The purpose of this clinical trial is to demonstrate the safety and efficacy of the Z-Lig* device for the treatment of ruptured ACL of the knee compared to allograft.
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary performance endpoint:
• KT-1000 (2000) knee laxity (Maximum side to side difference reported in mm
injured vs. non-injured
• Pivot Shift Tests and
• Lachman*s Test
Primary efficacy endpoint: KT-1000 (2000) Knee laxity (Maximum side to side
difference reported in mm injured vs. non-injured
The safety endpoints of this Trial are:
• Incidence of Adverse Events
• Incidence of Adverse Device Effects
• Incidence of Serious Adverse Events
• Incidence of Serious Adverse Device Effects
Secondary outcome
The secondary endpoints of this Trial are:
KT-1000 or 2000
• Value at each time point
IKDC Knee Examination
• Anterior drawer test
• Lachman*s test
• Pivot Shift
• Effusion
IKDC Subjective Knee Evaluation
• Pain
• Function
• SF-36 Health Survey
• Tegner Activity Level Scale
Global Subject Satisfaction
X-ray evaluation of tunnel position and diameter:
• Anteroposterior (AP)
• Posteroanterior (PA)
• Rosenberg Flexion
• Lateral
Magnetic Resonance Imaging (MRI) evaluating biological changes:
• Graft ligamentization
• Graft failure
• Osteitis with tunnel widening
• Synovitis
• Other internal derangement such as meniscal tears and articular cartilage
injury
The tertiary endpoints of this Trial are:
• Healthcare Utilization and Costs
• Return to Work
Background summary
The anterior cruciate ligament (ACL) is the key stabilizer of the knee joint
and is frequently injured in athletic activities. More than 800,000 patients
with damaged ACLs undergo in-patient or out-patient surgical intervention
globally each year. Current surgical techniques consist of either the use of
the patient*s own tissue to reconstruct the ACL (autologous harvest procedures)
or, less frequently, cadaveric tissue grafts (allografts).
All grafting techniques have disadvantages and risks. Reconstruction utilizing
an autologous harvest procedure involves two surgical sites, the primary
operative site and the additional harvest site. The harvest procedure for
reconstruction often results in larger or additional incisions, increased pain,
longer recovery periods and increased morbidity. Cadaveric tissue allografts
offer a limited source of ACL replacement tissue due to the scarcity of
available tissue from young healthy donors. . Variability in tissue quality and
performance is also an issue between donors. The perceived risk of transmission
of hepatitis and other diseases has been another obstacle to the acceptance of
cadaveric tissue.
In an effort to overcome the limitations of both autologous and cadaveric
allograft materials, the use of synthetic and animal-derived tissues has been
investigated. To date, these investigations have led to failure, and there are
currently no effective synthetic materials or animal tissue substitutes
available for widespread use in ACL reconstruction.
Study objective
The purpose of this clinical trial is to demonstrate the safety and efficacy of
the Z-Lig* device for the treatment of ruptured ACL of the knee compared to
allograft.
Study design
This is a multicenter, double-blind, randomised clinical investigation that
will be performed in up to 8 centers. A maximum of 66 patients will be
included. The study will last 2 years for the allograft patients and 5 years
for the Z-Lig patients.
Intervention
50% of the patients will be treated with the Z-Lig device, the remaining
patients will be treated with an allograft.
Study burden and risks
Complications of arthroscopic knee surgery include infection, swelling, and
blood clots in the leg. Complications are unusual after knee arthroscopy, and
while they are cause for concern, knee arthroscopy is considered a low-risk
surgical procedure.
Side-effects of general anaesthesia are feeling sick and vomiting after
surgery, shivering, sore throat, headache, feeling tired and confused for a
couple of days. Serious complications are extremely rare. They include:nerve
damage, damage to teeth, lips or tongue, allergic reactions.
Risks and side effects related to the Z-Lig as reported from a US
Investigational Device Exemption, single center study include the following:
Bruising with discoloration, Blood Urea Nitrogen (BUN) elevation, Baker*s cyst,
Decreased hematocrit & hemoglobin induced by Vioxx®, Fever, General malaise,
Graft rupture/failure, Knee laxity, Knee/tibia swelling with effusion, Limited
knee range of motion, Local incision suture reaction, Muscle injury/damage,
Nerve injury/damage, Pain, Redness, Superficial or deep wound infection,
Surgical knee scar, Synovitis (inflammation of synovial membrane).
Risks related to radiology include the following: Minimal radiation exposure
Allergic Responses to the the Z-Lig may include the following:
A total body (systemic) response with associated hives (skin becomes red and
itchy), Shortness of breath, Fainting, Local tissue response (inflammation) at
the surgical site
Risks involving porcine xenograft tissue include the following:
The Z-Lig is manufactured from porcine (pig) xenograft. There is a risk you
may be sensitive to this product.
The Z-Lig is manufactured and packaged under aseptic conditions and additional
testing is performed throughout the manufacturing process to ensure the
material is free from any infectious agents.
Risks related to the allograft include the following:
Despite rules and regulations for tissue banks regarding processing and
procedures of human tissue, there is still a small potential risk of disease
transmission from using allograft (cadaver) tissue. The tissue bank will make
every effort to eliminate this possibility.
Starcrest Drive 11969
San Antonio TX 78247
US
Starcrest Drive 11969
San Antonio TX 78247
US
Listed location countries
Age
Inclusion criteria
1. Potential Subject is able to provide informed consent and must sign the EC-approved Informed Consent Form,
2. Male or female between the ages of 18-60 years,
3. Skeletally mature as evidenced by closure of the epiphyseal plate on x-ray,
4. Simple ACL insufficiency with no concurrent multi-axial or multi-ligament instabilities or knee dislocations,
5. Diagnosed with an acute or chronic primary ruptured anterior cruciate ligament of the knee documented by:
a) physical exam with positive Lachman*s test or,
b) *5 mm side-to-side difference by KT 1000 (or 2000), 10-20 lb force or,
c) MRI of the affected knee
6. Acute injuries must not exhibit effusion or inflammation,,
7. Pre-Injury Tegner Activity Score <8,
8. If female, for the first 12 months post operative, actively practicing a contraception method, or practicing abstinence, or surgically sterilized, or postmenopausal,
Applicable to Denmark only:
9(a): Fertile women those are not pregnant as demonstrated by a negative pregnancy test at the baseline and prior to surgery and use safe method of contraception. Acceptable contraception methods include: intrauterine devices and hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices, injections with prolonged release).;9(b): Sterilized or infertile Subjects are exempt from the requirement to use contraception. Subjects must have undergone surgical sterilization (hysterectomy or bilateral ovariectomy) or be postmenopausal defined as 12 months or more with no menses prior to enrollment).
9. The contralateral knee is asymptomatic, stable and fully functional,
10. 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,
11. Osteoarthritis of Grade II-III acceptable based on the ICRS scale (no Grade IV prior to baseline) if the treatment does not impact the ACL rehabilitation protocol
12. Subjects requiring a meniscal repair without modification to the rehabilitation protocol.
Exclusion criteria
1. Pregnant based on a positive hCG serum or an in vitro diagnostic test result or breast-feeding,
2. Has osteoarthritis of Grade IV,
3. Require a menisectomy (>50%) or meniscal repairs where the treatment has an impact the ACL rehabilitation protocol,
4. Has inflammatory arthritis determined by history, examination or serology,
5. Has an active or latent infection of the affected knee joint or any other systemic infection currently under treatment or treated with antibiotics within the previous 3 months,
6. Has a history of alcoholism, medication, or intravenous drug abuse, psychosis, has a personality disorder(s), poor motivation, emotional or intellectual issues that would likely make the potential Subject unreliable for the Trial, or any combination of variables in the Principal Investigator*s judgment that would exclude a potential Subject,
7. Clinically documented acute or chronic disease, other than the indication to be treated in this Trial that might affect life expectancy, or make it difficult to interpret the potential Subject*s outcome according to the Protocol (i.e., renal, hepatic, cardiac, endocrine, hematologic, autoimmune, metabolic bone, crystal deposition, severe degenerative joint, neoplastic diseases),
8. Potential Subjects with a medical condition that interferes with their ability to participate in a standardized rehabilitation program,
9. Participated in any other investigational drug or device trial 60 days prior to screening visit or who will receive such a drug or device during the course of this Trial,
10. Any previous autograft or allograft revision ACL surgery to either knee,
11. Complete absence of the meniscus cartilage in the affected knee, documented by MRI,
12. Significant posterior cruciate ligament (PCL) or posterolateral corner ligament injury to the affected knee, documented by examination or MRI,
13. Potential Subjects with a known pork food sensitivity/allergy,
14. Has contraindications for MRI,
15. Has a neuromuscular, neurosensory, or musculoskeletal deficiency that limits the ability to perform objective functional assessment of either knee, such that a Subject experienced polytrauma and/or either lower extremity is immobilized to assess knee stability,
16. Potential Subject who is obese or above a Body Mass Index (BMI) of >40 (BMI =kg/m2). See Appendix D.
17. Treatment for any condition during the same procedure, such as an acute cartilage injury, that will modify the ACL rehabilitation protocol.
18. Subjects who plan to return to competitive sports activities within 9 months post surgery
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 |
|---|---|
| CCMO | NL34648.075.10 |