CLINICAL TRIAL FOR DOGS WITH ACUTE CRANIAL CRUCIATE LIGAMENT INJURIES

VSH is currently enrolling patients with relatively acute, complete cranial cruciate ligament ruptures in a clinical trial to evaluate the performance of a tibial plateau leveling osteotomy (TPLO) procedure with the addition of an internal brace.

Overview: The purpose of the study is to evaluate the safety and short-term clinical performance of an anatomically pre-contoured, locking plate with internal brace in dogs that have complete CrCL insufficiency. The internal brace is comprised of a bone anchor and braided suture that is anchored to the tibia using a novel TPLO plate.  The purpose of this suture is to limit internal rotation of the knee joint to provide additional stability of the joint.  The decision to place this additional suture may be made prior to or during surgery by the primary investigator (surgeon).

Patient Eligibility:  

  1. Dogs of any breed and sex. All dogs must be between 1 to 10 years of age.
  2. Procedure must include the locking plate augmented with internal brace.
  3. Dimensions of the tibia should allow use of 3.5mm small, standard or broad TPLO plate.
  4. Dogs with complete rupture of the CrCL. Complete CrCL is defined based on physical examination finding of a palpable cranial drawer in both flexion and extension (approximately more than 5 mm)
  5. Dogs that can return for follow-up examinations at 2, 4 and 8 weeks, and 6 months postoperatively
  6. Clients must be able to commit to study recheck guidelines:
    1. Required study rechecks are scheduled at 8 weeks and 6 months post-operatively. Additionally, our standard protocol is to see patients at 2 and 4 weeks postoperatively for suture removal and early assessment.
    2. At the 8 week and 6 month recheck appointments, sedated radiographs of the knee will be taken and a full orthopedic exam will be performed.
    3. Clients will also be asked to complete a short questionnaire in order to assess patient progress.

Why Participate in a Clinical Trial?

Clinical trials help evaluate new medical techniques and can help change and improve medical treatment options provided to veterinary patients.  Benefits of this particular clinical trial include:

  • Minimally invasive joint evaluation (arthroscopy) at no additional cost (typically this is an additional $300 to the standard TPLO cost)
  • Additional examination and radiographic evaluation at 6 months at no charge (normally $425 with sedation)
  • Internal brace implants are provided at no charge (approximately $4-500)
  • A $200 reimbursement will be made to the client at the final recheck (6 months) if all recheck and follow up has been completed per study protocol.

For more information or to discuss patient eligibility, please contact Brian Trumpatori, DVM, DACVS at 919.233.4911 or Heather Mahmoud (Surgery service coordinator) at 919.600.6621