To assess performance and safety of L-C Ligament® against autograft surgery with hamstring tendon for primary ACL reconstruction.
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety:
The primary safety endpoint is defined as absence of revision surgery for graft
failure. A subject is a responder (success) if at 12 months post-procedure the
patient has not undergone revision surgery due to graft failure (tear/rupture,
loss of fixation, infection, etc).
Performance:
The primary performance endpoint is based on IKDC Subjective Evaluation scores.
A subject is a responder (success) if at 12 months post-procedure the patient
has an overall IKDC Subjective Evaluation score improvement of * 12 points over
baseline.
Secondary outcome
SECONDARY ENDPOINTS:
The following variables will be characterized for both groups:
* Numeric Pain Scores at Day 1 post-procedure
* AE/SAE rates at all follow-up time points
ADDITIONAL ANALYSES:
The following will also be reported at available study timepoints:
* Subjective outcomes (Lysholm score, Tegner Score, KOOS Score)
* Clinical outcomes (Lachman, Anterior drawer, Pivot-shift, single-leg hop
test)
* Instrumented testing outcomes (KT1000)
* MRI outcomes
* Other Imaging outcomes (CT, X-Ray)
* Health Economics (Procedure time, hospitalization duration, complication
rates, medications, recovery duration, time to return to work, quality of life,
etc)
Background summary
The anterior cruciate ligament (ACL) is one of the most important ligaments of
the knee. Along with the other knee ligaments, the two menisci, cartilage and
muscl,e the anterior cruciate ligament ensures the stability of the knee joint.
The stability is necessary for the proper functioning of the knee in everyday
life and during the performance of sports. The anterior cruciate ligament
ensures that the lower leg relative to the upper leg is prevented from sliding
too far and cannot rotate too far. A damaged ligament is usually perceived as
"going through the knee" and is often accompanied by a snapping sound. Usually
the knee will swell.
In this study we want to investigate the performance and safety of L-C Ligament
on long term (5 years). In addition, the study will compare performance and
safety profiles for the two groups (comparator being autograft surgery with
hamstring tendon).
The LC ligament is a three-dimensional (3-D) braided support made of a fiber
(PLLA), a material that is resorbed by the body. The PLLA material whose LC
ligament is made, has a long and successful history (over 15 years) as a
biological material in many implants for orthopedic and sports medicine use.
Study objective
To assess performance and safety of L-C Ligament® against autograft surgery
with hamstring tendon for primary ACL reconstruction.
Study design
This is a multicenter, randomised clinical investigation that will be performed
in maximum 6 centers. 60 (2:1 - L-C ligament vs autograft)
patients will be included. The study will last 5 years for the patients.
Intervention
ACL reconstruction with the L-C ligament or autograft.
Study burden and risks
An arthroscopy is a very safe procedure during which complications occur only
rarely. The possible complications include: severe and long-term swelling,
bleeding in the knee, damage to nerves in the skin, and, very rarely,
inflammation of the joint. These risks are also present for every other type of
reconstruction to the anterior cruciate ligament.
Adverse effects associated with general anaesthesia include: drowsiness,
nausea, sore throat and hoarseness. Rare complications include:
hypersensitivity reactions to the medications administered during the procedure
and injury to the nerves.
As L-C Ligament is an experimental device, some of the risks associated with it
are not yet known. Possible risks associated with the L-C Ligament device
include, but are not limited to:
The known risks are listed below
* Allergic reaction to device / materials
* Pain or discomfort caused by device failure
* Inflammation
* Instability in your knee caused by device failure
* Infection caused by reaction to the device
* Persistent effusion
* Cyst formation
* Premature uptake by the body
* Delay in recovery and/or abnormal healing of your ACL
The risks of autograft surgery with your hamstring tendon include, but are not
limited to:
* Weakness and/or loss of endurance of the hamstring muscles
* Pain in the back of your knee
* Infection
* Instability in your knee
* Vascular Injury
* Hematoma (collection of blood outside the blood vessels)
* Chronic hamstring strain with pain
* If your harvested hamstring is too short, then your patella tendon might be
harvested
Anticipated risks associated with any ACL reconstruction procedure not specific
to the L-C Ligament or hamstring autograft include, but are not limited to:
* Allergic reaction to medication
* Bone fracture
* Cyclops lesion
* Deep vein thrombosis (blood clot in your legs)
* Effusion (Excess fluid build-up)
* Graft failure
* Hardware removal
* Hematoma (collection of blood outside the blood vessels)
* Infection
* Instability in your knee
* Nerve Injury
* Pain
* Pulmonary Embolism
* Soft Tissue Injury
* Stiffness in the joints
* Swelling / bruising
* Vascular Injury
The amount of radiation to which you will be exposed will normally not differ
from that of other endoscopic procedures, and should therefore not place the
subject at any increased risk.
Pregnant women will be excluded from participation in this study. This
restriction applies to the entire study period. Women of childbearing
potential should therefore take reliable measures to prevent getting pregnant
during the study.
Benefits
There is no guarantee that you will benefit from participating in the study The
study treatment may lead to improvement or no improvement, or the condition may
worsen. It is expected that the reconstruction operation of the anterior
cruciate ligamentwill reduce the pain , and improves the functioning of the
knee joint.
It is thanks to this type of research that better treatments for torn anterior
cruciate ligament can be developed.
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Listed location countries
Age
Inclusion criteria
* Signed Informed Consent
* 18 to 45 years of age
* Closed tibial and femoral physes
* 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 requires reconstruction of the ACL. Reconstruction surgery must occur within 18 weeks (126 days) of injury
* Passive flexion * 120° and passive extension on the target knee is the same as the contralateral knee
* If a concomitant Medial Collateral Ligament (MCL) injury is present: grade 2 or less
* Baseline IKDC Subjective Evaluation score * 70
* Willing to not participate in sports for a minimum of 9 months post-procedure
* Physically and mentally willing and able to comply with post-operative rehabilitation and routinely scheduled clinical, radiographic and rehabilitation follow up visits through 60 months.
Exclusion criteria
* Prior ACL reconstruction or other surgical procedure on the affected (target) ACL
* Chronic ACL injury; interventional surgery scheduled 127 days or more after ACL injury
* Professional athletes currently engaged in active sport
* Baseline Tegner score *9
* Prior distal femoral and/or proximal tibial fracture(s) of the target leg
* Previous or current ACL injury on contra-lateral leg
* Multi-ligament reconstruction
* Malalignment or varus thrust
* Patient > 193 cm tall (6* 4*)
* Confirmed connective tissue disorder
* Signs of moderate to severe degenerative joint disease (such as osteoarthritis), including ICRS Score of 3 or 4
* Presence of cartilage defects that requires a surgical intervention other than microfracture technique
* Severe pain, swelling, or redness within 24 hours prior to surgery
* Complete or partial Post Cruciate Ligament (PCL) tear
* If a concomitant meniscal tear is present, any of the following: (a) the meniscal tear is not repairable in the clinical judgement of the Investigator; (b) *1/3 meniscal resection required; (c) complex double-bucket tear; (d) previously partially repaired tears; (d) previously partially repaired tears; (e) other meniscus injury that may negatively impact the function of the ACL
* Additional concomitant injuries to the knee or lower extremities requiring treatment, per surgeon's discretion, that are not allowable under the Inclusion criteria
* The patient is mentally compromised
* The patient has a neuromuscular disorder that would endanger unacceptable risk of knee instability, prosthesis fixation failure, or complications in postoperative care
* 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 * 35
* The patient has a known allergy to PLLA
* The patient has a medical condition, including metabolic bone disease (e.g., osteoporosis or rickets), crystal deposition disease (e.g., gout), inflammatory joint disease (e.g., rheumatoid arthritis), known neoplastic disease, 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 | NCT02183727 |
| CCMO | NL49825.075.14 |