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

Serica Technologies

Status and phase: Completed; Phase 2; Phase 1

Conditions: Anterior Cruciate Ligament Reconstruction

Treatments: Device: SeriACL Device ACL Reconstruction

Study type: Interventional

Funder types: Industry

Identifiers

NCT00775892

CLN-ACL1B

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Major Exclusion Criteria:

• Prior ACL reconstruction.
• Severe pain, swelling, or redness
• Complete PCL tear
• Complex menisci tears
• Contralateral knee ligament injury
• OA > Grade II

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)