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

August 7, 2011 updated by: Serica Technologies, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Salzburg, Austria
        • Dr. Pierer Sanatorium
  • Belgium
      • Leuven, Belgium
        • UZ Leuven
  • Germany
      • Altentreptow, Germany
        • Dietrich-Bonhöffer-Klinik
      • Hannover, Germany
        • Medizinische Hochschule Hannover
      • Heidelberg, Germany
        • University of Heidelberg
      • Heidelberg, Germany
        • ATOS Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety - Adverse Events
Time Frame: 12 months
12 months
KT-1000 Arthrometer Knee Laxity
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Knee Surveys
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Serica Technologies, Inc.

Investigators

  • Principal Investigator: Johan Bellemans, MD, UZ Leuven, Belgium
  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (ACTUAL)

May 1, 2010

Study Registration Dates

First Submitted

October 16, 2008

First Submitted That Met QC Criteria

October 16, 2008

First Posted (ESTIMATE)

October 20, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 9, 2011

Last Update Submitted That Met QC Criteria

August 7, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CLN-ACL1B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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