ruptured anterior cruciate ligament
Conditions
Interventions
50% of the patients will be treated with the Z-Lig device, the remaining
patients will be treated with an allograft.
Sponsors
Aperion Biologics Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
Exclusion criteria
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary performance endpoint: • KT-1000 (2000) knee laxity (Maximum side to side difference reported in mm injured vs. non-injured | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Netherlands
Outcome results
None listed