Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001433796
Ethics application status
Approved
Date submitted
3/11/2022
Date registered
8/11/2022
Date last updated
6/03/2023
Date data sharing statement initially provided
8/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Arthroscopic Stiff Elbow release and Botox
Scientific title
The Effect of Postoperative Administration of Botox vs Placebo (Normal Saline) on Elbow Range of Motion in Patients Undergoing Arthroscopic Osteocapsular Release for Patients with Elbow Contracture: A Pilot Triple-Blind Randomized Controlled Trial
Secondary ID [1] 308315 0
None
Universal Trial Number (UTN)
U1111-1284-5107
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Elbow Contracture 328098 0
Condition category
Condition code
Musculoskeletal 325154 325154 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The dependent variable (intervention) will be 100 units of Botulinum toxin reconstituted with 2 cc of Normal Saline, introduced using a one-off intramuscular injection into the bifurcation of the biceps in the upper arm and the brachialis at the level of the elbow joint, under ultrasound guidance by the anesthetist postoperatively, at the time when the anesthetist inserts a pain catheter for postoperative pain control for patients undergoing arthroscopic osteocapsular release for elbow contractures. As this trial aims compare the effect of a one-off administration of the intervention (botulinum toxin reconstituted with normal saline) compared to a one-off administration of a placebo (normal saline only) pre-surgery, adherence to the intervention is not applicable.
All other processes of arthroscopic osteocapsular release for elbow contractures will occur as per usual standard care.
Intervention code [1] 324766 0
Treatment: Drugs
Comparator / control treatment
The control (placebo) will be 2 cc of Normal Saline, in a one-off intramuscular injection into the bifurcation of the biceps in the upper arm and the brachialis at the level of the elbow joint, under ultrasound guidance by the anesthetist postoperatively, at the time when the anesthetist inserts a pain catheter for postoperative pain control. for patients undergoing arthroscopic osteocapsular release for elbow contractures.
Control group
Placebo

Outcomes
Primary outcome [1] 332978 0
Elbow flexion and extension range of motion will be assessed by a blinded member of the study team, who will take photographs of the elbow in maximal active flexion and maximal active extension from the lateral (side) view.
Computer-based software will then be used to assess the range of motion in and flexion-extension.
Timepoint [1] 332978 0
Preoperatively, and at 3, 6, and 12 months postoperatively
Primary outcome [2] 332979 0
Elbow supination and pronation range of motion will be assessed by a blinded member of the study team, who will take photographs of the patient from the anterior (front) view, with the patient holding straight markers in both hands in maximal active pronation and maximal active supination.
Computer-based software will then be used to assess the range of motion in and pronation-supination.
Timepoint [2] 332979 0
Preoperatively, and at 3, 6, and 12 months postoperatively
Secondary outcome [1] 415409 0
Mayo Elbow Performance Index
Timepoint [1] 415409 0
Preoperatively, and at 3, 6, and 12 months postoperatively
Secondary outcome [2] 415410 0
Oxford Elbow Score
Timepoint [2] 415410 0
Preoperatively, and at 3, 6, and 12 months postoperatively

Eligibility
Key inclusion criteria
Patient complains of elbow stiffness, end of range of motion pain, and/or mechanical symptoms consistent with a mechanical block to range of motion.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with past history of botulism, peripheral neuropathy, or myasthenia gravis.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomization
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
To achieve study objectives, ten patients are needed in the intervention group, and ten patients in the control group.

Wilcoxon signed-rank test will be used to compare outcomes at different timepoints within the same group.

Mann Whitney U tests will be used to compare outcomes at the same timepoints between the intervention and control groups.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/11/2022
Actual
15/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 312560 0
Other
Name [1] 312560 0
Orthocentre
Country [1] 312560 0
Australia
Primary sponsor type
Individual
Name
John Trantalis
Address
Orthocentre, 86 Kareena Rd, Caringbah, NSW 2229
Country
Australia
Secondary sponsor category [1] 314167 0
Individual
Name [1] 314167 0
Jehan Hamid
Address [1] 314167 0
Orthocentre, 86 Kareena Rd, Caringbah, NSW 2229
Country [1] 314167 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311889 0
Ramsay Health Care New South Wales | Victoria Human Research Ethics Committee
Ethics committee address [1] 311889 0
Ramsay Health Care NSW | VIC HREC
Ramsay Health Care
Level 7, Tower B
7 Westbourne Street
St Leonards NSW 2065
Ethics committee country [1] 311889 0
Australia
Date submitted for ethics approval [1] 311889 0
31/03/2022
Approval date [1] 311889 0
10/04/2022
Ethics approval number [1] 311889 0
HREC Reference Number: 2021-1010

Summary
Brief summary
This pilot study aims to compare patient-rated outcomes and range of motion between patients who undergo surgical stiff elbow release, treated with an injection of botulinum toxin (botox) pre-surgery vs placebo.

We hypothesized that the injection of botox into the biceps and brachialis immediately before surgery may result in greater range of motion (less stiffness) following surgical release.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122730 0
Dr John Trantalis
Address 122730 0
Orthocentre, 86 Kareena Rd, Caringbah, NSW 2229
Country 122730 0
Australia
Phone 122730 0
+61 2 9525 2055
Fax 122730 0
Email 122730 0
research@shoulderandelbow.com.au
Contact person for public queries
Name 122731 0
Dr John Trantalis
Address 122731 0
Orthocentre, 86 Kareena Rd, Caringbah, NSW 2229
Country 122731 0
Australia
Phone 122731 0
+61 2 9525 2055
Fax 122731 0
Email 122731 0
research@shoulderandelbow.com.au
Contact person for scientific queries
Name 122732 0
Dr John Trantalis
Address 122732 0
Orthocentre, 86 Kareena Rd, Caringbah, NSW 2229
Country 122732 0
Australia
Phone 122732 0
+61 2 9525 2055
Fax 122732 0
Email 122732 0
research@shoulderandelbow.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
After de-identification, patient age at time of surgery, sex, range of motion in elbow flexion, extension, supination, and pronation, and Mayo Elbow Performance Index and Oxford Elbow Scores.
When will data be available (start and end dates)?
Start date: Immediately following publication
End date: No end date
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor and Principal Investigator (upon reasonable request).
Available for what types of analyses?
Any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator (research@shoulderandelbow.com.au)


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.