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Bracing

Thoracolumosacral Orthosis for Back brace

Phase 4
Waitlist Available
Research Sponsored by Hospital for Special Surgery, New York
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 30-75-years-old
* Undergoing primary thoracolumbosacral fusion for ASD with an upper instrumented vertebrae (UIV) between T8-L2 and lower instrumented vertebrae (LIV) of S1 or the ilium.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 week and 6-month time points
Awards & highlights

Summary

Proximal junctional kyphosis (PJK) is a common post-operative radiographic finding after surgery for adult spinal deformity (ASD) patients. Although the clinical relevance of isolated PJK is unclear, PJK can progress to symptomatic proximal junctional failures which requires a large revision surgery. Currently, post-operative bracing with a thoracolumbosacral orthosis (TLSO) is common practice after spinal deformity surgery, however the efficacy of this in preventing PJK is unknown. This multi-center randomized control trial identified 84 patients undergoing thoracolumbosacral fusion for ASD and plans to study the efficacy of a novel post-operative TLSO in preventing the development of PJK as defined by the proximal junctional angle on 6-month post-operative X-rays.

Who is the study for?
This trial is for patients who have had surgery to correct adult spinal deformity and are at risk of developing a condition called Proximal Junctional Kyphosis (PJK). Participants must be suitable for post-operative bracing.
What is being tested?
The study tests the effectiveness of a new back brace, Align PJK™ TLSO, in preventing PJK when compared with standard care. It's a multi-center randomized control trial where participants' spine angles will be measured after 6 months.
What are the potential side effects?
While specific side effects are not listed, wearing any TLSO brace can cause discomfort, skin irritation or pressure sores due to prolonged contact and restricted movement.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 week and 6-month time points
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 week and 6-month time points for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The incidence of proximal junctional kyphosis development
Secondary study objectives
Change in patient reported outcome measures

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Thoracolumosacral OrthosisExperimental Treatment1 Intervention
Patients randomized to this arm will be fitted with an Aspen Medical Products "Align PJK™" TLSO brace. This is a 3-point, rigid hyperextension TLSO brace which is currently FDA approved under a 510k exemption but not commercially available. With this brace, the sternal pad height/width and belt component will be adjusted to optimize patient position and comfort. The brace will also be fitted with an external temperature sensing probe. Patients will be instructed to wear the brace at all times, including when in bed for 6-weeks post-operatively. At the 6-week visit patients will be asked to self-report compliance with the brace
Group II: No bracePlacebo Group1 Intervention
Patients in the control arm will be treated without a brace but will have no other differences in their post-operative treatment protocol. This will be considered "usual care" for the purposes of this study.

Find a Location

Who is running the clinical trial?

Aspen Medical ProductsOTHER
6 Previous Clinical Trials
243 Total Patients Enrolled
Hospital for Special Surgery, New YorkLead Sponsor
248 Previous Clinical Trials
59,644 Total Patients Enrolled
~56 spots leftby Dec 2025
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