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

NCT ID: NCT00775892

Last Updated: 2011-08-09

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Brief Summary

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

Detailed Description

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Conditions

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Anterior Cruciate Ligament Reconstruction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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SeriACL Device ACL Reconstruction

Long-term Bioresorbable ACL Scaffold

Intervention Type DEVICE

Eligibility Criteria

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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

Exclusion Criteria

* Prior ACL reconstruction.
* Severe pain, swelling, or redness
* Complete PCL tear
* Complex menisci tears
* Contralateral knee ligament injury
* OA \> Grade II
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Serica Technologies, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Serica Technologies, Inc.

Principal Investigators

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Hans Paessler, MD

Role: PRINCIPAL_INVESTIGATOR

ATOS Clinic, Heidelberg

Johan Bellemans, MD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven, Belgium

Holger Schmitt, MD

Role: PRINCIPAL_INVESTIGATOR

Heidelberg University

Gerhard Oberthaler, MD

Role: PRINCIPAL_INVESTIGATOR

Dr. Pierer Sanatorium, Salzburg, Austria

Uwe Pietzner, MD

Role: PRINCIPAL_INVESTIGATOR

Dietrich-Bonhöffer-Klinik, Altentreptow, Germany

Michael Jagodzsinki, MD

Role: PRINCIPAL_INVESTIGATOR

Hannover Medical School

Locations

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Dr. Pierer Sanatorium

Salzburg, , Austria

Site Status

UZ Leuven

Leuven, , Belgium

Site Status

Dietrich-Bonhöffer-Klinik

Altentreptow, , Germany

Site Status

Medizinische Hochschule Hannover

Hanover, , Germany

Site Status

ATOS Clinic

Heidelberg, , Germany

Site Status

University of Heidelberg

Heidelberg, , Germany

Site Status

Countries

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Austria Belgium Germany

Other Identifiers

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CLN-ACL1B

Identifier Type: -

Identifier Source: org_study_id

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