This trial is active, not recruiting.

Conditions anterior cruciate ligament, knee injuries
Treatment acl reconstruction (seriacl™ device)
Phase phase 1
Sponsor Serica Technologies, Inc.
Start date June 2007
End date October 2008
Trial size 30 participants
Trial identifier NCT00490594, CLN-ACL1


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Safety - measured by device related SAEs
time frame: 12 months
KT-1000 Arthrometer
time frame: 12 months

Secondary Outcomes

Knee Surveys
time frame: 12 months
Return to Work
time frame: 12 months

Eligibility Criteria

Male or female participants from 18 years up to 45 years old.

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

Additional Information

Official title A Multi-Center Open Study to Evaluate the SeriACL™ Device for Primary Anterior Cruciate Ligament Repair
Principal investigator Lars Engebretsen, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2008.
Information provided to ClinicalTrials.gov by Serica Technologies, Inc..