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

Anterior Cruciate Ligament Reconstruction

Intervention / Treatment

Device: SeriACL Device ACL Reconstruction

Study Type

Interventional

Enrollment (Anticipated)

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

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