Personalized, Bioreplaceable Endoprosthesis to Perform Limb Sparing in Dogs

Trial closed July 2022.

Patient Disease:

Canine Osteosarcoma

Study Name:

Purpose of the study:

To evaluate the use of a personalized 3D-printed implant made of a material that the body can replace with its own bone in limb sparing surgery in dogs with osteosarcoma

Primary Eligibility Criteria:

Dogs with suspected or confirmed osteosarcoma of the distal radius that meets previously established limb sparing eligibility criteria
Weight >20 kg (44 lb) and < 85 kg (187 lb)
Dogs must be free of detectable metastasis, and in good health otherwise
No prior definitive radiation therapy to the primary bone tumor

Study Protocol:

Following entry into the study, dogs will have a CT scan of the affected limb prior to surgery
The images obtained with the CT scan will be used to make the 3D-printed implants that will be used in the limb-sparing surgical procedure
Two weeks after surgery, dogs will begin carboplatin chemotherapy, administered every three weeks for a total of 6 treatments
Follow-up bloodwork, orthopedic exams, gait analyses, and chest and limb x-rays will be performed at various points throughout the chemotherapy protocol and every 2 months thereafter until 18 months post-op, then every 4 months indefinitely

Owner Responsibilities:

You are responsible for the initial testing to determine study eligibility and any other tests recommended by your pet’s oncologist
You are responsible for the costs of chemotherapy and treatment of any complications of surgery or side effects of chemotherapy, as well as the costs associated with the surgical procedure that are not covered by the trial
You are expected to make and keep all appointments associated with the study

Financial Incentives:

The study will cover the costs of the CT to plan the personalized implant (including anesthesia), the personalized implant with the growth factor for bone, the special instruments required to do the surgery and the metal implants
The costs of the recheck visits with the x-rays of the operated limb and chest (every 2 months) will also be covered by the study for one year after the surgery
A $1,000 credit to your VTH account will be provided to help cover the cost of the surgery

If you have further questions about any of our clinical trials, please submit an online consult form. Your consult will then be directed to our trials team. Requests are typically returned within 5 business days.