SeriACL™ Device Trial for Anterior Cruciate Ligament (ACL) Reconstruction

October 17, 2008 updated by: Serica Technologies, Inc.

A Multi-Center Open Study to Evaluate the SeriACL™ Device for Primary Anterior Cruciate Ligament Repair

The SeriACL device was developed as an alternative to an autograft (i.e., tissue that is taken from a patient's own body) or an allograft (i.e., tissue that is taken from a cadaver) for ACL reconstruction. The SeriACL device is made of silk yarns, knit and processed with SeriCoat™ surface treatment which makes it easier to wet the material. The SeriACL device is designed to be a temporary support structure to replace the torn ACL and to stabilize the knee joint following surgical repair. It is designed to use the body's own healing process to regenerate the patient's own new ligament tissue. As the new tissue grows and the support structure is needed less over time, the SeriACL device is bioresorbed (i.e., broken down) by the patient's body. The SeriACL device is designed to be installed with standard surgical techniques for ACL repair.

This study is designed to test the safety of the SeriACL device in primary total ACL repair in patients with a torn ACL. The study will evaluate whether repair of the ACL with the SeriACL device will return the knee to normal function and what, if any, side effects will occur.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Device: ACL Reconstruction (SeriACL™ Device)

Study Type

Interventional

Enrollment (Anticipated)

Phase

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

Germany
- - Heidelberg, Germany
    - Heidelberg University
  - Heidelberg, Germany
    - ATOS Clinic
Norway
- - Oslo, Norway
    - Ullevaal Hospital

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

14 years to 41 years (Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Complete ACL rupture
Injured knee range of motion >= 75% of contralateral knee
MCL tear grading <= 2
Sign informed consent.

Exclusion criteria:

Prior ACL reconstruction
Complete PCL tear
Locked bucket handle tear or complex tears of the menisci.
Contralateral knee ligament injury
Known joint disease
Known allergy to silk
Active drug or alcohol abuse
Pregnant

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: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety - measured by device related SAEs Time Frame: 12 months	12 months
KT-1000 Arthrometer Time Frame: 12 months	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Knee Surveys Time Frame: 12 months	12 months
Return to Work 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: Lars Engebretsen, MD, Ullevaal Hospital

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

June 1, 2007

Primary Completion (Anticipated)

October 1, 2008

Study Registration Dates

First Submitted

June 20, 2007

First Submitted That Met QC Criteria

June 21, 2007

First Posted (Estimate)

June 22, 2007

Study Record Updates

Last Update Posted (Estimate)

October 20, 2008

Last Update Submitted That Met QC Criteria

October 17, 2008

Last Verified