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Clinical Trials/NCT00775892
NCT00775892
Completed
Phase 1

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

Serica Technologies, Inc.6 sites in 3 countries30 target enrollmentSeptember 2008
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ConditionsAnterior Cruciate Ligament Reconstruction

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Anterior Cruciate Ligament Reconstruction
Sponsor
Serica Technologies, Inc.
Enrollment
30
Locations
6
Primary Endpoint
Safety - Adverse Events
Status
Completed
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

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.

Registry
clinicaltrials.gov
Start Date
September 2008
End Date
May 2010
Last Updated
14 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Serica Technologies, Inc.

Eligibility Criteria

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)

Study Sites (6)

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