MedDataX Logo

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

NCT ID: NCT00490594

Last Updated: 2008-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anterior Cruciate Ligament Knee Injuries

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

ACL ligament ACL injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ACL Reconstruction (SeriACL™ Device)

Bioresorbable ACL

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Serica Technologies, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Serica Technologies, Inc.

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lars Engebretsen, MD

Role: PRINCIPAL_INVESTIGATOR

Ullevaal Hospital

Hans Paessler, MD

Role: PRINCIPAL_INVESTIGATOR

ATOS Clinic, Heidelberg

Holger Schmitt, MD

Role: PRINCIPAL_INVESTIGATOR

Heidelberg University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Atos Clinic

Heidelberg, , Germany

Site Status

Heidelberg University

Heidelberg, , Germany

Site Status

Ullevaal Hospital

Oslo, , Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany Norway

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CLN-ACL1

Identifier Type: -

Identifier Source: org_study_id