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

Knee Injuries Clinical Trial

Official title:

A Multi-Center Open Study to Evaluate the SeriACL™ Device for Primary Anterior Cruciate Ligament Repair

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00490594
• Other study ID #: CLN-ACL1
• Status: Active, not recruiting
• Phase: Phase 1
• First received: June 20, 2007
• Last updated: October 17, 2008
• Start date: June 2007

Study information

• Verified date: October 2008
• Source: Serica Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anterior Cruciate Ligament
• Knee Injuries

Intervention

Device:
• ACL Reconstruction (SeriACL™ Device)
Bioresorbable ACL

Locations

Country	Name	City	State
Germany	Atos Clinic	Heidelberg
Germany	Heidelberg University	Heidelberg
Norway	Ullevaal Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Serica Technologies, Inc.

Countries where clinical trial is conducted

Germany,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety - measured by device related SAEs		12 months	Yes
Primary	KT-1000 Arthrometer		12 months	No
Secondary	Knee Surveys		12 months	No
Secondary	Return to Work		12 months	No