SeriACL™ Device (Gen IB) Trial for Anterior Cruciate Ligament (ACL) Repair
NCT ID: NCT00775892
Last Updated: 2011-08-09
Study Results
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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COMPLETED
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2008-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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SeriACL Device ACL Reconstruction
Long-term Bioresorbable ACL Scaffold
Eligibility Criteria
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Inclusion Criteria
* Passive flexion \>= 120° and passive extension = contralateral knee
* MCL grade 2 or less
* Pre-injury Tegner score \>= 4
* Informed Consent
Exclusion Criteria
* Severe pain, swelling, or redness
* Complete PCL tear
* Complex menisci tears
* Contralateral knee ligament injury
* OA \> Grade II
18 Years
55 Years
ALL
No
Sponsors
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Serica Technologies, Inc.
INDUSTRY
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
UZ Leuven
Leuven, , Belgium
Dietrich-Bonhöffer-Klinik
Altentreptow, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
ATOS Clinic
Heidelberg, , Germany
University of Heidelberg
Heidelberg, , Germany
Countries
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Other Identifiers
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CLN-ACL1B
Identifier Type: -
Identifier Source: org_study_id
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