An interventional study of Spinal Fusion Surgery and Bracing in Scoliosis, sponsored by Mayo Clinic. Enrolling by invitation at 1 site in United States. Open to participants aged 9 Years to 16 Years. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment
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Among 153 studies in Scoliosis with a site in United States — 42 open to participants now, 52 under way, 2 of them phase 3. Scoliosis · United States.
Among the 153 studies in Scoliosis with a site in United States, this one is the 11th largest by planned enrollment of the 91 interventional ones that give a count, is one of 8 that started in 2015, is one of 65 with no phase, reaches primary completion later than 29 of the 51 other live ones, and was the 70th registered.
660 studies on the registry are indexed under Scoliosis; 186 are open to participants now.
Browse Scoliosis studies →42 of the 153 studies in Scoliosis with a site in United States are open now. Recruiting first, the newest first:
Children's Hospital Medical Center, Cincinnati · Sites in United States
Ages 14–26
Thinks Works, PBC · Sites in United States
Ages 9–16
Columbia University · Sites in United States
Ages 10–19
Senthil Sadhasivam · Sites in United States
Ages 10–18
Children's Hospital Los Angeles · Sites in United States
Ages 8–18
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 117 Scoliosis studies recruiting now, 23 (20%) set no upper age limit and 88 (75%) stop at 75 or younger; 98 take children under 18; 14 take healthy volunteers.
This study: 9 Years to 16 Years · all sexes · no healthy volunteers.
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153 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 6 · Phase 3 6 · Phase 4 15
First in 1998; this study’s year is marked. 8 started in 2015.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 200 is above the median of 45 across 386 interventional studies indexed under Scoliosis.
Median enrollment 58 across the 91 interventional studies, 100 across the 62 observational. Of the 84 that completed or were terminated, 35 (42%) have results posted.
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24 of 153 have an industry lead sponsor. The 10 most frequent:
Mayo Clinic is the lead sponsor of 3,271 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Mayo Clinic has 5 studies filed under Scoliosis — fewer than ten, so there is no comparison to draw.
20 of the studies in Scoliosis with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07217873Phase 3Columbia UniversityIntraVenous Iron in Kids With Iron Deficiency and Scoliosis Study | 2027-08-31 |
| NCT00738439International Spine Study Group FoundationProspective, Multi-Center Adult Spinal Deformity Outcomes Database Registry | 2026-12 |
| NCT06910228Joseph D. TobiasChanges in Cerebral Oxygenation Related to Intraoperative Position Changes | 2026-12 |
| NCT06365892University of California, San FranciscoOpen-label Placebo (COLP) for Pain in Adolescent Idiopathic Scoliosis (AIS) Surgery+Surgical Treatment of Idiopathic Scoliosis | 2026-12 |
| NCT03017755Mayo ClinicScoliosis Survey to Development Treatment Decision Tool | 2026-12-01 |
Add all 20 to your calendar (.ics) → With an account.
Among the 153 studies in Scoliosis with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study will explore the relationship between skeletal muscle and physical activity in scoliosis patients to provide insight into both the etiology of scoliosis and potential ways to mitigate the potential harms of treatment.
The aims include first, to quantify the posture and physical activity of patients in the community before and after scoliosis treatment and compare to age-matched controls. Patients undergoing bracing or surgery for scoliosis will wear novel low-profile electronic monitors for 4 days prior to and at one year after initiation of treatment. Accelerometer data from the 4 activity monitors are combined for a comprehensive profile of daily activity, above and beyond that of a typical pedometer. Analysis will show a participant's % active time vs. static, % time sitting vs. lying down vs. standing vs. walking, total number of steps taken per day, and cadence of walking during each activity bout. The amount of total daily time spent lying, sitting, standing, walking and running will be quantified using specialized processing algorithms developed at Mayo Clinic. Results will be compared to a group of age- and BMI-matched control patients with healed forearm fractures.
Second, to determine changes in the mechanical properties of the paraspinal skeletal musculature (muscles along the spine) in scoliosis patient before and after treatment with brace or spinal surgery.
Shear Wave Elastography (SWUE) is a technique that uses ultrasound, a non-invasive imaging technique, to detect mechanical properties of tissues. Using SWUE, the stiffness in the paraspinal muscles will be obtained by acquiring Shear modulus measurements, reported in kilo Pascal (kPa) units. 10 measurements will be obtained for each muscle and a region of interest (ROI) will be placed in the displayed elastogram or color map from each measurement to obtain a "kPa" value. A mean shear modulus or stiffness will be obtained by averaging all 10 results. The measurements from each ROI are derived using software built in the ultrasound equipment.
The change in paraspinal skeletal muscle stiffness will be assessed and compared to normal controls to determine characteristics of spinal musculature in scoliosis patients and the impact of treatment with bracing or surgery.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
- Patients with underlying muscle conditions or neuromuscular scoliosis
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The surgical participants recruited from the pediatric orthopaedic clinic and have severe scoliosis curves requiring posterior spinal fusion. Physical activity measured using Tri-axial accelerometers and paraspinal muscle stiffness measured by Shear Wave Elastography (SWUE) ultrasound will be quantified before and one year after spinal fusion surgery.
Procedure: Spinal Fusion Surgery · Device: Tri-axial Accelerometers · Other: Shear Wave Elastography (SWUE)
The bracing participants have scoliosis curves that require treatment with a spinal brace for at least the next year. All braces will have monitors to record hours of brace wear, as is current standard of care. Physical activity measured using Tri-axial accelerometers and paraspinal muscle stiffness measured by Shear Wave Elastography (SWUE) ultrasound will be quantified before bracing and after one year.
Other: Bracing · Device: Tri-axial Accelerometers · Other: Shear Wave Elastography (SWUE)
The control group are participants who do not have scoliosis. Physical activity measured using Tri-axial accelerometers and paraspinal muscle stiffness measured by Shear Wave Elastography (SWUE) ultrasound will be quantified at baseline and one year after enrollment.
Device: Tri-axial Accelerometers · Other: Shear Wave Elastography (SWUE)
Participants with severe scoliosis curves requiring spinal fusion surgery.
Participants with scoliosis curves that require brace treatment for at least the next year. Braces include monitors to record hours of brace wear, as is current standard of care.
Four monitors are place on the participant (waist, thigh, both ankles), attached with straps. Periods of static and dynamic activity are measured based on accelerations in three orthogonal directions for 4 day's time while participating in regular daily activities.
Also known as: ActiGraph GT3X+
SWUE is an ultrasound technique for noninvasively evaluating the mechanical properties (stiffness) of skeletal muscle tissue. A commercial ultrasound scanner (Aixplorer from Supersonic Imagine, France) with 2D real time SWUE will be used. The Aixplorer uses ultrasonic push beams to produce shear waves in tissue. The shear wave propagation speed is inherently related to tissue mechanical properties and is used to create a quantitative 2D elastogram of the tissue.
Change in percentage of day with static activity
Physical activity is measured by 4 wearable Tri-axial Accelerometers, worn for a 4 day period at baseline (prior to surgery or brace placement) and at one year after surgery of brace placement. Each second of data will be classified as static or dynamic. Among static postures, lying, standing and sitting are determined based on the orientation of the waist and thigh accelerometers in relation to the line of gravity. Accelerometer data from the 4 activity monitors are combined to provide a total percentage of time with static activities.
Time frame: Baseline, 1 year
Change in dynamic physical activity as measured by step counts
Physical activity is measured by 4 wearable Tri-axial Accelerometers worn for a 4 day period at baseline (prior to surgery or brace placement) and at one year after surgery of brace placement. Each second of data will be classified as static or dynamic. Dynamic movements will be classified as walking, jogging or stair climbing based activity that exceeds the pre-defined accelerometer amplitude threshold. Step counts will be calculated based on detection of peak accelerations of the bilateral ankles using adaptive thresholds during the longest period of walking. Accelerometer data from the 4 activity monitors are combined to provide a total measure of dynamic physical activity.
Time frame: Baseline, 1 year
Change in mean paraspinal muscle stiffness
Muscle stiffness is measured by Shear Wave Elastography (SWUE). This measurement evaluates normal muscle's passive and active properties at a variety of angles and tensions, resulting in a shear modulus reading, measured in average kilo Pascal units from 10 images of each muscle region of interest. A transducer is used with ultrasound to produce shear waves in tissue. The wave speed relates to the tissue's mechanical properties and is used to create a quantitative 2D elastogram of the tissue. Multiple shear modulus measurements will be averaged, and obtained: * on control subjects at the left and right sides of the T12 spine segment level * on the scoliosis patients, at the periapical area (apex of curve, where it is most tilted) * at the concave and convex sides as well as at an area remote from the curvature
Time frame: Baseline, 1 year
Plan to share: No
The record gives a start of Nov 2015, a primary completion of Aug 2027 and a completion of Aug 2027. It does not say whether these dates are actual or estimated.
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