SeriACL™ Device Trial for Anterior Cruciate Ligament (ACL) Reconstruction

A Multi-Center Open Study to Evaluate the SeriACL™ Device for Primary Anterior Cruciate Ligament Repair

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00490594

Enrollment

Registered

2007-06-22

Start date

2007-06-30

Completion date

Unknown

Last updated

2008-10-20

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

Conditions

Anterior Cruciate Ligament, Knee Injuries

Keywords

ACL, ligament, ACL injury

Brief summary

The SeriACL device was developed as an alternative to an autograft (i.e., tissue that is taken from a patient's own body) or an allograft (i.e., tissue that is taken from a cadaver) for ACL reconstruction. The SeriACL device is made of silk yarns, knit and processed with SeriCoat™ surface treatment which makes it easier to wet the material. The SeriACL device is designed to be a temporary support structure to replace the torn ACL and to stabilize the knee joint following surgical repair. It is designed to use the body's own healing process to regenerate the patient's own new ligament tissue. As the new tissue grows and the support structure is needed less over time, the SeriACL device is bioresorbed (i.e., broken down) by the patient's body. The SeriACL device is designed to be installed with standard surgical techniques for ACL repair. This study is designed to test the safety of the SeriACL device in primary total ACL repair in patients with a torn ACL. The study will evaluate whether repair of the ACL with the SeriACL device will return the knee to normal function and what, if any, side effects will occur.

Interventions

DEVICEACL Reconstruction (SeriACL™ Device)

Bioresorbable ACL

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Inclusion criteria

* Complete ACL rupture * Injured knee range of motion \>= 75% of contralateral knee * MCL tear grading \<= 2 * Sign informed consent.

Exclusion criteria

* Prior ACL reconstruction * Complete PCL tear * Locked bucket handle tear or complex tears of the menisci. * Contralateral knee ligament injury * Known joint disease * Known allergy to silk * Active drug or alcohol abuse * Pregnant

Design outcomes

Primary

Measure	Time frame
Safety - measured by device related SAEs	12 months
KT-1000 Arthrometer	12 months

Secondary

Measure	Time frame
Knee Surveys	12 months
Return to Work	12 months

Countries

Germany, Norway

Outcome results

None listed

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