SeriACL™ Device (Gen IB) Trial for Anterior Cruciate Ligament (ACL) Repair
Phase 1
Completed
- Conditions
- Anterior Cruciate Ligament Reconstruction
- Registration Number
- NCT00775892
- Lead Sponsor
- Serica Technologies, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Safety - Adverse Events 12 months KT-1000 Arthrometer Knee Laxity 12 months
- Secondary Outcome Measures
Name Time Method Knee Surveys 12 months
Trial Locations
- Locations (6)
UZ Leuven
🇧🇪Leuven, Belgium
ATOS Clinic
🇩🇪Heidelberg, Germany
University of Heidelberg
🇩🇪Heidelberg, Germany
Dietrich-Bonhöffer-Klinik
🇩🇪Altentreptow, Germany
Dr. Pierer Sanatorium
🇦🇹Salzburg, Austria
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany