ruptured anterior cruciate ligament
Conditions
Interventions
ACL reconstruction with the L-C ligament or autograft.
ACL reconstruction
Anterior cruciate ligament (ACL)
Synthetic device
Sponsors
Biorez Inc.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Austria, Germany, Hungary, Ireland, Netherlands
Outcome results
None listed