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NCT00403273 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Botulinum Toxin A Injection in Patients With Painful Artificial Knee Arthroplasty (TKA)
A Phase 2 study, sponsored by Minneapolis Veterans Affairs Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 54
- Enrollment target
NCT00403273 is a Phase 2 study that has completed, run by Minneapolis Veterans Affairs Medical Center. The registered enrollment target is 54 participants.
The verdict
NCT00403273, a Phase 2 study, has completed, sponsored by Minneapolis Veterans Affairs Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 54 participants
- Enrollment target
Study 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
Interventions
- DRUG Normal Saline
- DRUG Botulinum toxin A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2006-07 |
| Est. Completion | 2009-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00403273
The ClinicalTrials.gov registry entry for NCT00403273 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Minneapolis Veterans Affairs Medical Center, which has 28 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Normal Saline is the first listed.
NCT00403273 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00403273 about?
NCT00403273 is a clinical study titled "Safety and Efficacy of Botulinum Toxin A Injection in Patients With Painful Artificial Knee Arthroplasty (TKA)". 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, stiffne...
What is the current status of trial NCT00403273?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2006-07. Estimated completion is 2009-01.
What interventions are being tested in trial NCT00403273?
The interventions under investigation include: Normal Saline (DRUG), Botulinum toxin A (DRUG).
Who is sponsoring clinical trial NCT00403273?
This trial is sponsored by Minneapolis Veterans Affairs Medical Center, which has 28 total clinical trials registered on ClinicalTrials.gov.
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