Physical Activity Monitoring for Scoliosis

(SAMUS SCOLI Trial)

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Muscle conditions, Neuromuscular scoliosis

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 year

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand the link between physical activity, muscle behavior, and scoliosis, a condition where the spine curves abnormally. It examines how these factors might influence the causes of scoliosis and ways to lessen the impact of treatments like spinal fusion surgery. The trial includes different groups: those needing spinal fusion surgery, those using a spinal brace, and a control group of children without scoliosis. Children aged 9 to 16 with severe scoliosis needing surgery or bracing, or those without scoliosis but with healed forearm fractures, may be eligible to join. As an unphased trial, this study offers a unique opportunity to contribute to understanding scoliosis and improving future treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that spinal fusion surgery for scoliosis is generally safe and well-tolerated. One study reported no deaths or major nerve issues among patients who underwent this surgery. Only a small number of patients (2.2%) experienced pseudarthrosis, a complication related to bone healing. Another study found that advanced surgical techniques can enhance safety for teenagers with scoliosis. Overall, these findings suggest that spinal fusion surgery is a safe option for treating severe scoliosis curves. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the impact of physical activity monitoring in scoliosis patients who are undergoing bracing or spinal fusion surgery. Unlike the current standard of care, which typically focuses on correcting spinal curvature through surgery or bracing, this trial investigates how tracking physical activity and muscle stiffness using advanced technologies like Tri-axial accelerometers and Shear Wave Elastography ultrasound could provide new insights into patient outcomes. By understanding these factors, researchers hope to refine treatment protocols and improve long-term results for individuals with scoliosis.

What evidence suggests that this trial's treatments could be effective for scoliosis?

Research has shown that spinal fusion surgery, one of the treatments studied in this trial, effectively treats scoliosis. Studies have found that it can straighten the main curve in the upper back, with 57% of patients also experiencing improvement in the lower back curve. This surgery is known for providing long-lasting results and better movement in the trunk area. Additionally, a specific type of fusion surgery in the lower back can improve the correction of the spine's shape and enhance overall function. While the surgery is effective, complications such as wear and tear of the spinal discs can occur afterward. ^{6 7 8 9 10}

Who Is on the Research Team?

Todd Milbrandt, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for boys and girls aged 9-16 with severe scoliosis needing spinal fusion surgery or brace treatment. A control group of similar age, gender, and BMI with healed forearm fractures will also participate to compare muscle function.

Inclusion Criteria

I am a child with a healed forearm fracture, matched in age, gender, and BMI with the case patients.

I am between 9 and 16 years old.

I need surgery for my severe scoliosis.

Exclusion Criteria

Patients with underlying muscle conditions or neuromuscular scoliosis

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Physical activity and paraspinal muscle stiffness are measured using Tri-axial accelerometers and Shear Wave Elastography before treatment

4 days

1 visit (in-person)

Treatment

Participants undergo bracing or spinal fusion surgery for scoliosis treatment

1 year

Follow-up Assessment

Physical activity and paraspinal muscle stiffness are re-evaluated using Tri-axial accelerometers and Shear Wave Elastography one year after treatment

4 days

1 visit (in-person)

Follow-up

Participants are monitored for changes in physical activity and muscle function after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bracing
• Shear Wave Elastography (SWUE)
• Spinal Fusion Surgery
• Tri-axial Accelerometers

Trial Overview The study examines how treatments like spinal fusion surgery and bracing affect muscle activity in young scoliosis patients using devices that measure movement (Tri-axial Accelerometers) and muscle stiffness (Shear Wave Elastography).

How Is the Trial Designed?

Group I: Control Arm Experimental Treatment 2 Interventions

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.

Group II: Brace Treatment Active Control 3 Interventions

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.

Group III: Spinal Fusion Surgery Active Control 3 Interventions

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.

Spinal Fusion Surgery is already approved in United States, European Union for the following indications:

Approved in United States as Tymlos for:

• Osteoporosis in postmenopausal women at high risk of fracture
• Increase bone density in men with osteoporosis

Approved in European Union as Eladynos for:

• Osteoporosis in postmenopausal women at increased risk of fracture

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S259013972500081X

Assessment of range of motion and muscle strength after ... 4. Discussion. Spinal fusion surgery has long been known to provide optimal long-term results and improve trunk mobility in scoliosis patients.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3836950/

Outcomes in Adult Scoliosis Patients Who Undergo Spinal ... Outcomes: The outcomes include rate of revision surgery, loss of deformity correction (lumbar lordosis, sagittal balance), and poor functional outcome scores.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11536752/

Long-term outcomes of spinal fusion in adolescent ... Furthermore, correction of the main thoracic curve led to a spontaneous lumbar curve correction in 57% of patients [36]. In summary, based on ...

4. scoliosisjournal.biomedcentral.com scoliosisjournal.biomedcentral.com/articles/10.1186/s13013-018-0157-z

Long-term outcome of posterior spinal fusion for the correction ... In spite of the efficacy and safety of PSF surgery of AIS, it might result in irreversible complications such as DDD.

5. jss.amegroups.org jss.amegroups.org/article/view/7279/html

Comparative effectiveness of lumbar interbody fusion ... Conclusions: LLIF demonstrates efficacy in adult scoliosis management, with favorable outcomes in terms of deformity correction and functional improvement. The ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/15371702/

Safety and Efficacy of Isola Instrumentation and Arthrodesis ... Results: There were no deaths, spinal cord or nerve root problems, or acute posterior wound infections. Proven pseudarthrosis occurred in 4 patients (2.2%) and ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/20192668/

Early outcomes and safety of the minimally invasive, lateral ... Results: The authors identified 25 patients with adult degenerative deformity who were treated using the minimally invasive, lateral retroperitoneal transpsoas ...

8. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-025-05466-z

Efficacy and safety of long fusion versus short fusion in ... This study aimed to evaluate the efficacy and safety of long fusion versus short fusion in patients with degenerative scoliosis.

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2212134X18302661

Quality, Safety, and Value of Innovating Classic Operative ... Use of intraoperative navigation for posterior spinal fusion in adolescent idiopathic scoliosis surgery is safe to consider. 2021, Spine Deformity. The ...

10. ijssurgery.com ijssurgery.com/content/12/4/441

A 2-Year Follow-Up Pilot Study Background: This trial reports the 2-year and immediate postremoval clinical outcomes of a novel posterior apical short-segment (PASS) ...