Back Brace for Proximal Junctional Kyphosis

Recruiting at 6 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Hospital for Special Surgery, New York

Disqualifiers: Osteoporosis, High BMI, Neuromuscular, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

84 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How does the Align PJK™ TLSO brace treatment differ from other treatments for proximal junctional kyphosis?

The Align PJK™ TLSO brace is a unique treatment for proximal junctional kyphosis as it is a non-surgical option that provides external support to the spine, potentially reducing the risk of further spinal deformity after surgery. Unlike surgical interventions, this brace offers a less invasive approach to managing the condition. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

I am between 30 and 75 years old.

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

Exclusion Criteria

I have had a revision fusion surgery.

I have been diagnosed with osteoporosis.

Body mass index (BMI) >35 kg/m2

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Post-operative Treatment

Participants are fitted with a TLSO brace and instructed to wear it at all times for 6 weeks post-operatively

6 weeks

1 visit (in-person) at 6 weeks

Follow-up

Participants are monitored for the development of proximal junctional kyphosis and changes in patient-reported outcomes

6 months

2 visits (in-person) at 6 weeks and 6 months

Treatment Details

Interventions

• Align PJK™ TLSO brace

Trial Overview 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.

Participant Groups

Group I: Thoracolumosacral Orthosis Experimental Treatment 1 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 brace Placebo Group 1 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.

Who Is Running the Clinical Trial?

Hospital for Special Surgery, New York

Lead Sponsor

Trials

257

Recruited

61,800+

Aspen Medical Products

Collaborator

Trials

7

Recruited

330+

Findings from Research

In a study of 135 children with early-onset scoliosis (EOS) treated with distraction-based implants, 38% developed radiographic proximal junctional kyphosis (PJK), with preoperative thoracic kyphosis (TK) greater than 50 degrees identified as a significant risk factor.

Children with rib-based constructs had a lower incidence of PJK (31%) compared to those with spine-based constructs (54%), suggesting that the type of surgical construct may influence the risk of developing this complication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Spinopelvic Parameters on the Development of Proximal Junctional Kyphosis in Early Onset: Mean 4.5-Year Follow-up. Gomez, JA., Kubat, O., Tovar Castro, MA., et al.[2021]

The study assessed the measurement reliability of proximal junctional kyphosis (PJK) in 10 patients with growing rod instrumentation, revealing significant interobserver variability of over 20 degrees, which complicates consistent diagnosis.

Given that PJK is defined as a kyphosis greater than 10 degrees above the upper instrumented vertebrae, the high variability in measurements suggests that current methods may not be reliable enough for clinical use in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measurement Variability in the Evaluation of the Proximal Junction in Distraction-based Growing Rods Patients. Barrett, KK., Andras, LM., Tolo, VT., et al.[2018]

In a study of 14 patients with proximal junctional kyphosis (PJK) who underwent revision spine surgery, the most common causes were identified as overcorrection and osteopenia, each affecting 47% of the cases.

The study found a significant link between osteopenia and the occurrence of compression fractures leading to PJK, highlighting the need for a new classification system that considers both the causes and mechanisms of failure in PJK.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A single institution experience with proximal junctional kyphosis in the context of existing classification schemes - Systematic review. Elarjani, T., Basil, GW., Kader, MZ., et al.[2021]

In a study of 89 adults who underwent spinal fusion surgery, both proximal thoracic (PT) and distal thoracic (DT) upper instrumented vertebrae (UIV) showed similar rates of proximal junctional kyphosis (PJK) and revision surgeries, indicating that both approaches are effective in improving spinal alignment and patient quality of life.

However, the mechanisms of PJK differed between groups: compression fractures were more common in the DT group, while subluxation was more prevalent in the PT group, suggesting that different strategies may be needed to prevent these complications post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proximal junctional kyphosis and clinical outcomes in adult spinal deformity surgery with fusion from the thoracic spine to the sacrum: a comparison of proximal and distal upper instrumented vertebrae. Ha, Y., Maruo, K., Racine, L., et al.[2022]

In a study of 102 adult spinal deformity patients, the use of PMMA vertebroplasty did not significantly reduce the incidence of proximal junctional kyphosis (PJK), with rates of 55.4% in PMMA patients compared to 38.6% in controls.

The development of PJK was strongly associated with poor bone quality, highlighting the importance of preoperative screening and management of osteoporosis to improve surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polymethyl methacrylate augmentation and proximal junctional kyphosis in adult spinal deformity patients. Bartolozzi, AR., Oquendo, YA., Koltsov, JCB., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

The Effect of Spinopelvic Parameters on the Development of Proximal Junctional Kyphosis in Early Onset: Mean 4.5-Year Follow-up. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Measurement Variability in the Evaluation of the Proximal Junction in Distraction-based Growing Rods Patients. [2018]

3. Scotland pubmed.ncbi.nlm.nih.gov

A single institution experience with proximal junctional kyphosis in the context of existing classification schemes - Systematic review. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Proximal junctional kyphosis and clinical outcomes in adult spinal deformity surgery with fusion from the thoracic spine to the sacrum: a comparison of proximal and distal upper instrumented vertebrae. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Polymethyl methacrylate augmentation and proximal junctional kyphosis in adult spinal deformity patients. [2023]