SeriACL™ Device Trial for Anterior Cruciate Ligament (ACL) Reconstruction
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|ClinicalTrials.gov Identifier: NCT00490594|
Recruitment Status : Unknown
Verified October 2008 by Serica Technologies, Inc..
Recruitment status was: Active, not recruiting
First Posted : June 22, 2007
Last Update Posted : October 20, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Anterior Cruciate Ligament Knee Injuries||Device: ACL Reconstruction (SeriACL™ Device)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-Center Open Study to Evaluate the SeriACL™ Device for Primary Anterior Cruciate Ligament Repair|
|Study Start Date :||June 2007|
|Estimated Primary Completion Date :||October 2008|
- Device: ACL Reconstruction (SeriACL™ Device)
- Safety - measured by device related SAEs [ Time Frame: 12 months ]
- KT-1000 Arthrometer [ Time Frame: 12 months ]
- Knee Surveys [ Time Frame: 12 months ]
- Return to Work [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00490594
|Principal Investigator:||Lars Engebretsen, MD||Ullevaal Hospital|
|Principal Investigator:||Hans Paessler, MD||ATOS Clinic, Heidelberg|
|Principal Investigator:||Holger Schmitt, MD||Heidelberg University|