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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00490594
Other study ID # CLN-ACL1
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received June 20, 2007
Last updated October 17, 2008
Start date June 2007

Study information

Verified date October 2008
Source Serica Technologies, Inc.
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 45 Years
Eligibility 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
ACL Reconstruction (SeriACL™ Device)
Bioresorbable ACL

Locations

Country Name City State
Germany Atos Clinic Heidelberg
Germany Heidelberg University Heidelberg
Norway Ullevaal Hospital Oslo

Sponsors (1)

Lead Sponsor Collaborator
Serica Technologies, Inc.

Countries where clinical trial is conducted

Germany,  Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety - measured by device related SAEs 12 months Yes
Primary KT-1000 Arthrometer 12 months No
Secondary Knee Surveys 12 months No
Secondary Return to Work 12 months No
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