Clinical trials are research studies that determine the safety and effectiveness of a treatment, device or medical strategy. Clinical trials allow diseases and their treatments to be studied organically rather than simulated in a laboratory environment. These trials follow strict scientific standards that produce reliable results while also protecting the patient.
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 short-term clinical performance and safety of an anatomically pre-contoured, locking plate with or without internal brace in dogs with complete, acute 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.
This is a randomized, controlled clinical trial. This means that patients will be randomly assigned to either a control group or the “treatment” group. All patients (control or treatment) will received a standard TPLO with a previously established safe and effective TPLO plate. Patients assigned to the “treatment” group will also have an internal brace. Patient evaluation, surgery, postoperative care and follow-up assessment will otherwise be the same for all patients regardless of group assignment and will follow typical standard of care for patients having TPLO surgery.
- Dogs of any breed and sex. All dogs must be between 1 to 10 years of age.
- Dogs with acute, complete rupture of the CrCL (as diagnosed on physical exam by an orthopedic surgeon)
- Dogs that can return for follow-up examinations at 6, 12 weeks, and 6 months postoperatively
- Dogs with unilateral lameness caused by CrCL insufficiency (dogs with contralateral CrCL deficient stifle previously operated more than 6 months prior the study, will also be included)
- Clients must be able to commit to study recheck guidelines:
- Rechecks are scheduled at 6 weeks, 12 weeks and 6 months post-operatively.
- At each recheck appointment, sedated radiographs of the knee will be taken and a full orthopedic exam will be performed.
- 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 radiographic evaluation (at 6 weeks and 6 months) at no charge (approximately $600 with sedation)
- A $200 reimbursement will be made 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