy to silk
• Active drug or alcohol abuse
• Pregnant

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
KT-1000 Arthrometer	12 months
Safety - measured by device related SAEs	12 months

Secondary Outcome Measures

Name	Time	Method
Knee Surveys	12 months
Return to Work	12 months

Trial Locations

Locations (3)

Heidelberg University; 🇩🇪 Heidelberg, Germany

Ullevaal Hospital; 🇳🇴 Oslo, Norway

Atos Clinic; 🇩🇪 Heidelberg, Germany