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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00775892
Recruitment Status : Completed
First Posted : October 20, 2008
Last Update Posted : August 9, 2011
Sponsor:
Information provided by:
Serica Technologies, Inc.

Tracking Information
First Submitted Date  ICMJE October 16, 2008
First Posted Date  ICMJE October 20, 2008
Last Update Posted Date August 9, 2011
Study Start Date  ICMJE September 2008
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2009)
  • Safety - Adverse Events [ Time Frame: 12 months ]
  • KT-1000 Arthrometer Knee Laxity [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 16, 2008)
  • Safety - Adverse Events [ Time Frame: 6 months ]
  • KT-1000 Arthrometer Knee Laxity [ Time Frame: 6 months ]
Change History Complete list of historical versions of study NCT00775892 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2009)
Knee Surveys [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2008)
Knee Surveys [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SeriACL™ Device (Gen IB) Trial for Anterior Cruciate Ligament (ACL) Repair
Official Title  ICMJE A Multi-Center Open Label Study to Evaluate the SeriACL™ Device (Gen IB) for Primary Anterior Cruciate Ligament Repair
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Anterior Cruciate Ligament Reconstruction
Intervention  ICMJE Device: SeriACL Device ACL Reconstruction
Long-term Bioresorbable ACL Scaffold
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: October 16, 2008)
30
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00775892
Other Study ID Numbers  ICMJE CLN-ACL1B
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rebecca L Horan, PhD, Serica Technologies, Inc.
Study Sponsor  ICMJE Serica Technologies, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hans Paessler, MD ATOS Clinic, Heidelberg
Principal Investigator: Johan Bellemans, MD UZ Leuven, Belgium
Principal Investigator: Holger Schmitt, MD Heidelberg University
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
PRS Account Serica Technologies, Inc.
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP