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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 20, 2014