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NCT00775892 Clinical Trial

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

Anterior Cruciate Ligament Reconstruction Clinical Trial

Official title:
A Multi-Center Open Label Study to Evaluate the SeriACL™ Device (Gen IB) for Primary Anterior Cruciate Ligament Repair

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00775892
Other study ID # CLN-ACL1B
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received October 16, 2008
Last updated August 7, 2011
Start date September 2008

Study information
Verified date August 2011
Source Serica Technologies, Inc.
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date
Est. primary completion date May 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 55 Years
Eligibility Major 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

Major Exclusion Criteria:

- Prior ACL reconstruction.

- Severe pain, swelling, or redness

- Complete PCL tear

- Complex menisci tears

- Contralateral knee ligament injury

- OA > Grade II

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

  • Anterior Cruciate Ligament Reconstruction

Intervention

Device:
• SeriACL Device ACL Reconstruction
Long-term Bioresorbable ACL Scaffold

Locations
Country Name City State
Austria Dr. Pierer Sanatorium Salzburg
Belgium UZ Leuven Leuven
Germany Dietrich-Bonhöffer-Klinik Altentreptow
Germany Medizinische Hochschule Hannover Hannover
Germany ATOS Clinic Heidelberg
Germany University of Heidelberg Heidelberg

Sponsors (1)
Lead Sponsor Collaborator
Serica Technologies, Inc.

Countries where clinical trial is conducted

Austria,  Belgium,  Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety - Adverse Events 12 months Yes
Primary KT-1000 Arthrometer Knee Laxity 12 months No
Secondary Knee Surveys 12 months No
See also
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