A Prospective and Consecutive Clinical Evaluation of Soft Tissue Regeneration*s L-C Ligament® in Primary ACL Reconstructio
- Conditions
- ruptured anterior cruciate ligament10043237
- Registration Number
- NL-OMON53168
- Lead Sponsor
- Biorez, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
18 to 45 years of age.
Males and females.
If female, for the 24 months post-operative, actively practicing a
contraception method, or surgically sterilised or
postmenopausal.
Acute unilateral ACL tear, or partial or complete tear of the ACL
that occurred within 91 days (13 weeks) of injury, and requires
reconstruction of the ACL.
Passive flexion - 120° and passive extension on the target knee
is the same as the contralateral knee.
Patients with all types of lateral and/or medial meniscal tears
which are repairable.
Medial Collateral Ligament (MCL) grade 2 or less.
Potential Subject is able to provide informed consent and must
sign the EC-approved Informed Consent Form
Must be physically and mentally willing and able to comply with
post-operative rehabilitation and routinely scheduled clinical,
radiographic and rehabilitation follow up visits through 24
months.
Prior ACL reconstruction or other surgical procedure on the
affected (target) knee.
Chronic ACL injury; interventional surgery scheduled 92 days or
more after ACL injury.
Professional athletes currently engaged in active sport
Prior fracture of the affected (target) leg
Previous or current ACL injury on contra-lateral leg.
Multi-ligament reconstruction.
Malalignment with varus thrust
Patient > 193 cm tall (6* 4*).
The patient does not follow pre-operative rehabilitation.
Confirmed connective tissue disorder.
Signs of moderate to severe degenerative joint disease
(Osteoarthritis)
Concomitant injuries to the knee or lower extremities requiring
treatment, per surgeon's discretion.
Severe pain, swelling, or redness within 24 hours prior to
surgery.
Complete or partial Post Cruciate Ligament (PCL) tear.
Any of the following: 1/3rd meniscal resection; complex doublebucket
tear; partially repaired meniscal tears.
Patient requires treatment of articular cartilage on target leg
The patient is mentally compromised.
The patient has a neuromuscular disorder that would engender
unacceptable risk of knee instability, prosthesis fixation failure,
or complications in postoperative care.
The patient has a diagnosed systemic disease that would affect
his/her safety or the study outcome.
The patient has an active or latent infection in or about the
affected knee joint or an infection site distant from the knee that
may spread to the knee hematogenously.
Pregnant based on a positive beta hCG serum or an in vitro
diagnostic test result or breast-feeding.
The patient is obese with a BMI ³ 35.
The patient has a known allergy to PLLA.
The patient has a medical condition or comorbidity that would
interfere with study participation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>* Absence of graft failure (attributed to the device) at one year<br /><br>* Absence of revision ACL surgery at one year post-procedure<br /><br>required due to any of the following:<br /><br>* Tear or rupture in the graft<br /><br>* Serious infection attributed to the L-C Ligament<br /><br>* Substantial laxity attributed to loss of fixation in the femoral<br /><br>or tibial tunnels directly attributed to the L-C Ligament</p><br>
- Secondary Outcome Measures
Name Time Method <p>The following variables will be analyzed for informational purposes:<br /><br>- Clinical function as assessed by the 2000 IKDC scale at pre-op, post-op, 3,<br /><br>6, 12, 18 and 24 months.<br /><br>- Safety rates per intra- and post- operative complications.<br /><br>- KOOS Pain, Tegner and Lysholm scores pre-op, post-op, 3, 6, 12, 18 and 24<br /><br>months and 3 ,4 and 5 years.<br /><br>- Radiographic, MRI, and CT assessment of the position of the femoral & tibial<br /><br>tunnels, indirect evidence of ligament tissue remodeling, and evidence of<br /><br>tunnel-widening.<br /><br>- Clinical function measured with the Lachman, anterior drawer, KT1000*,<br /><br>pivot-shift, and single-leg hop tests at pre-op, 6, 12, 18 and 24 months (and<br /><br>optionally at Years 3, 4, and 5).</p><br>