Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00152347
Status:
COMPLETED
Last Update Posted:
2018-05-17
First Post:
2005-09-07
Brief Title:
A Double-Blind Randomized Control Trial Comparing Botulinum Toxin Type A Botox and Placebo in the Treatment of Idiopathic Clubfoot
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
A Double-Blind Randomized Control Trial Comparing Botulinum Toxin Type A Botox and Placebo in the Treatment of Idiopathic Clubfoot
Status:
COMPLETED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to continue the work from the previous review study and determine the effectiveness of Botox in treating patients with idiopathic clubfoot by comparing outcomes of subjects treated with manipulation and casting plus Botox treatment group to those treated with manipulation and casting plus placebo control group
The null hypothesis is that manipulation and casting plus Botox is not an effective treatment for idiopathic clubfoot The alternate hypothesis is that manipulation and casting plus Botox is an effective treatment for idiopathic clubfoot
The null hypothesis is that manipulation and casting plus Botox is not an effective treatment for idiopathic clubfoot The alternate hypothesis is that manipulation and casting plus Botox is an effective treatment for idiopathic clubfoot
Detailed Description:
The study timeline is divided into five phases which have been defined based on experiences with the previous review and with clubfoot treatment in general These phases are as follows 1 study treatment Botox injection versus placebo 2 post-treatment manipulation and casting 3 bracing and full-time maintenance 4 intent-to-treat intervention for management of first-time non-responders NR1 and first-time recurrences Rec1 post-study treatment and 5 rescue intervention for management of second-time non-responders NR2 and second-time recurrences Rec2 post intent-to-treat intervention
We will utilize a double-blind randomized control trial to assess the efficacy of Botox in the treatment of idiopathic clubfoot Patients parents both participating surgeons and members of their clinical and research teams physiotherapist occupational therapist orthopaedic technologist orthotist research assistant will be blinded to the study group Botox group versus control group each subject belongs in The pharmacist preparing the syringes for injection will not be blinded
Subjects will be randomly assigned to receive either Botox Treatment group or placebo injection Control group Subjects in the treatment group will receive Botox injections dosed at 10 IUkg prepared by diluting 100 IU of Botox in 1cc of unpreserved saline If the child has bilateral clubfoot the contents will be divided equally for injection into each gastrocnemius Placebo injections for the control group will contain unpreserved saline at 01cckg such that a 45 kg subject will receive 045cc
We will utilize a double-blind randomized control trial to assess the efficacy of Botox in the treatment of idiopathic clubfoot Patients parents both participating surgeons and members of their clinical and research teams physiotherapist occupational therapist orthopaedic technologist orthotist research assistant will be blinded to the study group Botox group versus control group each subject belongs in The pharmacist preparing the syringes for injection will not be blinded
Subjects will be randomly assigned to receive either Botox Treatment group or placebo injection Control group Subjects in the treatment group will receive Botox injections dosed at 10 IUkg prepared by diluting 100 IU of Botox in 1cc of unpreserved saline If the child has bilateral clubfoot the contents will be divided equally for injection into each gastrocnemius Placebo injections for the control group will contain unpreserved saline at 01cckg such that a 45 kg subject will receive 045cc
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None