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

NCT00490594 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2008-10-20

No results posted yet for this study

Summary

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.

Conditions

  • Anterior Cruciate Ligament
  • Knee Injuries

Interventions

DEVICE

ACL Reconstruction (SeriACL™ Device)

Bioresorbable ACL

Sponsors & Collaborators

  • Serica Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Lars Engebretsen, MD · Ullevaal Hospital

  • Hans Paessler, MD · ATOS Clinic, Heidelberg

  • Holger Schmitt, MD · Heidelberg University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2008-10-31

Countries

  • Germany
  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00490594 on ClinicalTrials.gov