Clinical Evaluation of a Resorbable PLLA Implant for Regeneration of the Anterior Cruciate Ligament (ACL)

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

June 30, 2013

Primary Completion Date

March 31, 2019

Study Completion Date

December 31, 2019

Conditions
Complete Tear, Knee, Anterior Cruciate Ligament
Interventions
DEVICE

L-C Ligament

The L-C Ligament is a bioresorbable, three-dimensional (3-D) braided scaffold made from poly L-lactic acid (PLLA) fiber. One device is used to replace the ACL. The L-C Ligament is an interventional device. The L-C Ligament is comprised of three regions: (1) The femoral tunnel attachment site, (2) The ligament region (intra-articular zone), and (3) The tibial tunnel attachment site. For several months after surgery, the L-C Ligament replaces the function of the ACL. During this time, ligament tissue regenerates within and around the L-C Ligament, which is slowly absorbed and replaced by the ACL.

Trial Locations (2)

30033

Martini ziekenhuis, Groningen

Unknown

Isala Klinieken - locatie Weezenlanden, Zwolle

All Listed Sponsors
lead

Soft Tissue Regeneration, Inc.

INDUSTRY

NCT01634711 - Clinical Evaluation of a Resorbable PLLA Implant for Regeneration of the Anterior Cruciate Ligament (ACL) | Biotech Hunter | Biotech Hunter