Safety and Efficacy of Botulinum Toxin A Injection in Patients With Painful Artificial Knee Arthroplasty (TKA)

Launched by MINNEAPOLIS VETERANS AFFAIRS MEDICAL CENTER · Nov 21, 2006

Keywords

ClinConnect Summary

"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, function and quality of life (QOL), and safety in patients with painful total knee arthroplasty (TKA). Patients will be recruited at the Minneapolis VA Medical Center. Patients will be eligible if they are over age 18, have TKA, have pain ≥6/10 on 0-10 numeric rating scale (NRS) and are not candidates for revision surgery.

The primary outcome is: (1) proportion with clinically meaningful change i...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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