Lower Limbs DeformitiesLLDNCT01255241
The Effect of Lower Limb Deformities (LLD) on Children's Gait and on Energy Expenditure
An observational study of Lower Limbs Deformities and Gait, run by Rambam Health Care Campus at 2 sites in Israel.
Trial summary
Lower Limb Deformities (LLDF) is a rather common infirmity among children. LLDF may result from various conditions such as trauma, tumors, infection, and dysplasia, congenital and metabolic abnormalities. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Lower Limbs Deformities, Gait, Energy Expenditure
- How many people
- 30 participants
- Where
- 2 sitesIsrael
- Study dates
- Feb 2011to Aug 2014
- Phase
- Observational
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Thirty patients will be recuited from primary care clinic
Who may be able to join
- Male and female young patients, age ranging between six to eighteen years.
- Presenting
- Lower limb mechanical axis deviation of 1.5 centimeters or more
- Deviation of 5 degree or more from the normal values in the joint orientation angles
Who cannot join
- Patients presenting neurological and neuromuscular disorders, scoliosis, kyphosis, mental retardation, Lower Limb Deformity (LLD) more than 2 cm measured at x-ray.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Recruiting
Rambam Medical Center
Haifa, Israel, 31096
Michael Zaidman, MD Phd, 972 50 2016 4563, orthmz@gmail.com
Michael Zaidman, MDPhD
- Recruiting
Michael Zaidman
Haifa, 31096
Michael Zaidman, MD, PhD, 972502064563, orthmz@gmail.com
About this study
Lower Limb Deformities (LLDF) is a rather common infirmity among children. LLDF may result from various conditions such as trauma, tumors, infection, and dysplasia, congenital and metabolic abnormalities. It is assumed that correction of deformities by surgical procedure will improve ambulation and reduce energy expenditure.
This prospective study will document the process of establishing the initial localization and magnitude of deformity through physical and radiological examination, kinetic and kinematical parameters, and measuring energy expenditure. The study will also document the type of surgical intervention undertaken to correct the deformity. Following a recovery from surgery, children's ambulation will be assessed again, by physical and radiological examination, by kinetic and kinematical parameters, and by measuring energy expenditure. A third series of exams will be performed four months later.
It is expected that the surgical intervention will improve ambulation and reduce energy expenditure. This study aims at establishing a model enabling to assess ambulation and energy expenditure before and after surgical intervention. The results of the study may have practical implications on the decision and type of surgical procedures.
Read the detailed description
Thirty patients, age ranging between six to eighteen years will be studied by kinetic and kinematic parameter to assess the initial status ambulation. Energy expenditure will be measured by metabolic monitoring. Patients will undergo the needed surgical intervention and their ambulation will be re-assessed by the same parameters upon recovery, and four months later on. All patients /or their parents will sign and informed consent form.
Patients with LLDF will be subdivided according to the anatomic localization of deformity (proximal femur, distal femur, femoral shaft, proximal tibia, distal tibia, tibial shaft, combined complex deformity) and the deformity plane (frontal, sagittal, axial, and oblique). The patients will undergo a complete physical routine examination. The deformity plane, localization and magnitude will be defined by radiological measurements and by physical examination. Rotational profile will be determined by physical examination.
Patients meeting the inclusion criteria will undergo a first gait analysis. Patients will walk on a flat floor, to establish locomotion base line, assess joint range of motions (ROM) during ambulation (kinematics), and recording of moments and powers of the joints (kinetics).
While walking on the flat floor, a first measurement of energy expenditure will be made. Subsequently children will walk on a treadmill while they are connected to the metabolic monitor.
Patients will undergo the required type of surgical correction of the deformity.
Following recovery , including regaining of range of motion (ROM), and antalgic gait, patients will undergo the second gait analysis and Energy expenditure measurements, which will be schedule two to four months after the surgery and according to the type od surgical intervention. The third gait lab and energy expenditure exams will be performed four month afterwards. The results will be analyzed and compared to those obtained prior to the intervention. The overall time for the study is planned for 24 months. Results will be analyzed by ANOVA and post hoc tests.
- Conditions
- Lower Limbs Deformities, Gait, Energy Expenditure
- Keywords
- Lower Limbs Deformities, kinetics, kinematics, gait, energy expenditure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| othopaedic surgical intervention | children with lower limbs deformities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower limbs deformities defined as (a) lower limb mechanical axis deviation of 1.5 centimeters or more(b) Deviation of 5 degree or more from the normal values in the joint orientation angles
Initial status ambulation and Energy expenditure will be assessed upon enrolment, two to four months after surgery, and four months later.
Measured: within four to six months after surgery and up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2010 (estimated)
- Study startFeb 2011
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lower Limbs DeformitiesStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Investigators
- Michael Zaidman, MPhD, Principal investigator, Rambam Health Care CampusMichael Zaidman, MD, PhD, Principal investigator, Rambam Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01255241
- Sponsor's protocol ID
- 0518-10CTIL
- Acronym
- LLD
- Status last verified
- Jul 2011
- First submitted
- 6 Dec 2010
- Last updated
- 29 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Carmeli E, Beiker R, Maor M, Kodesh E. Increased iNOS, MMP-2, and HSP-72 in skeletal muscle following high-intensity exercise training. J Basic Clin Physiol Pharmacol. 2010;21(2):127-46. Horowitz M, Kodesh E. Molecular Signals That Shape the Integrative Responses of the Heat Acclimated Phenotype.Med Sci Sports Exerc. 2010 Apr 16. Carmeli E, Maor M, Kodesh E. Expression of superoxide dismutase and matrix metalloproteinase type 2 in diaphragm muscles of young rats.J Physiol Pharmacol. 2009 Nov;60 Suppl 5:31-6. Kodesh E, Horowitz M.Soleus adaptation to combined exercise and heat acclimation: physiogenomic aspects.Med Sci Sports Exerc. 2010 May;42(5):943-52. Carmeli E, Kodesh E, Nemcovsky C. Tetracycline therapy for muscle atrophy due to immobilization. J Musculoskelet Neuronal Interact. 2009 Apr- Jun;9(2):81-8. Bodell PW, Kodesh E,Haddad F, Zaldivar FP, Cooper DM, Adams GR. Skeletal muscle growth in young rats is inhibited by chronic exposure to IL-6 but preserved by concurrent voluntary endurance exercise.J Appl Physiol. 2009 Feb;106(2):443-53 Horowitz M, Eli-Berchoer L,Wapinski I, Friedman N, Kodesh E.Stress-related genomic responses during the course of heat acclimation and its association with ischemic-reperfusion cross-tolerance.J Appl Physiol. 2004 Oct;97(4):1496-507. Wolach B, Falk B, Gavrieli R, Kodesh E, Eliakim A. Br J Sports. Neutrophil function response to aerobic and anaerobic exercise in female judoka and untrained subjects. Med. 2000 Feb;34(1):23-8. Wolach B, Eliakim A, Gavrieli R, Kodesh E, Yarom Y, Schlesinger M, Falk B. Aspects of leukocyte function and the complement system following aerobic exercisein young female gymnasts. Scand J Med Sci Sports. 1998 Apr;8(2):91-7. Eliakim A, Wolach B, Kodesh E, Gavrieli R, Radnay J, Ben-Tovim T, Yarom Y, Falk B.Cellular and humoral immune response to exercise among gymnasts and untrained girls. Int J Sports Med. 1997 Apr;18(3):208-12.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lower Limb Deformities (LLD) on Children's Gait and on Energy Expenditure
- ClinicalTrials.gov ID
- NCT01255241
- Acronym / sponsor ID
- LLD / 0518-10CTIL
- Conditions
- Lower Limbs Deformities, Gait, Energy Expenditure
- Keywords
- Lower Limbs Deformities, kinetics, kinematics, gait, energy expenditure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Feb 2011
- Study completion
- Aug 2014 (estimated)
- First posted
- 7 Dec 2010 (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.
Lower Limb Deformities (LLDF) is a rather common infirmity among children. LLDF may result from various conditions such as trauma, tumors, infection, and dysplasia, congenital and metabolic abnormalities. It is assumed that correction of deformities by surgical procedure will improve ambulation and reduce energy expenditure.
This prospective study will document the process of establishing the initial localization and magnitude of deformity through physical and radiological examination, kinetic and kinematical parameters, and measuring energy expenditure. The study will also document the type of surgical intervention undertaken to correct the deformity. Following a recovery from surgery, children's ambulation will be assessed again, by physical and radiological examination, by kinetic and kinematical parameters, and by measuring energy expenditure. A third series of exams will be performed four months later.
It is expected that the surgical intervention will improve ambulation and reduce energy expenditure. This study aims at establishing a model enabling to assess ambulation and energy expenditure before and after surgical intervention. The results of the study may have practical implications on the decision and type of surgical procedures.
Detailed description
Thirty patients, age ranging between six to eighteen years will be studied by kinetic and kinematic parameter to assess the initial status ambulation. Energy expenditure will be measured by metabolic monitoring. Patients will undergo the needed surgical intervention and their ambulation will be re-assessed by the same parameters upon recovery, and four months later on. All patients /or their parents will sign and informed consent form.
Patients with LLDF will be subdivided according to the anatomic localization of deformity (proximal femur, distal femur, femoral shaft, proximal tibia, distal tibia, tibial shaft, combined complex deformity) and the deformity plane (frontal, sagittal, axial, and oblique). The patients will undergo a complete physical routine examination. The deformity plane, localization and magnitude will be defined by radiological measurements and by physical examination. Rotational profile will be determined by physical examination.
Patients meeting the inclusion criteria will undergo a first gait analysis. Patients will walk on a flat floor, to establish locomotion base line, assess joint range of motions (ROM) during ambulation (kinematics), and recording of moments and powers of the joints (kinetics).
While walking on the flat floor, a first measurement of energy expenditure will be made. Subsequently children will walk on a treadmill while they are connected to the metabolic monitor.
Patients will undergo the required type of surgical correction of the deformity.
Following recovery , including regaining of range of motion (ROM), and antalgic gait, patients will undergo the second gait analysis and Energy expenditure measurements, which will be schedule two to four months after the surgery and according to the type od surgical intervention. The third gait lab and energy expenditure exams will be performed four month afterwards. The results will be analyzed and compared to those obtained prior to the intervention. The overall time for the study is planned for 24 months. Results will be analyzed by ANOVA and post hoc tests.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| othopaedic surgical intervention | – | –children with lower limbs deformities |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Thirty patients will be recuited from primary care clinic
Key inclusion criteria (4 listed)
- Male and female young patients, age ranging between six to eighteen years.
- Presenting
Key exclusion criteria (1 listed)
- Patients presenting neurological and neuromuscular disorders, scoliosis, kyphosis, mental retardation, Lower Limb Deformity (LLD) more than 2 cm measured at x-ray.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lower limbs deformities defined as (a) lower limb mechanical axis deviation of 1.5 centimeters or more(b) Deviation of 5 degree or more from the normal values in the joint orientation angles
Time frame: within four to six months after surgery and up to one year
Initial status ambulation and Energy expenditure will be assessed upon enrolment, two to four months after surgery, and four months later.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2011.
- BackgroundCarmeli E, Beiker R, Maor M, Kodesh E. Increased iNOS, MMP-2, and HSP-72 in skeletal muscle following high-intensity exercise training. J Basic Clin Physiol Pharmacol. 2010;21(2):127-46. Horowitz M, Kodesh E. Molecular Signals That Shape the Integrative Responses of the Heat Acclimated Phenotype.Med Sci Sports Exerc. 2010 Apr 16. Carmeli E, Maor M, Kodesh E. Expression of superoxide dismutase and matrix metalloproteinase type 2 in diaphragm muscles of young rats.J Physiol Pharmacol. 2009 Nov;60 Suppl 5:31-6. Kodesh E, Horowitz M.Soleus adaptation to combined exercise and heat acclimation: physiogenomic aspects.Med Sci Sports Exerc. 2010 May;42(5):943-52. Carmeli E, Kodesh E, Nemcovsky C. Tetracycline therapy for muscle atrophy due to immobilization. J Musculoskelet Neuronal Interact. 2009 Apr- Jun;9(2):81-8. Bodell PW, Kodesh E,Haddad F, Zaldivar FP, Cooper DM, Adams GR. Skeletal muscle growth in young rats is inhibited by chronic exposure to IL-6 but preserved by concurrent voluntary endurance exercise.J Appl Physiol. 2009 Feb;106(2):443-53 Horowitz M, Eli-Berchoer L,Wapinski I, Friedman N, Kodesh E.Stress-related genomic responses during the course of heat acclimation and its association with ischemic-reperfusion cross-tolerance.J Appl Physiol. 2004 Oct;97(4):1496-507. Wolach B, Falk B, Gavrieli R, Kodesh E, Eliakim A. Br J Sports. Neutrophil function response to aerobic and anaerobic exercise in female judoka and untrained subjects. Med. 2000 Feb;34(1):23-8. Wolach B, Eliakim A, Gavrieli R, Kodesh E, Yarom Y, Schlesinger M, Falk B. Aspects of leukocyte function and the complement system following aerobic exercisein young female gymnasts. Scand J Med Sci Sports. 1998 Apr;8(2):91-7. Eliakim A, Wolach B, Kodesh E, Gavrieli R, Radnay J, Ben-Tovim T, Yarom Y, Falk B.Cellular and humoral immune response to exercise among gymnasts and untrained girls. Int J Sports Med. 1997 Apr;18(3):208-12.
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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.
Michael Zaidman, MPhD principal investigator
Rambam Health Care Campus
Michael Zaidman, MD, PhD principal investigator
Rambam Medical Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Limbs Deformities and Gait, run by Rambam Health Care Campus at 2 sites in Israel.
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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 29 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Zaidman, MD,PhD (972 50 206 4563, orthmz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower limbs deformities defined as (a) lower limb mechanical axis deviation of 1.5 centimeters or more(b) Deviation of 5 degree or more from the normal values in the joint orientation angles (time frame: within four to six months after surgery and up to one year). 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 NCT01255241, which also lists 1 linked publication.
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 29 Jul 2011.