SeriACL™ Device (Gen IB) Trial for Anterior Cruciate Ligament (ACL) Repair

Anterior Cruciate Ligament Reconstruction Clinical Trial

Official title:

A Multi-Center Open Label Study to Evaluate the SeriACL™ Device (Gen IB) for Primary Anterior Cruciate Ligament Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00775892
• Other study ID #: CLN-ACL1B
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 16, 2008
• Last updated: August 7, 2011
• Start date: September 2008

Study information

• Verified date: August 2011
• Source: Serica Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

A multi-center single-arm clinical trial is being conducted to evaluate SeriACL device safety and performance during total anterior cruciate ligament (ACL) reconstruction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Major Inclusion Criteria:

• Complete rupture of the ACL

• Passive flexion >= 120° and passive extension = contralateral knee

• MCL grade 2 or less

• Pre-injury Tegner score >= 4

• Informed Consent

Major Exclusion Criteria:

• Prior ACL reconstruction.

• Severe pain, swelling, or redness

• Complete PCL tear

• Complex menisci tears

• Contralateral knee ligament injury

• OA > Grade II

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Reconstruction

Intervention

Device:
• SeriACL Device ACL Reconstruction
Long-term Bioresorbable ACL Scaffold

Locations

Country	Name	City	State
Austria	Dr. Pierer Sanatorium	Salzburg
Belgium	UZ Leuven	Leuven
Germany	Dietrich-Bonhöffer-Klinik	Altentreptow
Germany	Medizinische Hochschule Hannover	Hannover
Germany	ATOS Clinic	Heidelberg
Germany	University of Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Serica Technologies, Inc.

Countries where clinical trial is conducted

Austria,  Belgium,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety - Adverse Events		12 months	Yes
Primary	KT-1000 Arthrometer Knee Laxity		12 months	No
Secondary	Knee Surveys		12 months	No