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

Serica Technologies, Inc.30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Anterior Cruciate Ligament Reconstruction

Interventions

SeriACL Device ACL ReconstructionDEVICE

Long-term Bioresorbable ACL Scaffold

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (6)

Dr. Pierer Sanatorium

Salzburg, Austria

UZ Leuven

Leuven, Belgium

Dietrich-Bonhöffer-Klinik

Altentreptow, Germany

Medizinische Hochschule Hannover

Hanover, Germany

Outcomes

Primary Outcomes

Safety - Adverse Events

Time frame: 12 months

KT-1000 Arthrometer Knee Laxity

Time frame: 12 months

Secondary Outcomes

Knee Surveys

Time frame: 12 months

Data from ClinicalTrials.gov

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