Safety and Efficacy of Botulinum Toxin A Injection in Patients With Painful Artificial Knee Arthroplasty (TKA)
Status:
Completed
Trial end date:
2009-01-01
Target enrollment:
Participant gender:
Summary
Primary Total Knee joint replacement surgery is highly successful surgery for relieving pain
and improving function in patients with disabling arthritis. Unfortunately, like all
biomedical devices, prosthesis failure is a complication of knee replacement surgery that
leads to disabling pain, stiffness and loss of function. Approximately 1% of the knee
replacements fail every year leading to a 20% failure rate over 20 years. The common causes
of failure of prosthetic joint are infection, loosening, trauma or wear of the prosthesis.
Currently, a revision surgery is the best option for long term pain relief (analgesics or
other pain medications are options but are of limited benefit). Surgery may not be feasible
in patients due to advancing age, other medical conditions and surgical/technical
difficulties or patient's choice. In addition, the results from revision surgery are not as
good as the initial knee joint surgery. Therefore, there is a great need for a novel,
targeted therapy that provides an option to patients who are unfit, unable, or unwilling to
undergo surgery.
In the investigators' recent pilot study, a single injection of Botulinum toxin A (Botox) in
painful natural knee, ankle and shoulder joints of patients with various types of arthritis
led to significant and durable improvement in pain and function and was safe to use. The
investigators propose this 6-month study to compare pain relief, improvement of function and
safety of an injection of Botulinum toxin compared to placebo in patients with a painful
prosthetic knee joint. Both patients and investigators will be blinded to the treatment
assignment to a patient until the study is completed. The investigators will assess the
amount and duration of pain relief, improvement in function and short term safety of
Botulinum toxin using standard validated measures. Patients will be evaluated at baseline, 2
weeks, 1-, 2-, 3-, 4- and 6-months after a single injection of either placebo or BoNT/A in
the hip or knee prosthesis. The six-month follow-up is to assess the duration of meaningful
pain relief. If successful, this will offer a new treatment option for patients with a
chronically painful knee prosthetic joint, provide more insight into the origin and cause of
pain in prosthetic joints and direct future investigations in new directions.
Phase:
Phase 2
Details
Lead Sponsor:
Minneapolis Veterans Affairs Medical Center
Collaborators:
Arthritis Foundation University of Minnesota University of Minnesota - Clinical and Translational Science Institute
Treatments:
abobotulinumtoxinA Botulinum Toxins Botulinum Toxins, Type A incobotulinumtoxinA onabotulinumtoxinA