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Bracing

Back Brace for Proximal Junctional Kyphosis

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.

Must not have

Osteoporosis (defined as a T-score <-2.5 at the time of surgery)

Revision fusions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 week and 6-month time points

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial will study whether a new type of brace can help prevent a common complication called proximal junctional kyphosis after spinal surgery. The complication can lead to more severe issues and require additional surgery

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

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I am between 30 and 75 years old.

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I am having spine surgery for ASD with specific vertebrae involved.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with osteoporosis.

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I have had a revision fusion surgery.

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I have a type of inflammatory joint disease.

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My deformity is due to a condition like Parkinson's, cerebral palsy, or a stroke.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 week and 6-month time points

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

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

0 / 6Eligibility criteria met