Description of Trial:
Partial Cranial Cruciate Ligament Tears Treated with an Allogenic Amnionic Allograft Administered by Peri-Articular Acupuncture Injection compared to Intra-articular Injection Methods in Dogs. A means to evaluate an alternative treatment for CCL injury in dogs.
Proposed Trial Time Frame:
Date: Coming Soon
A multi center, randomized, masked, placebo-controlled study to demonstrate the effectiveness of an amniotic regenerative medicine treatment in dogs diagnosed with a < 50% Cranial Cruciate Ligament (CCL) tear. Diagnosis of the CCL tear is confirmed by use of a needle arthroscope. This will be a 2-phase study, with the goal in Phase 1 to first evaluate the effectiveness of an amniotic product using the standard intra-articular injection method to treat CCL tear. After the success of Phase 1 study, the Phase 2 study will aim to demonstrate that the less invasive acupuncture (Aqua-AP) or periarticular delivery technique can produce the treatment outcome at least as good as the standard intra-articular injection method.
- Dogs are between 1-13 yrs of age and weigh 30-100 pounds of any breed or gender.
- Dogs referred for the reason of a single rear limb lameness and no other concurrent medical conditions noted within 2 months of clinical trial enrollment.
- Dogs whose owners agree and are open to a less invasive and non-surgical approach to heal a damaged CCL.
- Dogs who have a definitive diagnosis of <50% CCL tear when confirmed under anesthesia with the use of a needle arthroscope.
- Dogs with multi limb lameness and ongoing underlying concurrent metabolic disease.
- Dogs with a >50% CCL tear will need a surgical referral and are NOT a candidate for this trial.
- Dogs currently on immunosuppressive doses of corticosteroids.
- Dogs whose owners are not interested in an alternative CCL therapy to surgical management by TPLO/TTA.
- Dogs whose owners are not willing to allow 2-3 anesthetic procedures using needle arthroscopy to diagnose joint pathology or follow up visits as outlined in the study protocol. Dogs and owners are unable to return for reevaluations at 60, 90, 120 days.
Follow-Up Required for the study:
Required 60, 90, 120 days post treatment.
- (Cost: grant money may be provided as funds are made available). Contact SIVC at (252) 631-5033 ask for Dr. Gerardi DVM CVA CVFT MS-TCVM