CLOSED-Trial for dogs with cranial cruciate ligament rupture receiving tibial plateau leveling osteotomy (TPLO)-CLOSED
Evaluation of Fortetropin to reverse disuse muscle atrophy in dogs after tibial plateau leveling osteotomy for cranial cruciate ligament rupture.
Purpose and Brief Description:
Cranial cruciate ligament rupture is a very common injury in active, large-breed dogs. The chronic lameness that occurs because of knee pain from the injury causes rapid and severe muscle atrophy due to disuse of the leg. Tibial plateau leveling osteotomy, or TPLO, is often the best surgical procedure for repairing the ruptured ligament.
Fortetropin is a freeze-dried fertilized egg yolk product that acts in the body to reduce myostatin, a protein produced by the body that inhibits muscle cell growth and proliferation. Fortetropin can be easily mixed into your dog’s food.
This clinical trial will evaluate whether supplementing Fortetropin in your dog’s normal diet after TPLO surgery prevents muscle atrophy, and perhaps improves the rate of muscle mass increase after surgery or shortens the time to resolution of the lameness.
- Dogs diagnosed with cranial cruciate ligament rupture, whose owners have elected for tibial plateau leveling osteotomy (TPLO).
- Must weigh between 18kgs - 60kgs (40lbs-132lbs)
- Must be otherwise healthy with no concurrent disease identified by physical exam or blood work prior to enrollment.
What does enrollment into this trial involve?
Initially, dogs will be evaluated with physical examination, blood work and radiographs to determine if they are eligible to participate in the study. If eligible, prior to TPLO surgery and with your consent, your dog will have additional blood drawn for serum myostatin measurement, measurements taken with a tape measure of thigh circumference of the hind limbs, ultrasound measurement of the back muscle and the thigh muscles, and have lameness measured on a commercial Stance Analyzer, which requires the dog to stand still for a few seconds on a weight-scale like device. Your dog will then be scheduled for and receive TPLO surgery as recommended by your surgeon. The normal hospital stay after surgery is 1-2 nights. Upon release from the hospital, you will be provided Fortetropin or a placebo to add to your dog’s food. Neither you nor the surgeon will know which supplement your pet is receiving. It is important to follow directions for the supplement and make sure your dog eats all of it at each meal. Mixing the Fortetropin or placebo with canned food is acceptable to facilitate complete ingestion.
At 8 weeks after surgery, the normal post-surgical recheck time to assess healing of the TPLO, your dog will return to KSU VHC for postoperative radiographs. For study purposes, blood will again be drawn for serum myostatin measurement, and repeated measurements of thigh and back muscle measurements and repeated lameness measurement will occur. An additional recheck at 12 weeks is requested to repeat these same study measurements.
Once your dog is enrolled, the study covers the costs of the Fortetropin supplement as well as the study recheck visits at 8 and 12 weeks post TPLO surgery (rechecks includes physical exam, sedation, and postoperative radiographs to assess TPLO healing.) The costs of initial examination and radiographs, TPLO surgery, and hospitalization are the responsibility of the owner.
For more information, contact Misty Bear, Clinical Trials Coordinator:
Phone: (785)532-3046, email: ClinicalTrials@vet.k-state.edu