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

This study is currently recruiting participants.

Verified by Serica Technologies, Inc., October 2008

Sponsored by:	Serica Technologies, Inc.
Information provided by:	Serica Technologies, Inc.
ClinicalTrials.gov Identifier:	NCT00775892

Purpose

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

Condition	Intervention	Phase
Anterior Cruciate Ligament Reconstruction	Device: SeriACL Device ACL Reconstruction	Phase I Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Multi-Center Open Label Study to Evaluate the SeriACL™ Device (Gen IB) for Primary Anterior Cruciate Ligament Repair

Further study details as provided by Serica Technologies, Inc.:

Primary Outcome Measures:

Safety - Adverse Events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
KT-1000 Arthrometer Knee Laxity [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Knee Surveys [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	September 2008
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Long-term Bioresorbable ACL Scaffold

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00775892

Contacts

Contact: Rebecca L Horan, PhD

+7813955552

rebecca.horan@sericainc.com

Locations

Austria
Dr. Pierer Sanatorium	Not yet recruiting
Salzburg, Austria
Contact: Gerhard Oberthaler, MD
Principal Investigator: Gerhard Oberthaler, MD
Belgium
UZ Leuven	Recruiting
Leuven, Belgium
Contact: Johan Bellemans, MD
Principal Investigator: Johan Bellemans, MD
Germany
ATOS Clinic	Recruiting
Heidelberg, Germany
Contact: Hans Paessler, MD
Principal Investigator: Hans Paessler, MD
University of Heidelberg	Recruiting
Heidelberg, Germany
Contact: Holger Schmitt, MD
Principal Investigator: Holger Schmitt, MD

Sponsors and Collaborators

Serica Technologies, Inc.

Investigators

Principal Investigator:	Hans Paessler, MD	ATOS Clinic, Heidelberg
Principal Investigator:	Johan Bellemans, MD	UZ Leuven, Belgium
Principal Investigator:	Holger Schmitt, MD	University of Heidelberg, Germany
Principal Investigator:	Gerhard Oberthaler, MD	Dr. Pierer Sanatorium, Salzburg, Austria

More Information

Responsible Party:	Serica Technologies, Inc. ( Rebecca L Horan, PhD )
Study ID Numbers:	CLN-ACL1B
Study First Received:	October 16, 2008
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00775892
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Serica Technologies, Inc.:

ACL
Ligament

ClinicalTrials.gov processed this record on January 16, 2009