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Completed

NCT Number: NCT00775892

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

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

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Key information

Conditions

Anterior Cruciate Ligament Reconstruction

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Dr. Pierer Sanatorium, Salzburg, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SeriACL Device ACL Reconstruction

Device

Long-term Bioresorbable ACL Scaffold

Primary outcomes

  1. Safety - Adverse Events

    Time frame: 12 months

  2. KT-1000 Arthrometer Knee Laxity

    Time frame: 12 months

Secondary outcomes

  1. Knee Surveys

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Serica Technologies, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
First posted
Oct 20, 2008
Registry last updated
Aug 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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