Foot Deformities Clinical Trial
Official title:
Botulinum Toxin: an Adjunct in Limb Reconstruction - Can it Reduce Pain and Joint Complications in the Lengthening Phase?
The surgery to correct leg & foot deformities in children is a lengthy, & sometimes,
difficult procedure. Metal frames are attached to the leg and / or foot and over a period of
time the frame is manipulated to obtain the corrected position. During this period the
muscles & skin become very tight which causes pain & may pull the joint out of position.
When this happens it is sometimes necessary to stop the treatment before the best position
is obtained. This means that not only is the child left with an inadequate result but that
further surgery is required in the future.
If the tension could be removed whilst the treatment is underway this would reduce the pain,
the possibility of joint damage & potentially allow a more satisfactory to be obtained
without the need for further surgery.
Botulinum toxin or Botox, as it is commonly called, has the potential to temporarily reduce
the tension in the muscles without causing permanent damage.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | May 2010 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Years to 16 Years |
Eligibility |
Inclusion Criteria: - Any child with femoral, tibial deformity or CTEV having limb reconstruction surgery which involves the distraction of bone and or soft tissue. Exclusion Criteria: - Children with neurological aetiology |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Clinical Research Facility, Sheffield Children's Hospital | Sheffield | South Yorkshire |
Lead Sponsor | Collaborator |
---|---|
Sheffield Children's NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The pain levels using a visual analogue scale validated at the Sheffield Children's Hospital | 2 years | No | |
Secondary | Range of movement in affected joints measured by a goniometre | 2 years | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05555459 -
Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation
|
N/A | |
Completed |
NCT05579054 -
Translation, Validity, and Reliability of the Foot Posture Index (FPI-6) - Turkish Version
|
||
Completed |
NCT04054804 -
Digital Foot Check by Using the D-Foot, a New Software
|
||
Enrolling by invitation |
NCT05043636 -
Diabetic Neuropathy Screening Study 1.1 + Substudy 1.2-1.3-1.4
|
||
Completed |
NCT04468555 -
Hallux Valgus Manual Therapy Based on Global Postural Reeducation.
|
N/A | |
Completed |
NCT05519436 -
Investigation of the Relationship Between Plantar Foot Pressure and Balance in Morbidly Obese Individuals
|
||
Completed |
NCT05887765 -
Effect of Systematic Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Pediatric Ankle Surgery
|
Phase 4 | |
Completed |
NCT05558449 -
Impact of Virtual Reality Hypno-sedation on Functional Recovery and Anxiety in Foot Surgery With Regional Anesthesia
|
Phase 4 | |
Completed |
NCT03954301 -
Using the Hierarchical Cluster Method for Foot Deformities
|
||
Completed |
NCT04327622 -
Prevalence and Risk Evaluation of Diabetic Complications of the Foot in A Large Canadian Population
|
||
Withdrawn |
NCT06258499 -
Bone Healing Accelerant (BHA) Versus Autologous Bone Grafting (ABG) for Hindfoot or Ankle Arthrodesis
|
Phase 2 | |
Not yet recruiting |
NCT04627935 -
The Effect of Foot Deformities on Physical Activity, Fatigue Level and Quality of Life in Elderly COPD Patients
|
||
Completed |
NCT04312828 -
Assessment of Orthopedic Care of the Z-shaped Foot in Infant
|
||
Completed |
NCT04054076 -
10 Years Follow-up Study of Plantar Pressure, Kinetics and Kinematics in a Cohort of Patients Diagnosed With Diabetes
|
N/A | |
Completed |
NCT05656014 -
The Relationship of the Medial Longitudinal Arch Height With Clinical Features of Knee Osteoarthritis
|
||
Not yet recruiting |
NCT05408156 -
Effects of Customized Insoles for Individuals With Symptomatic Hallux Valgus
|
N/A | |
Not yet recruiting |
NCT06319937 -
Muscle Architecture in Knee Osteoarthritis
|
N/A | |
Completed |
NCT05437042 -
Effect of Medial Wedge on Static Balance in Pronated Feet
|