Status:
COMPLETED
Safety and Efficacy of Botulinum Toxin A Injection in Patients With Painful Artificial Knee Arthroplasty (TKA)
Lead Sponsor:
Minneapolis Veterans Affairs Medical Center
Collaborating Sponsors:
University of Minnesota
Arthritis Foundation
Conditions:
Knee Pain
Eligibility:
All Genders
Phase:
PHASE2
Brief 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, pr...
Detailed Description
"This 6-month randomized, placebo-controlled, double blind trial will compare a single intra-articular (IA) injection of 100 units of Botulinum Toxin A (BoNT/A) to placebo for improvement in pain, fun...
Eligibility Criteria
Inclusion
- Male or female subjects, 18 years of age or older.
- Written informed consent and written authorization for use or release of health and research study information have been obtained.
- Subject has chronic Prosthetic knee joint pain for more than 3 months.
- Subject has pain 6 or greater on a 10 point Numerical Pain Rating scale
- Ability to follow study instructions and likely to complete all required visits.
- Negative urine pregnancy test on the day of treatment prior to the administration of study medication (for females of childbearing potential). (if applicable)
- Negative infectious etiology workup (joint aspiration, serological parameters such as Erythrocyte Sedimentation Rate (ESR) or C-reactive protein (CRP) and clinical examination).
- Patients who were considered not to be candidates for Prosthetic knee joint revision surgery and have failed traditional treatments including oral pain medications, as determined by referring orthopedic surgeon
Exclusion
- Use of aminoglycoside antibiotics, curare-like agents, or other agents that might interfere with neuromuscular function.
- Any medical condition that may put the subject at increased risk with exposure to BOTOX ®including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or known disorders of neuromuscular function
- Females who are pregnant, breast-feeding, or planning a pregnancy during the study or who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study.
- Know allergy or sensitivity to any of the components in the study medication.
- History of recent or ongoing alcohol or drug abuse.
- Known, uncontrolled systemic disease.
- Concurrent participation in another research study
- Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
- Patients whose pain is rated as less than 6 on a 10 point Numerical Pain Rating scale at the screening visit
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00403273
Start Date
July 1 2006
End Date
January 1 2009
Last Update
May 21 2018
Active Locations (1)
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1
Minneapolis VA Medical Center
Minneapolis, Minnesota, United States, 55417