Purpose
The purpose of this study is to compare the effectiveness of cemented versus cementless canine total knee replacement.
Background
In this study, we would like to perform a side-by-side comparison of two
types of canine total knee replacement (TKR) implant, one of which is a
standard implant that is secured to bone with bone cement, while the
other is intended for use without bone cement ("cementless fixation").
Cementless fixation has a long and successful history in human joint
replacement, and we have been using cementless hip replacements at OSU
for several years in dogs, with excellent clinical results. We have no
reason to believe that a cementless TKR will behave any differently to a
cemented TKR, and the safety of the cementless implant has been
established in a research study that we performed at OSU. However, there
are no published reports on the effectiveness of cementless canine TKR
in clinical patients. In the research study that we have designed, your
dog will be randomized to receive either a cemented TKR implant or a
cementless TKR implant. The surgical procedure will be the same, except
for minor changes that relate only to insertion of the implant with or
without cement. Post-operative care will be exactly the same for both
cemented and cemented TKR animals. Recovery times are expected to be the
same for the two groups.
Inclusion Criteria
To qualify for enrollment in this study, dogs must have either:
- Skeletally mature dogs with moderate to severe arthritis of the
knee joint and clinical signs of pain and/or lameness that are not
significantly improved by the use of joint supplements (e.g.
glucosamine-chondroitin sulfate, Adequan), non-steroidal
anti-inflammatory drugs (e.g. Rimadyl, Deramaxx) or other standard
medical treatments.
Study Design/Treatment Schedule
The overall goal of this study is to document clinical function and the
long-term performance of the implant. Clinical function will be assessed
at 6, 12, 26 and 52 weeks through clinical examinations supplemented by
the use of a computerized force platform that allows us to document how
much your dog is using each leg after surgery, objectively assessing
his/her degree of lameness. We will assess bone healing using standard
X-rays and a bone mineral density scan (essentially, a modified X-ray).
The additional procedures that are required will not pose a significant
risk to your dog. No additional drugs will be administered since we will
collect our data while your animal is under sedation for regular
radiographs routinely taken during recheck evaluations.
We would like to follow your animal for the duration of his/her normal
lifespan. Our goal is to develop a TKR implant that lasts the duration
of the animal's life. The interval between the time of TKR surgery and
any subsequent revision surgery (if needed) will be used as a measure of
implant survival. If the implant lasts for the duration of your
animal's life, or if a second surgery is needed to replace the implant,
we would ask that you provide us with an opportunity to examine the
retrieved implant so that we can evaluate the implant for evidence of
mechanical wear or damage.
Client Compensation
- The implants for this study will be provided at no cost; as a
result, the cost of TKR performed under this clinical trial will be
$4,500 to $5,000 (a saving of $1,000 over the standard cost of TKR).
Client Cost
- The owner is responsible for all standard fees associated with TKR
surgery and post-operative assessments, including office visits and
examinations.
Contact
Dr. Matthew Allen, e-mail, for further
information.