Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01634711 |
| Other study ID # |
LC 1033, Version 3.0 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 1/Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
June 2013 |
| Est. completion date |
December 2019 |
Study information
| Verified date |
November 2021 |
| Source |
Soft Tissue Regeneration, Inc. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to evaluate the safety of a resorbable polymer implant (Soft
Tissue Regeneration's L-C Ligament) for replacement and regeneration of the anterior cruciate
ligament (ACL). Approximately 15 patients at 2-3 different hospitals in Europe will
participate in this study. The hypothesis of this study is that the L-C Ligament will
successfully regenerate the ACL with clinical outcomes similar to or better than surgical
intervention with auto graft tissue.
Description:
Reconstruction of the ACL is currently recommended as the standard of care following an ACL
tear or rupture. The ACL has poor healing potential and repair of the damaged tissue is
rarely successful. The gold standard for reconstruction of the ACL is autograft tissue, with
the patellar and hamstring tendons the most common. The limitations of autograft are donor
site morbidity and pain, and potential damage of the remaining tissue at the harvest site.
Other problems include a limited amount of tendon available for harvesting, unpredictable
resorption characteristics, and increased recovery time. Allografts are tissues such as
patellar, hamstring, and Achilles tendons obtained from cadavers. The advantages of surgery
with allograft are less pain and scarring, decreased surgical time, and faster
rehabilitation. However, allografts can transmit disease, may elicit an unfavorable
immunogenic response, and incorporate slower than autograft. Also, allografts cannot be
sterilized without damaging the tissue, leading to a choice between a risk of bacterial
infection and decreased tensile strength and healing potential.
The proposed study is a prospective, consecutive, non-randomized, multicentre clinical trial
conducted at up to five European sites, wherein 15 study subjects will undergo primary ACL
reconstruction with the L-C Ligament. After screening procedures are completed, eligible
study subjects who provide written informed consent will be enrolled in the study. Subjects
will undergo preoperative clinical, MRI, and radiographic evaluations and undergo primary ACL
reconstruction. Follow-up clinical evaluations will be performed post-op (range 1-8 weeks), 3
months (± 3 weeks), 6 months (± 3 weeks), 12 months (± 1 month), and 24 months (± 2 months)
after surgery. Assessment of safety (i.e., assessment of adverse events and complications),
pain, and clinical function as well as imaging will occur.
In accordance with a separate radiographic protocol, analysis and scoring of MRI images
(pre-op, 1 and 2 years), radiographs (pre- and post- op), and a CT scan post-op and at 1-year
will be undertaken by an independent radiologist who will be masked to the identities of the
subjects and clinical investigators. Outcome measures for imaging include position of the
bone tunnels and interference screws, indirect evidence of ligament tissue remodeling, and
evidence of tunnel-widening. Evidence of OA will also be monitored. The Principal
Investigator and Co-Investigators will ensure that complications observed on radiographs,
MRI, and CT images are reported to their ethics committee and the sponsor.
The primary objective of this study is to evaluate the safety of the L-C Ligament in primary
ACL reconstruction. Safety will be evaluated by the occurrence, frequency, and severity of
intra- and post- operative complications; the primary end point is one year and follow-up wil
be performed for a minimum of two years. Clinical function will be assessed with the
IKDC-2000 Scale and functionality of the device at two years follow-up.
The secondary objectives of this study are to determine efficacy by objectively and
subjectively measuring pain, function, and the results of image analyses of the L-C Ligament
in primary ACL reconstruction. Objective measures include the Lachman test, the anterior
drawer test, the KT-1000 Arthrometer, the pivot-shift test, and the single-leg hop test. Pre-
and post- operative objective and subjective measures include the Tegner and Lysholm scales.
Pre- and post- op radiographs, MRI images pre-op, and at 1 and 2 years, and post-op and
1-year CT scans will be analyzed for position of the bone tunnels and screws, indirect
evidence of ligament tissue remodeling, and evidence of widening of the bone tunnels.
