Unequal Length of Limbs; CongenitalPhase 3BOLLDNCT00412035
Botox Injection for Lower Extremity Lengthening and Deformity Correction Surgery
A Phase 3 study testing Botulinum toxin A injection and saline injection in people with Unequal Length of Limbs; Congenital and Lower Extremity Deformities, Congenital, run by Shriners Hospitals for Children at 6 sites in 2 countries.
Trial summary
The purpose of this six site multi-center study is to determine if BTX-A can alleviate the post-operative pain and improve the functional and quality of life outcomes of children with limb length discrepancy or angular deformity undergoing limb lengthening or deformity correction. Read more about this study
- Who is it for?
- Ages 5 to 21 years
- Conditions the study is for
- Unequal Length of Limbs; Congenital, Lower Extremity Deformities, Congenital
- What is being tested?
- Botulinum toxin A injection and saline injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Jan 2007to Dec 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age: 5 to 21 years.
- Aetiology of the deformity: congenital or acquired.
- Amount of lengthening or deformity correction: any amount.
- Site of lengthening or deformity correction: lower extremity.
- Type of fixator: circular or uniplanar.
Who cannot join
- Children younger than 5 years of age.
- Associated neuromuscular conditions that may hinder weight bearing.
- Individuals on aminoglycosides, as aminoglycosides can potentiate the effect of Botulinum toxin A.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States4 sites
Shriners Hospital for Children
Honolulu, Hawaii, 96826-1099
Shriners Hospital for Children
Philadelphia, Pennsylvania, 19140
Shriners Hospital for Children
Portland, Oregon, 97239-3095
Alfred I.duPont Hospital for Children
Wilmington, Delaware, 19899
Canada2 sites
Shriners Hospital for Children
Montreal, Quebec, H3G 1A6
The Hospital for Sick Children
Toronto, Ontario, M5g 1X8
About this study
Official title: Safety and Efficacy of Botox Injection in Alleviating Post-Operative Pain and Improving Quality of Life in Lower Extremity Limb Lengthening and Deformity Correction
The purpose of this six site multi-center study is to determine if BTX-A can alleviate the post-operative pain and improve the functional and quality of life outcomes of children with limb length discrepancy or angular deformity undergoing limb lengthening or deformity correction.
Read the detailed description
The specific aims are to determine if BTX-A will:
- 1a. Reduce pain post operatively and during the distraction and consolidation process,
- 1b. Reduce the amount, frequency and duration of narcotics taken in the postoperative period.
- 2. Improve the quality of life during the distraction and consolidation process.
- 3 Decrease muscular spasm and subsequent muscle contracture during the distraction and consolidation process and accelerate earlier return to pre-operative mobility function including earlier weight bearing.
- 4. To develop clinical practice guidelines for the interdisciplinary care of children undergoing limb lengthening or deformity correction.
Methodology: A randomization process for this one time injection will be used to determine who will receive the BTX-A or the placebo. 150 subjects will be recruited; 75 to the BTX-A group and 75 to the placebo group. There will be an equal number of subjects in each group at each site. The medication will be injected intraoperatively into specific major muscles in the lower limb adjacent to the bone or soft tissue being lengthened or corrected at a dose of 10 U/kg with a maximum of 50 U per site, not to exceed a total maximum dose of 400 units. Pain scores, medication dosages, range of motion and an ambulation scale will be measured post-operatively and during the distraction and consolidation phases.
In addition families will be asked to complete six different questionnaires related to pain, quality of life and psycho-social issues at various times during the process. The children will receive standard nursing care and physical therapy and will be followed for three months after the external fixator is removed, for a total time of approximately one year.
- Being tested
- Botulinum toxin A injection, saline injection
- Medical subject headings
- Lower Extremity Deformities, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin A injectionDrug
Also called botox
10 units per kilo to maximum of 400 units
saline injectionDrug
Also called salt water
10 units per kilo to maximum of 400 units
| Study group | Role | What they receive |
|---|---|---|
| Botox | Active comparator | Botulinum toxin A injection Receives: Drug: Botulinum toxin A injection |
| Placebo | Placebo comparator | saline injection Receives: Drug: saline injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
average pain scores in 1st 4 days post op
Measured: 1st 4 days post op
total amount of narcotic used in 1st 4 days post op
Measured: 1st 4 days post op
Secondary outcomes (4)
Quality of life (PedsQL)
Measured: pre-op, mid distractionm end distraction, pre frame removal, 3 months post frame removal
Active and passive range of motion
Measured: pre-op, mid distractionm end distraction, pre frame removal, 3 months post frame removal
Muscle strength
Measured: pre-op, mid distractionm end distraction, pre frame removal, 3 months post frame removal
Ambulation scores (FAQ)
Measured: pre-op, mid distractionm end distraction, pre frame removal, 3 months post frame removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2006 (estimated)
- Study startJan 2007
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Unequal Length of Limbs; CongenitalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shriners Hospitals for Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reggie Hamdy, MD, Shriners Hospitals for Children
- Investigators
- Reggie Hamdy, MD, Principal investigator, Shriners Hospital for Children-Canadian Unit, Montreal, Quebec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00412035
- Sponsor's protocol ID
- 9142
- Acronym
- BOLLD
- Status last verified
- Dec 2014
- First submitted
- 13 Dec 2006
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hamdy RC, Montpetit K, Ruck-Gibis J, Thorstad K, Raney E, Aiona M, Platt R, Finley A, Mackenzie W, McCarthy J, Narayanan U. Safety and efficacy of botox injection in alleviating post-operative pain and improving quality of life in lower extremity limb lengthening and deformity correction. Trials. 2007 Sep 28;8:27. doi: 10.1186/1745-6215-8-27.
PubMed 17903262Montpetit K, Hamdy RC, Dahan-Oliel N, Zhang X, Narayanan UG. Measurement of health-related quality of life in children undergoing external fixator treatment for lower limb deformities. J Pediatr Orthop. 2009 Dec;29(8):920-6. doi: 10.1097/BPO.0b013e3181c1e2e2.
PubMed 19934710Hamdy RC, Montpetit K, Raney EM, Aiona MD, Fillman RR, MacKenzie W, McCarthy J, Chafetz RS, Thomas SS, Tamayo CM, Littleton AG, Ruck-Gibis J, Takahashi SN, Rinaldi M, Finley GA, Platt RW, Dahan-Oliel N. Botulinum toxin type A injection in alleviating postoperative pain and improving quality of life in lower extremity limb lengthening and deformity correction: a pilot study. J Pediatr Orthop. 2009 Jul-Aug;29(5):427-34. doi: 10.1097/BPO.0b013e3181aad628.
PubMed 19568011
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Botox Injection in Alleviating Post-Operative Pain and Improving Quality of Life in Lower Extremity Limb Lengthening and Deformity Correction
- ClinicalTrials.gov ID
- NCT00412035
- Acronym / sponsor ID
- BOLLD / 9142
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Shriners Hospitals for ChildrenUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 15 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this six site multi-center study is to determine if BTX-A can alleviate the post-operative pain and improve the functional and quality of life outcomes of children with limb length discrepancy or angular deformity undergoing limb lengthening or deformity correction.
Detailed description
The specific aims are to determine if BTX-A will:
- 1a. Reduce pain post operatively and during the distraction and consolidation process,
- 1b. Reduce the amount, frequency and duration of narcotics taken in the postoperative period.
- 2. Improve the quality of life during the distraction and consolidation process.
- 3 Decrease muscular spasm and subsequent muscle contracture during the distraction and consolidation process and accelerate earlier return to pre-operative mobility function including earlier weight bearing.
- 4. To develop clinical practice guidelines for the interdisciplinary care of children undergoing limb lengthening or deformity correction.
Methodology: A randomization process for this one time injection will be used to determine who will receive the BTX-A or the placebo. 150 subjects will be recruited; 75 to the BTX-A group and 75 to the placebo group. There will be an equal number of subjects in each group at each site. The medication will be injected intraoperatively into specific major muscles in the lower limb adjacent to the bone or soft tissue being lengthened or corrected at a dose of 10 U/kg with a maximum of 50 U per site, not to exceed a total maximum dose of 400 units. Pain scores, medication dosages, range of motion and an ambulation scale will be measured post-operatively and during the distraction and consolidation phases.
In addition families will be asked to complete six different questionnaires related to pain, quality of life and psycho-social issues at various times during the process. The children will receive standard nursing care and physical therapy and will be followed for three months after the external fixator is removed, for a total time of approximately one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botox | Active comparator | Drug: Botulinum toxin A injectionBotulinum toxin A injection |
| Placebo | Placebo comparator | Drug: saline injectionsaline injection |
Who may qualify
- Ages
- 5 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age: 5 to 21 years.
- Aetiology of the deformity: congenital or acquired.
- Amount of lengthening or deformity correction: any amount.
- Site of lengthening or deformity correction: lower extremity.
- Type of fixator: circular or uniplanar.
Key exclusion criteria (3 listed)
- Children younger than 5 years of age.
- Associated neuromuscular conditions that may hinder weight bearing.
- Individuals on aminoglycosides, as aminoglycosides can potentiate the effect of Botulinum toxin A.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin A injectionAlso: botox10 units per kilo to maximum of 400 units | Drug | Botox |
| saline injectionAlso: salt water10 units per kilo to maximum of 400 units | Drug | Placebo |
Primary outcome
average pain scores in 1st 4 days post op
Time frame: 1st 4 days post op
total amount of narcotic used in 1st 4 days post op
Time frame: 1st 4 days post op
4 secondary outcomes
Quality of life (PedsQL)
Time frame: pre-op, mid distractionm end distraction, pre frame removal, 3 months post frame removal
Active and passive range of motion
Time frame: pre-op, mid distractionm end distraction, pre frame removal, 3 months post frame removal
Muscle strength
Time frame: pre-op, mid distractionm end distraction, pre frame removal, 3 months post frame removal
Ambulation scores (FAQ)
Time frame: pre-op, mid distractionm end distraction, pre frame removal, 3 months post frame removal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2014.
- Background: PubMed 17903262Hamdy RC, Montpetit K, Ruck-Gibis J, Thorstad K, Raney E, Aiona M, Platt R, Finley A, Mackenzie W, McCarthy J, Narayanan U. Safety and efficacy of botox injection in alleviating post-operative pain and improving quality of life in lower extremity limb lengthening and deformity correction. Trials. 2007 Sep 28;8:27. doi: 10.1186/1745-6215-8-27.
- Background: PubMed 19934710Montpetit K, Hamdy RC, Dahan-Oliel N, Zhang X, Narayanan UG. Measurement of health-related quality of life in children undergoing external fixator treatment for lower limb deformities. J Pediatr Orthop. 2009 Dec;29(8):920-6. doi: 10.1097/BPO.0b013e3181c1e2e2.
- Results publication: PubMed 19568011Hamdy RC, Montpetit K, Raney EM, Aiona MD, Fillman RR, MacKenzie W, McCarthy J, Chafetz RS, Thomas SS, Tamayo CM, Littleton AG, Ruck-Gibis J, Takahashi SN, Rinaldi M, Finley GA, Platt RW, Dahan-Oliel N. Botulinum toxin type A injection in alleviating postoperative pain and improving quality of life in lower extremity limb lengthening and deformity correction: a pilot study. J Pediatr Orthop. 2009 Jul-Aug;29(5):427-34. doi: 10.1097/BPO.0b013e3181aad628.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reggie Hamdy, MD principal investigator
Shriners Hospital for Children-Canadian Unit, Montreal, Quebec
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Botulinum toxin A injection and saline injection in people with Unequal Length of Limbs; Congenital and Lower Extremity Deformities, Congenital, run by Shriners Hospitals for Children at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
average pain scores in 1st 4 days post op (time frame: 1st 4 days post op). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00412035, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2014.