Status:
COMPLETED
SeriACL™ Device (Gen IB) Trial for Anterior Cruciate Ligament (ACL) Repair
Lead Sponsor:
Serica Technologies, Inc.
Conditions:
Anterior Cruciate Ligament Reconstruction
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- Major
- 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
- Prior ACL reconstruction.
- Severe pain, swelling, or redness
- Complete PCL tear
- Complex menisci tears
- Contralateral knee ligament injury
- OA \> Grade II
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00775892
Start Date
September 1 2008
Last Update
August 9 2011
Active Locations (6)
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1
Dr. Pierer Sanatorium
Salzburg, Austria
2
UZ Leuven
Leuven, Belgium
3
Dietrich-Bonhöffer-Klinik
Altentreptow, Germany
4
Medizinische Hochschule Hannover
Hanover, Germany