NCT00775892CompletedPhase 1
A Multi-Center Open Label Study to Evaluate the SeriACL™ Device (Gen IB) for Primary Anterior Cruciate Ligament Repair
Serica Technologies, Inc.7 sites in 3 countries30 target enrollmentStarted: September 1, 2008Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 7
- Primary Endpoint
- Safety - Adverse Events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Prior ACL reconstruction.
- •Severe pain, swelling, or redness
- •Complete PCL tear
- •Complex menisci tears
- •Contralateral knee ligament injury
- •OA > Grade II
Outcomes
Primary Outcomes
Safety - Adverse Events
Time Frame: 12 months
KT-1000 Arthrometer Knee Laxity
Time Frame: 12 months
Secondary Outcomes
- Knee Surveys(12 months)
Investigators
Study Sites (7)
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