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

This study has been completed.
Sponsor:
Information provided by:
Serica Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT00775892
First received: October 16, 2008
Last updated: August 7, 2011
Last verified: August 2011
  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 1
Phase 2

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Safety - Adverse Events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • KT-1000 Arthrometer Knee Laxity [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Knee Surveys [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2008
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: SeriACL Device ACL Reconstruction
    Long-term Bioresorbable ACL Scaffold
  Eligibility

Ages Eligible for Study:   18 Years to 55 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

Locations
Austria
Dr. Pierer Sanatorium
Salzburg, Austria
Belgium
UZ Leuven
Leuven, Belgium
Germany
Dietrich-Bonhöffer-Klinik
Altentreptow, Germany
Medizinische Hochschule Hannover
Hannover, Germany
ATOS Clinic
Heidelberg, Germany
University of Heidelberg
Heidelberg, Germany
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
Principal Investigator: Uwe Pietzner, MD Dietrich-Bonhöffer-Klinik, Altentreptow, Germany
Principal Investigator: Michael Jagodzsinki, MD Hannover Medical School
  More Information

No publications provided

Responsible Party: Rebecca L Horan, PhD, Serica Technologies, Inc.
ClinicalTrials.gov Identifier: NCT00775892     History of Changes
Other Study ID Numbers: CLN-ACL1B
Study First Received: October 16, 2008
Last Updated: August 7, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Serica Technologies, Inc.:
ACL
Ligament

ClinicalTrials.gov processed this record on April 17, 2014