The primary objective of this study is to evaluate the safety of the L-C Ligament in primary ACL reconstruction. The secondary objectives of this study are to evaluate pain, function, and radiographic performance of the L-C Ligament in primary ACL…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* Absence of graft failure (attributed to the device) at one year
* Absence of revision ACL surgery at one year post-procedure
required due to any of the following:
* Tear or rupture in the graft
* Serious infection attributed to the L-C Ligament
* Substantial laxity attributed to loss of fixation in the femoral
or tibial tunnels directly attributed to the L-C Ligament
Secondary outcome
The following variables will be analyzed for informational purposes:
- Clinical function as assessed by the 2000 IKDC scale at pre-op, post-op, 3,
6, 12, 18 and 24 months.
- Safety rates per intra- and post- operative complications.
- KOOS Pain, Tegner and Lysholm scores pre-op, post-op, 3, 6, 12, 18 and 24
months and 3 ,4 and 5 years.
- Radiographic, MRI, and CT assessment of the position of the femoral & tibial
tunnels, indirect evidence of ligament tissue remodeling, and evidence of
tunnel-widening.
- Clinical function measured with the Lachman, anterior drawer, KT1000*,
pivot-shift, and single-leg hop tests at pre-op, 6, 12, 18 and 24 months (and
optionally at Years 3, 4, and 5).
Background summary
Injury of the anterior cruciate ligament (ACL) is a common occurrence in the
young adult population. An estimated 250.000 ACL reconstructions are performed
annually in the USA with more than 300.000 in the developed international
market. The incidence of this injury is roughly 1 in 3000 per year. ACL injury
has immediate and long-term consequences, which include increased risk for
osteoarthritis and long-term disability.
The ACL has poor healing potential. Chronic tears and ruptures are usually
treated with autograft or allograft.
The design of the L-C Ligament is intended to eliminate the morbidity
associated with autograft, negates the risk of disease transmission and
variability in quality associated with allograft, and should provide similar or
improved healing and clinical function compared to allo- and auto- graft
tissues. The objective of this investigation is to evaluate safety, pre- and
post-operative pain, and clinical function of the L-C Ligament.
Study objective
The primary objective of this study is to evaluate the safety of the L-C
Ligament in primary ACL reconstruction.
The secondary objectives of this study are to evaluate pain, function, and
radiographic performance of the L-C Ligament in primary ACL reconstruction.
Study design
This is a multicenter clinical investigation that will be performed in maximum
3 centers. 15
patients will be included. The study will last 5 years for the patients.
Intervention
ACL reconstruction with the L-C ligament.
Study burden and risks
Every medical procedure carries risks with it. Since the LC ligament an
investigational medical device , some risks are unknown.
An arthroscopy is a very safe procedure with rare complications. Possible
complications include: sharp and prolonged swelling, bleeding in the knee,
damaged skin nerve, and very rarely arthritis. These risks are similar to any
other reconstruction procedure of the anterior cruciate ligament.
Side effects of general anesthesia may include: drowsiness, nausea, sore throat
/ or hoarseness. Rare complications include: hypersensitivity reactions to the
drugs used during anesthesia and nerve injury.
Potential risks associated with the use of this medical device, which we do not
expect to occur, include: loosening, failure of fixation failure or wear,
premature or delayed resorption by the body, delayed healing and / or abnormal
recovery from your ACL. These risks are similar to other treatment options for
reconstruction of the anterior cruciate ligament, such as the use of allogeneic
and autogenous tissue.
The amount of X-rays which one is exposed to, is normally not greater than
during keyhole surgery procedures and would not increase the risk.
Pregnant women are excluded from this study. This applies to the entire study.
Women of childbearing age should therefore take proper measures to avoid
becoming pregnant during the study. The doctor will discuss with the subject,
before they consent to participate in the study, the most appropriate
contraceptive measures . If the subject, despite all precautions, does become
pregnant during the study, she will be asked to contact the investigator /
treating doctor immediately. It is not known what the consequences of
participation in the study for the unborn child are.
Benefits
It is expected that the reconstruction of the anterior cruciate ligament
surgery ensures that the pain decreases, and enhances the functioning of the
knee joint. However, it is possible that the subject does not experience
benefits.
It is thanks to this type of research that better treatments for torn anterior
cruciate ligament can be developed.
Church Street, 17th Floor 195
New Haven Suite 206
US
Church Street, 17th Floor 195
New Haven Suite 206
US
Listed location countries
Age
Inclusion criteria
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.
Exclusion criteria
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01634711 |
| CCMO | NL41298.075.12 |