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| Name | Class |
|---|---|
| Aspen Medical Products | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thoracolumosacral Orthosis | Experimental | Patients randomized to this arm will be fitted with an Aspen Medical Products "Align PJKâ„¢" 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 | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Align PJKâ„¢ TLSO brace | Device | Patients will get randomized to receiving and wearing a back brace for 6 weeks postoperatively. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of proximal junctional kyphosis development | As defined by a proximal junctional angle both ≥10° and 10°greater than pre-operative values. | This will be measured via scoliosis radiographs at the pre discharge, 6-week, and 6-month time points. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in patient reported outcome measures | VAS leg pain, and VAS back pain (scale of 0-10). 0= no pain; 10=worst possible pain | 6 week and 6-month time points |
| Change in patient reported outcome measures |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana Spine Group | Active, not recruiting | Carmel | Indiana | 46032 | United States | |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of Care | Other | Patients will receive the standard of care postoperative instructions without a brace |
|
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)
| 6 week and 6-month time points |
| University of Kansas |
| Active, not recruiting |
| Overland Park |
| Kansas |
| 66211 |
| United States |
| Hospital for Special Surgery | Recruiting | New York | New York | 10021 | United States |
|
| University of Texas Health, Houston | Active, not recruiting | Bellaire | Texas | 77401 | United States |
| Texas Back Institute | Active, not recruiting | Dallas | Texas | 75243 | United States |
| Virgina Mason Franciscan Health | Active, not recruiting | Seattle | Washington | 98101 | United States |