Proximal Junctional KyphosisPhase 4NCT06491030
Post-Operative Thoracolumosacral Orthosis for PJK
A Phase 4 study testing Align PJK™ TLSO brace in people with Proximal Junctional Kyphosis and Adult Spinal Deformity Surgery, run by Hospital for Special Surgery, New York at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Proximal Junctional Kyphosis, Adult Spinal Deformity Surgery, Thoracolumbosacral Orthosis
- What is being tested?
- Align PJK™ TLSO brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 6 sitesUnited States
- Study dates
- 2 Dec 2024to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
- Those with a neuromuscular etiology for their deformity (i.e. Parkinson's disease, cerebral palsy, post-stroke, etc.)
- An underlying inflammatory arthropathy
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 1 recruiting
- Active, not recruiting
University of Texas Health, Houston
Bellaire, Texas, 77401
- Active, not recruiting
Indiana Spine Group
Carmel, Indiana, 46032
- Active, not recruiting
Texas Back Institute
Dallas, Texas, 75243
- Recruiting
Hospital for Special Surgery
New York, New York, 10021
Rachel L Knopp, 2126061723, knoppr@hss.edu
Han Jo Kim, MD
- Active, not recruiting
University of Kansas
Overland Park, Kansas, 66211
- Active, not recruiting
Virgina Mason Franciscan Health
Seattle, Washington, 98101
About this study
Official title: The Use of a Novel Post-Operative Thoracolumosacral Orthosis for Prevention of Proximal Junctional Kyphosis After Adult Spinal Deformity Surgery
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.
- Being tested
- Align PJK™ TLSO brace, Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Align PJK™ TLSO braceDevice
Patients will get randomized to receiving and wearing a back brace for 6 weeks postoperatively.
Standard of CareOther
Patients will receive the standard of care postoperative instructions without a brace
| Study group | Role | What they receive |
|---|---|---|
| Thoracolumosacral Orthosis | Experimental | 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 Receives: Device: Align PJK™ TLSO brace |
| No brace | Placebo comparator | 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. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of proximal junctional kyphosis development
As defined by a proximal junctional angle both ≥10° and 10°greater than pre-operative values.
Measured: This will be measured via scoliosis radiographs at the pre discharge, 6-week, and 6-month time points.
Secondary outcomes (2)
Change in patient reported outcome measures
VAS leg pain, and VAS back pain (scale of 0-10). 0= no pain; 10=worst possible pain
Measured: 6 week and 6-month time points
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)
Measured: 6 week and 6-month time points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start2 Dec 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal Junctional KyphosisStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Collaborators
- Aspen Medical Products
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06491030
- Sponsor's protocol ID
- 2023-2446
- Status last verified
- Jan 2026
- First submitted
- 20 Jun 2024
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of a Novel Post-Operative Thoracolumosacral Orthosis for Prevention of Proximal Junctional Kyphosis After Adult Spinal Deformity Surgery
- ClinicalTrials.gov ID
- NCT06491030
- Acronym / sponsor ID
- 2023-2446
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Collaborators
- Aspen Medical Products
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracolumosacral Orthosis | Experimental | Device: Align PJK™ TLSO bracePatients 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 |
| No brace | Placebo comparator | Other: Standard of CarePatients 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 may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
- Those with a neuromuscular etiology for their deformity (i.e. Parkinson's disease, cerebral palsy, post-stroke, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Align PJK™ TLSO bracePatients will get randomized to receiving and wearing a back brace for 6 weeks postoperatively. | Device | Thoracolumosacral Orthosis |
| Standard of CarePatients will receive the standard of care postoperative instructions without a brace | Other | No brace |
Primary outcome
The incidence of proximal junctional kyphosis development
Time frame: This will be measured via scoliosis radiographs at the pre discharge, 6-week, and 6-month time points.
As defined by a proximal junctional angle both ≥10° and 10°greater than pre-operative values.
2 secondary outcomes
Change in patient reported outcome measures
Time frame: 6 week and 6-month time points
Change in patient reported outcome measures
Time frame: 6 week and 6-month time points
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
Related trials for Proximal Junctional Kyphosis
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Retrospective Evaluation of Upper Instrumented Vertebrae (UIV) Screw Loosening Following Spine Surgery
Thoracolumbar Spinal Fusion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Align PJK™ TLSO brace in people with Proximal Junctional Kyphosis and Adult Spinal Deformity Surgery, run by Hospital for Special Surgery, New York at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of proximal junctional kyphosis development (time frame: This will be measured via scoliosis radiographs at the pre discharge, 6-week, and 6-month time points.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.