Health TrialsbyHealthPanel

Post-Operative Thoracolumosacral Orthosis for PJK

ConditionsProximal Junctional KyphosisAdult Spinal Deformity SurgeryThoracolumbosacral Orthosis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age30-75
SponsorHospital for Special Surgery, New York

About 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 does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Body mass index (BMI) >35 kg/m2

Revision fusions

Fusions for trauma

Trial design

Design model

Parallel

Treatments tested in this trial

  • Align PJK™ TLSO brace

    Device

    Patients will get randomized to receiving and wearing a back brace for 6 weeks postoperatively.

  • Standard of Care

    Other intervention

    Patients will receive the standard of care postoperative instructions without a brace

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: Thoracolumosacral OrthosisExperimental treatment 1 intervention
Group B: No bracePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

The incidence of proximal junctional kyphosis development

As defined by a proximal junctional angle both ≥10° and 10°greater than pre-operative values.

Time frame
This will be measured via scoliosis radiographs at the pre discharge, 6-week, and 6-month time points.

Secondary outcomes

1

Change in patient reported outcome measures

VAS leg pain, and VAS back pain (scale of 0-10). 0= no pain; 10=worst possible pain

Time frame
6 week and 6-month time points
2

Change in patient reported outcome measures

Oswestry Disability Index (0-20% minimal disability; 21-40% moderate disability; 41-60% severe disability; 61-80 cripple, pain impinges on all aspects of life; 81-100% patients are bed bound)

Time frame
6 week and 6-month time points

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital for Special Surgery, New York

Lead sponsor

Aspen Medical Products

Collaborator

Source ClinicalTrials.gov
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