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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Align PJK™ TLSO brace to determine if it can prevent proximal junctional kyphosis (PJK), a condition that sometimes occurs after spine surgery for adult spinal deformity. PJK can lead to complications requiring additional surgery, so researchers aim to see if wearing this brace post-surgery makes a difference. Some participants will wear the brace, while others will not, to compare outcomes. Eligible participants have undergone a specific type of spine surgery for adult spinal deformity. As a Phase 4 trial, this research focuses on understanding how the already FDA-approved and effective treatment can benefit more patients.

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.

What is the safety track record for the Align PJK™ TLSO brace?

Studies have shown that the Align PJK™ TLSO brace has received FDA approval, indicating its safety due to its similarity to other approved devices. This suggests that patients generally tolerate the brace well. Designed to support the spine and limit movement after surgery, it can help reduce complications like proximal junctional kyphosis (PJK).

No specific reports of problems caused by the brace have emerged. However, as with any device affecting movement, some discomfort may occur while adjusting to it. The brace can be adjusted for comfort to better fit each person and enhance their experience. Overall, the safety of the Align PJK™ brace appears promising based on its FDA approval and design. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for Proximal Junctional Kyphosis, which often involve surgery and post-operative observation, the Align PJK™ TLSO brace is unique because it's a specialized, rigid hyperextension brace designed to optimize the patient's posture and comfort. Researchers are excited about this brace due to its innovative design, which includes an adjustable sternal pad and an external temperature sensing probe, offering a new level of customization and monitoring not available in current options. Moreover, its FDA approval under a 510k exemption suggests it might provide effective support and recovery without the need for more invasive procedures.

What evidence suggests that the Align PJK™ TLSO brace is effective for preventing proximal junctional kyphosis?

Research shows that back braces like the Align PJK™ aim to reduce the risk of proximal junctional kyphosis (PJK) after surgery for adult spine issues. However, studies have shown mixed results. Some research suggests that wearing a brace after surgery does not significantly lower the chances of developing PJK in adults who undergo spinal fusion surgery. In this trial, participants in one arm will wear the Align PJK™ brace, designed to provide extra support and limit spine movement, potentially preventing PJK. Although the FDA has approved this brace, its effectiveness in reducing PJK after surgery remains under study. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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.

Body mass index (BMI) >35 kg/m2

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

Citations

1. aspenmp.com aspenmp.com/products/align-orthosis

Align Orthosis - TLSO

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11571403/

A Propensity Matched Analysis of Braced versus Non- ... Determine effects of bracing on proximal junctional kyphosis (PJK) after adult deformity correction. Methods. Patients were identified from a single-surgeon ...

3. spsco.com spsco.com/media/download/techsupport/aspen/sell%20sheet%20LIT5251A_PJK_Sell_Sheet_07-17-24_Final.pdf

Align PJK Orthosis Developed to reduce the occurrence of Proximal. Junctional Kyphosis (PJK) in post-operative patients, this prefabricated TLSO provides enhanced flexion.

4. ctv.veeva.com ctv.veeva.com/study/post-operative-thoracolumosacral-orthosis-for-pjk

Post-Operative Thoracolumosacral Orthosis for PJK This multi-center randomized control trial identified 84 patients undergoing thoracolumbosacral fusion for ASD and plans to study the efficacy ...

5. researchgate.net researchgate.net/publication/344793912_P86_Postoperative_bracing_does_not_improve_the_rate_of_proximal_junctional_kyphosis_in_adult_spinal_deformity

P86. Postoperative bracing does not improve the rate of ... We sought to determine whether postoperative bracing results in decreased rates of PJK in ASD treated with open posterior instrumented fusion (PSF) greater ...

6. pelsupply.com pelsupply.com/search/~@:D30100/product/true

PEL :: Search The Align PJK brings a new standard of care to spinal deformity post-op procedures with proven clinical efficacy in reducing risk and creating an optimal ...

7. alignpjk.aspenmp.com alignpjk.aspenmp.com/

Align PJK The Align PJK Orthosis is a prefabricated TLSO that provides optimal flexion control and circumferential stabilization to reduce readmittance rates.