Spinal CurvaturesNCT02761265
Gait and Balance in Thoracolumbar Spinal Deformity
A study testing Surgical intervention and None (Asymptomatic group) in people with Spinal Curvatures, run by Texas Back Institute at 1 site in United States.
Trial summary
Surgical intervention may provide pain relief and improvement in function but one area of significant clinical interest is the restoration/improvement in gait and functional balance. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Curvatures
- What is being tested?
- Surgical intervention and None (Asymptomatic group)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Dec 2018
- Phase
- Interventional
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 30 years and older
- Clinically diagnosed thoracolumbar and/or lumbo-sacro-pelvic deformity as defined by the SRS/Schwab classification systems as Cobb angle of 25° or greater
- Instrumentation to be used at 4 or more levels
- Able to ambulate without assistance and stand without assistance with participant eyes open for a minimum of 10 seconds
- Able and willing to attend and perform the activities described in the informed consent within the boundaries of the timelines set forth for pre-, and post-operative follow-up
Who cannot join
- History of prior attempt at fusion (successful or not) at the indicated levels, (history of one level fusion is not an exclusion)
- Major lower extremity surgery or previous injury that may affect gait (a successful total joint replacement is not an exclusion)
- BMI higher than 35
- Neurological disorder, diabetic neuropathy or other disease that impairs the patient's ability to ambulate or stand without assistance
- Usage of blood thinners
- Major trauma to the pelvis
- Pregnant or wishing to become pregnant during the study
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Texas Back Institute
Plano, Texas, 75093
Ram Haddas, PhD, 972-943-2730, rhaddas@texasback.com
About this study
Official title: The Effect of Thoracolumbar Spinal Deformity and Its Surgical Correction on Gait and Balance in Adults
Surgical intervention may provide pain relief and improvement in function but one area of significant clinical interest is the restoration/improvement in gait and functional balance. Based on the investigators knowledge, there is limited literature on biomechanics and neuromuscular control of the lower extremities and spine as assessed by objective gait analysis and balance strategies in adult degenerative scoliosis patients, pre and post surgical intervention. The purpose of this study is to determine the impact of spinal deformity on the biomechanics and neuromuscular control of the lower and upper extremities, and also investigate the impact of surgery on these functions as evaluated by gait and balance analyses using dynamic EMG, video motion capture and force plate analysis and also to compare these patients with healthy controls to better evaluate the extent of limitations before and after surgery.
Read the detailed description
Degenerative adult scoliosis results from age related changes leading to segmental instability, deformity and stenosis. Although the etiology is unclear, degenerative adult scoliosis is associated with progressive and asymmetric degeneration of the disc and facet joints, which typically lead to stenosis. By virtue of the narrowed spinal canal associated with the degeneration these patients frequently develop back pain, as well as leg pain, weakness, and numbness. With an aging population in the USA and an increased attention to quality of life versus cost issues in the current healthcare environment, degenerative adult scoliosis has become a considerable healthcare concern.
Patients with scoliosis demonstrate an altered gait pattern. Such differences include decreased step length and reduced range of motion in the upper and lower extremities, asymmetry of trunk rotation and ground reaction force in three-dimensions. Mahaudens et al. found a decrease in the muscular mechanical work associated with an increase of energy cost and a decrease in the muscular efficiency in a scoliosis population compared to healthy controls. Furthermore, scoliosis patients exert 30% more physical effort than healthy subjects to ensure habitual locomotion, and this additional effort requires a reciprocal increase of oxygen consumption. This altered gait pattern demonstrated by subjects with scoliosis may be due to changes in global postural control strategies caused by spinal deformity.
Previous research showed that scoliosis patients do not have impaired postural balance when compared to healthy controls, while several others did find an effect of scoliosis on postural balance. This discrepancy in findings may be due to differences in curve characteristics included and their effects on postural balance, curve types (single or double), number of different curve types, location of curves (thoracic and lumbar), and/or Cobb angles. Furthermore, Schimmel et al. found that postural balance one year after surgery did not improve as a result of the better spinal alignment, neither did the reduced range of trunk motion inherent to fusion negatively affect postural balance.
While medicinal interventions may assist with some of the associated co-morbid conditions, surgical interventions may be indicated for those patients with intractable and debilitating low back and leg pain. These surgeries have proven to be extremely successful in a majority of patients. The surgeries may involve decompression and instrumentation to stabilize the spine to achieve arthrodesis.
Surgical intervention may provide pain relief and improvement in function but one area of significant clinical interest is the restoration/improvement in gait and functional balance. Based on the investigators knowledge, there is limited literature on biomechanics and neuromuscular control of the lower extremities and spine as assessed by objective gait analysis and balance strategies in adult degenerative scoliosis patients, pre and post surgical intervention. The purpose of this study is to determine the impact of spinal deformity on the biomechanics and neuromuscular control of the lower and upper extremities, and also investigate the impact of surgery on these functions as evaluated by gait and balance analyses using dynamic Electromyograph (EMG), video motion capture and force plate analysis and also to compare these patients with healthy controls to better evaluate the extent of limitations before and after surgery.
- Conditions
- Spinal Curvatures
- Being tested
- Surgical intervention, None (Asymptomatic group)
- Keywords
- Degenerative Adult Scoliosis, Gait Analysis, Balance Analysis, Biomechanics, Neuromuscular Control, Thoracolumbar Deformity
- Medical subject headings
- Spinal Curvatures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical interventionProcedure or surgery
Surgery to correct spinal deformity
None (Asymptomatic group)Other
Gait and balance testing performed, no treatment in this asymptomatic group
| Study group | Role | What they receive |
|---|---|---|
| Surgical Group | Experimental | Gait and balance testing as well as self-reported outcome assessments to be administered before and after surgery Receives: Procedure: Surgical intervention |
| Control Group | Other | Gait and balance testing to be administered once in healthy subjects Receives: Other: None (Asymptomatic group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinematic Variables Change assessed with human motion capture system
3-Dimensional Range of Motion (ROM) during the stance and swing phase.
Measured: Prior to surgery; 3 and 12 months after surgery
Kinetic Variables Change assessed with human motion capture system
Vertical Ground Reaction Forces (GRF)
Measured: Prior to surgery; 3 and 12 months after surgery
Electromyography Variables Change assessed with an Electromyograph
Bilateral peak magnitude during the stance phase
Measured: Prior to surgery; 3 and 12 months after surgery
Spatio-Temporal Variables Change assessed with human motion capture system
Walking Speed
Measured: Prior to surgery; 3 and 12 months after surgery
Secondary outcomes (4)
Patient Self-Reported Outcome Assessments Change
Visual Analog Scale (VAS)
Measured: Prior to surgery; 3 and 12 months after surgery
Patient Self-Reported Outcome Assessments Change
Scoliosis Research Society (SRS) -22
Measured: Prior to surgery; 3 and 12 months after surgery
Patient Self-Reported Outcome Assessments Change
Neck Disability Index (NDI)
Measured: Prior to surgery; 3 and 12 months after surgery
Patient Self-Reported Outcome Assessments Change
Oswestry Disability Index (ODI)
Measured: Prior to surgery; 3 and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Spinal CurvaturesStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Back Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Alphatec Spine, Inc.
- Responsible party
- Principal investigator, Ram Haddas, Texas Back Institute
- Investigators
- Ram Haddas, PhD, Principal investigator, Texas Back Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02761265
- Sponsor's protocol ID
- TBIRF-SBL-003
- Status last verified
- May 2016
- First submitted
- 19 Apr 2016
- Last updated
- 4 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kotwal S, Pumberger M, Hughes A, Girardi F. Degenerative scoliosis: a review. HSS J. 2011 Oct;7(3):257-64. doi: 10.1007/s11420-011-9204-5. Epub 2011 Jun 11.
PubMed 23024623Kotwicki T, Chowanska J, Kinel E, Czaprowski D, Tomaszewski M, Janusz P. Optimal management of idiopathic scoliosis in adolescence. Adolesc Health Med Ther. 2013 Jul 23;4:59-73. doi: 10.2147/AHMT.S32088. eCollection 2013.
PubMed 24600296Ploumis A, Transfledt EE, Denis F. Degenerative lumbar scoliosis associated with spinal stenosis. Spine J. 2007 Jul-Aug;7(4):428-36. doi: 10.1016/j.spinee.2006.07.015. Epub 2007 Feb 28.
PubMed 17630141Engsberg JR, Bridwell KH, Reitenbach AK, Uhrich ML, Baldus C, Blanke K, Lenke LG. Preoperative gait comparisons between adults undergoing long spinal deformity fusion surgery (thoracic to L4, L5, or sacrum) and controls. Spine (Phila Pa 1976). 2001 Sep 15;26(18):2020-8. doi: 10.1097/00007632-200109150-00016.
PubMed 11547203Yang JH, Suh SW, Sung PS, Park WH. Asymmetrical gait in adolescents with idiopathic scoliosis. Eur Spine J. 2013 Nov;22(11):2407-13. doi: 10.1007/s00586-013-2845-y. Epub 2013 Jun 4.
PubMed 23732766Mahaudens P, Banse X, Mousny M, Detrembleur C. Gait in adolescent idiopathic scoliosis: kinematics and electromyographic analysis. Eur Spine J. 2009 Apr;18(4):512-21. doi: 10.1007/s00586-009-0899-7. Epub 2009 Feb 18.
PubMed 19224255Arima H, Yamato Y, Hasegawa T, et al. Gait analysis after corrective surgery for adult spinal deformity - good sagittal balance with improved lumber lordosis is important. Scoliosis. 2015;10(Suppl 1):O76.
Kramers-de Quervain IA, Muller R, Stacoff A, Grob D, Stussi E. Gait analysis in patients with idiopathic scoliosis. Eur Spine J. 2004 Aug;13(5):449-56. doi: 10.1007/s00586-003-0588-x. Epub 2004 Apr 3.
PubMed 15064994Schizas CG, Kramers-de Quervain IA, Stussi E, Grob D. Gait asymmetries in patients with idiopathic scoliosis using vertical forces measurement only. Eur Spine J. 1998;7(2):95-8. doi: 10.1007/s005860050037.
PubMed 9629931Chockalingam N, Dangerfield PH, Rahmatalla A, Ahmed el-N, Cochrane T. Assessment of ground reaction force during scoliotic gait. Eur Spine J. 2004 Dec;13(8):750-4. doi: 10.1007/s00586-004-0762-9. Epub 2004 Jun 22.
PubMed 15221574Giakas G, Baltzopoulos V, Dangerfield PH, Dorgan JC, Dalmira S. Comparison of gait patterns between healthy and scoliotic patients using time and frequency domain analysis of ground reaction forces. Spine (Phila Pa 1976). 1996 Oct 1;21(19):2235-42. doi: 10.1097/00007632-199610010-00011.
PubMed 8902968Mahaudens P, Detrembleur C, Mousny M, Banse X. Gait in adolescent idiopathic scoliosis: energy cost analysis. Eur Spine J. 2009 Aug;18(8):1160-8. doi: 10.1007/s00586-009-1002-0. Epub 2009 Apr 24.
PubMed 19390877O'Beirne J, Goldberg C, Dowling FE, Fogarty EE. Equilibrial dysfunction in scoliosis--cause or effect? J Spinal Disord. 1989 Sep;2(3):184-9.
PubMed 2520074Kuo FC, Wang NH, Hong CZ. Impact of visual and somatosensory deprivation on dynamic balance in adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2010 Nov 1;35(23):2084-90. doi: 10.1097/BRS.0b013e3181cc8108.
PubMed 20975488Karimi MT, Kavyani M, Kamali M. Balance and gait performance of scoliotic subjects: A review of the literature. J Back Musculoskelet Rehabil. 2016 Aug 10;29(3):403-15. doi: 10.3233/BMR-150641.
PubMed 26519115
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Thoracolumbar Spinal Deformity and Its Surgical Correction on Gait and Balance in Adults
- ClinicalTrials.gov ID
- NCT02761265
- Acronym / sponsor ID
- TBIRF-SBL-003
- Conditions
- Spinal Curvatures
- Keywords
- Degenerative Adult Scoliosis, Gait Analysis, Balance Analysis, Biomechanics, Neuromuscular Control, Thoracolumbar Deformity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Texas Back InstituteUniversity, hospital or other
- Collaborators
- Alphatec Spine, Inc.
- Study start
- Mar 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 4 May 2016 (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.
Surgical intervention may provide pain relief and improvement in function but one area of significant clinical interest is the restoration/improvement in gait and functional balance. Based on the investigators knowledge, there is limited literature on biomechanics and neuromuscular control of the lower extremities and spine as assessed by objective gait analysis and balance strategies in adult degenerative scoliosis patients, pre and post surgical intervention. The purpose of this study is to determine the impact of spinal deformity on the biomechanics and neuromuscular control of the lower and upper extremities, and also investigate the impact of surgery on these functions as evaluated by gait and balance analyses using dynamic EMG, video motion capture and force plate analysis and also to compare these patients with healthy controls to better evaluate the extent of limitations before and after surgery.
Detailed description
Degenerative adult scoliosis results from age related changes leading to segmental instability, deformity and stenosis. Although the etiology is unclear, degenerative adult scoliosis is associated with progressive and asymmetric degeneration of the disc and facet joints, which typically lead to stenosis. By virtue of the narrowed spinal canal associated with the degeneration these patients frequently develop back pain, as well as leg pain, weakness, and numbness. With an aging population in the USA and an increased attention to quality of life versus cost issues in the current healthcare environment, degenerative adult scoliosis has become a considerable healthcare concern.
Patients with scoliosis demonstrate an altered gait pattern. Such differences include decreased step length and reduced range of motion in the upper and lower extremities, asymmetry of trunk rotation and ground reaction force in three-dimensions. Mahaudens et al. found a decrease in the muscular mechanical work associated with an increase of energy cost and a decrease in the muscular efficiency in a scoliosis population compared to healthy controls. Furthermore, scoliosis patients exert 30% more physical effort than healthy subjects to ensure habitual locomotion, and this additional effort requires a reciprocal increase of oxygen consumption. This altered gait pattern demonstrated by subjects with scoliosis may be due to changes in global postural control strategies caused by spinal deformity.
Previous research showed that scoliosis patients do not have impaired postural balance when compared to healthy controls, while several others did find an effect of scoliosis on postural balance. This discrepancy in findings may be due to differences in curve characteristics included and their effects on postural balance, curve types (single or double), number of different curve types, location of curves (thoracic and lumbar), and/or Cobb angles. Furthermore, Schimmel et al. found that postural balance one year after surgery did not improve as a result of the better spinal alignment, neither did the reduced range of trunk motion inherent to fusion negatively affect postural balance.
While medicinal interventions may assist with some of the associated co-morbid conditions, surgical interventions may be indicated for those patients with intractable and debilitating low back and leg pain. These surgeries have proven to be extremely successful in a majority of patients. The surgeries may involve decompression and instrumentation to stabilize the spine to achieve arthrodesis.
Surgical intervention may provide pain relief and improvement in function but one area of significant clinical interest is the restoration/improvement in gait and functional balance. Based on the investigators knowledge, there is limited literature on biomechanics and neuromuscular control of the lower extremities and spine as assessed by objective gait analysis and balance strategies in adult degenerative scoliosis patients, pre and post surgical intervention. The purpose of this study is to determine the impact of spinal deformity on the biomechanics and neuromuscular control of the lower and upper extremities, and also investigate the impact of surgery on these functions as evaluated by gait and balance analyses using dynamic Electromyograph (EMG), video motion capture and force plate analysis and also to compare these patients with healthy controls to better evaluate the extent of limitations before and after surgery.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical Group | Experimental | Procedure: Surgical interventionGait and balance testing as well as self-reported outcome assessments to be administered before and after surgery |
| Control Group | Other | Other: None (Asymptomatic group)Gait and balance testing to be administered once in healthy subjects |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 30 years and older
- Clinically diagnosed thoracolumbar and/or lumbo-sacro-pelvic deformity as defined by the SRS/Schwab classification systems as Cobb angle of 25° or greater
- Instrumentation to be used at 4 or more levels
- Able to ambulate without assistance and stand without assistance with participant eyes open for a minimum of 10 seconds
- Able and willing to attend and perform the activities described in the informed consent within the boundaries of the timelines set forth for pre-, and post-operative follow-up
Key exclusion criteria (7 listed)
- History of prior attempt at fusion (successful or not) at the indicated levels, (history of one level fusion is not an exclusion)
- Major lower extremity surgery or previous injury that may affect gait (a successful total joint replacement is not an exclusion)
- BMI higher than 35
- Neurological disorder, diabetic neuropathy or other disease that impairs the patient's ability to ambulate or stand without assistance
- Usage of blood thinners
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 |
|---|---|---|
| Surgical interventionSurgery to correct spinal deformity | Procedure or surgery | Surgical Group |
| None (Asymptomatic group)Gait and balance testing performed, no treatment in this asymptomatic group | Other | Control Group |
Primary outcome
Kinematic Variables Change assessed with human motion capture system
Time frame: Prior to surgery; 3 and 12 months after surgery
3-Dimensional Range of Motion (ROM) during the stance and swing phase.
Kinetic Variables Change assessed with human motion capture system
Time frame: Prior to surgery; 3 and 12 months after surgery
Vertical Ground Reaction Forces (GRF)
Electromyography Variables Change assessed with an Electromyograph
Time frame: Prior to surgery; 3 and 12 months after surgery
Bilateral peak magnitude during the stance phase
Spatio-Temporal Variables Change assessed with human motion capture system
Time frame: Prior to surgery; 3 and 12 months after surgery
Walking Speed
4 secondary outcomes
Patient Self-Reported Outcome Assessments Change
Time frame: Prior to surgery; 3 and 12 months after surgery
Patient Self-Reported Outcome Assessments Change
Time frame: Prior to surgery; 3 and 12 months after surgery
Patient Self-Reported Outcome Assessments Change
Time frame: Prior to surgery; 3 and 12 months after surgery
Patient Self-Reported Outcome Assessments Change
Time frame: Prior to surgery; 3 and 12 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2016.
- Background: PubMed 23024623Kotwal S, Pumberger M, Hughes A, Girardi F. Degenerative scoliosis: a review. HSS J. 2011 Oct;7(3):257-64. doi: 10.1007/s11420-011-9204-5. Epub 2011 Jun 11.
- Background: PubMed 24600296Kotwicki T, Chowanska J, Kinel E, Czaprowski D, Tomaszewski M, Janusz P. Optimal management of idiopathic scoliosis in adolescence. Adolesc Health Med Ther. 2013 Jul 23;4:59-73. doi: 10.2147/AHMT.S32088. eCollection 2013.
- Background: PubMed 17630141Ploumis A, Transfledt EE, Denis F. Degenerative lumbar scoliosis associated with spinal stenosis. Spine J. 2007 Jul-Aug;7(4):428-36. doi: 10.1016/j.spinee.2006.07.015. Epub 2007 Feb 28.
- Background: PubMed 11547203Engsberg JR, Bridwell KH, Reitenbach AK, Uhrich ML, Baldus C, Blanke K, Lenke LG. Preoperative gait comparisons between adults undergoing long spinal deformity fusion surgery (thoracic to L4, L5, or sacrum) and controls. Spine (Phila Pa 1976). 2001 Sep 15;26(18):2020-8. doi: 10.1097/00007632-200109150-00016.
- Background: PubMed 23732766Yang JH, Suh SW, Sung PS, Park WH. Asymmetrical gait in adolescents with idiopathic scoliosis. Eur Spine J. 2013 Nov;22(11):2407-13. doi: 10.1007/s00586-013-2845-y. Epub 2013 Jun 4.
- Background: PubMed 19224255Mahaudens P, Banse X, Mousny M, Detrembleur C. Gait in adolescent idiopathic scoliosis: kinematics and electromyographic analysis. Eur Spine J. 2009 Apr;18(4):512-21. doi: 10.1007/s00586-009-0899-7. Epub 2009 Feb 18.
- BackgroundArima H, Yamato Y, Hasegawa T, et al. Gait analysis after corrective surgery for adult spinal deformity - good sagittal balance with improved lumber lordosis is important. Scoliosis. 2015;10(Suppl 1):O76.
- Background: PubMed 15064994Kramers-de Quervain IA, Muller R, Stacoff A, Grob D, Stussi E. Gait analysis in patients with idiopathic scoliosis. Eur Spine J. 2004 Aug;13(5):449-56. doi: 10.1007/s00586-003-0588-x. Epub 2004 Apr 3.
- Background: PubMed 9629931Schizas CG, Kramers-de Quervain IA, Stussi E, Grob D. Gait asymmetries in patients with idiopathic scoliosis using vertical forces measurement only. Eur Spine J. 1998;7(2):95-8. doi: 10.1007/s005860050037.
- Background: PubMed 15221574Chockalingam N, Dangerfield PH, Rahmatalla A, Ahmed el-N, Cochrane T. Assessment of ground reaction force during scoliotic gait. Eur Spine J. 2004 Dec;13(8):750-4. doi: 10.1007/s00586-004-0762-9. Epub 2004 Jun 22.
- Background: PubMed 8902968Giakas G, Baltzopoulos V, Dangerfield PH, Dorgan JC, Dalmira S. Comparison of gait patterns between healthy and scoliotic patients using time and frequency domain analysis of ground reaction forces. Spine (Phila Pa 1976). 1996 Oct 1;21(19):2235-42. doi: 10.1097/00007632-199610010-00011.
- Background: PubMed 19390877Mahaudens P, Detrembleur C, Mousny M, Banse X. Gait in adolescent idiopathic scoliosis: energy cost analysis. Eur Spine J. 2009 Aug;18(8):1160-8. doi: 10.1007/s00586-009-1002-0. Epub 2009 Apr 24.
- Individual participant dataSharing planned: No
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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.
Ram Haddas, PhD principal investigator
Texas Back Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical intervention and None (Asymptomatic group) in people with Spinal Curvatures, run by Texas Back Institute at 1 site in United States.
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 7 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 4 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 Ram Haddas, PhD (972-943-2730, rhaddas@texas.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinematic Variables Change assessed with human motion capture system (time frame: Prior to surgery; 3 and 12 months after surgery). The study lists 4 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 NCT02761265, which also lists 26 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 4 May 2016.