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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00775892

Enrollment

Registered

2008-10-20

Start date

2008-09-30

Completion date

Unknown

Last updated

2011-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Reconstruction

Keywords

ACL, Ligament

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.

Interventions

DEVICESeriACL Device ACL Reconstruction

Long-term Bioresorbable ACL Scaffold

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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 Major

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Safety - Adverse Events	12 months
KT-1000 Arthrometer Knee Laxity	12 months

Secondary

Measure	Time frame
Knee Surveys	12 months

Countries

Austria, Belgium, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026