Adult Spinal DeformityCSSAASDNCT06470152
A Novel Classification of Sagittal Spinal Alignment to Aid Surgical Planning for Adult Spinal Deformity
A study testing Correction strategy in reference to our PI-dependent clustering of sagittal alignment and Correction strategy in reference to the SAAS score in people with Adult Spinal Deformity and Sagittal Deformity, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
Surgical outcomes, including radiographic outcomes, patient-reported outcomes, postoperative complications, and revision surgery rates, were compared in patients with adult spinal deformity who underwent correction surgery with reference to our pelvic incidence-dependent (PI-dependent) clustering of sagittal spinal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Spinal Deformity, Sagittal Deformity, Sagittal Alignment
- What is being tested?
- Correction strategy in reference to our PI-dependent clustering of sagittal alignment and Correction strategy in reference to the SAAS score
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 1 Dec 2027
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age at the time of treatment;
- Complete radiographic data, including standing posteroanterior and lateral whole-spine radiographs, lumbar computed tomography, and lumbar magnetic resonance imaging;
- Radiographic evidence of ASD: sagittal vertical axis ≥ 50 mm, pelvic tilt ≥ 25°, pelvic incidence-lumbar lordosis mismatch ≥ 10°, and/or thoracic kyphosis ≥ 60°.
Who cannot join
- Any type of previous spinal surgery;
- Other musculoskeletal problems impeding walking ability, syndromic or neuromuscular diseases such as Parkinson\'s disease, inflammatory conditions such as ankylosing spondylitis, infectious conditions such as spinal tuberculosis, metabolic diseases such as severe osteoporosis, and/or serious general medical conditions such as sepsis or malignancy;
- Pathology of deformity as follows: post-traumatic deformity, adult idiopathic scoliosis of the thoracic spine, or de-novo lumbar scoliosis;
- Hip joint Kellgren-Lawrence grade ≥ II, history of hip joint and/or knee joint pain, and/or previous joint replacement.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100053
Dongfan Wang, 13821337116, wdfdoctor@126.com
About this study
Official title: Pelvic Incidence-Dependent Clustering of Sagittal Spinal Alignment: A Novel Classification to Aid Surgical Planning for Adult Spinal Deformity
Surgical outcomes, including radiographic outcomes, patient-reported outcomes, postoperative complications, and revision surgery rates, were compared in patients with adult spinal deformity who underwent correction surgery with reference to our pelvic incidence-dependent (PI-dependent) clustering of sagittal spinal alignment and existing standards (sagittal age-adjusted score [SAAS], global alignment and proportion [GAP] score, and Roussouly classification). Our findings may provide tangible guidance for surgical decision-making in ASD.
- Being tested
- Correction strategy in reference to our PI-dependent clustering of sagittal alignment, Correction strategy in reference to the SAAS score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Correction strategy in reference to our PI-dependent clustering of sagittal alignmentProcedure or surgery
For type I patients (PI < 39.56°), the target LL = -0.13*PI2+9.36*PI-134.08; for type II patients (39.56° ≤ PI < 49.16°), the target LL = 0.45*PI+26.57; for type III patients (49.16° ≤ PI < 58.31°), the target LL = -0.15*PI2+17.09*PI-420.57; for type IV patients (PI > 58.31°), the target LL = 0.06*PI2-7.55*PI+289.77. Prediction intervals of 95% confidence is adopted as the target LL range.
Correction strategy in reference to the SAAS scoreProcedure or surgery
This new score is composed of three sagittal parameters (PI-LL, PT and TPA). For these three parameters, points were assigned based on offset with age-adjusted targets 0 points if the parameter was within 10 years of the patient's age (Match). For each 20 years above the age-adjusted target, 1 point was added (e.g., + 1 point between + 10 and + 30, + 2 points between +30 and +50). Conversely, 1 point was subtracted for each 20 years below the age-adjusted target (e.g., -1 point between -10 and -30, -2 points between -30 and -50). SAAS was calculated by adding all 3 components, creating a discreet score that could have a negative value (under corrected) or positive value (over corrected). SAAS was sub-categorized into "SAAS-Under" if it was less than -1, "SAAS-Match" if it was between -1 and + 1 or "SAAS-Over" if it was greater than + 1.
| Study group | Role | What they receive |
|---|---|---|
| Patients with ASD undergoing correction surgery in reference to our novel criteria | Experimental | Correcting deformity according to the PI-dependent clustering of sagittal spinal alignment. Receives: Procedure: Correction strategy in reference to our PI-dependent clustering of sagittal alignment |
| Patients with ASD undergoing correction surgery in reference to SAAS score. | Other | Correcting deformity according to the SAAS score. Receives: Procedure: Correction strategy in reference to the SAAS score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proximal Junctional Kyphosis
Proximal junctional kyphosis (PJK) was defined by a proximal junctional angle (PJA) (Cobb angle between the superior endplate of UIV+2 and inferior endplate of UIV) of > 10° and a PJA angle difference of > 10° from baseline at any time point up to latest follow-up.
Measured: Two years after surgery
Secondary outcomes (3)
Scoliosis Research Society-22
The 22-item SRS-22r questionnaire is specific to scoliosis-related patient-reported outcomes, and consists of 6 domains: function, pain, self-image, mental health, satisfaction, and subtotal, with each domain being scored from 1 to 5 where higher scores correspond to better patient outcomes.
Measured: One month, 3 months, 6 months, 1 year, and 2 years after surgery
Oswestry disability index
The validated ODI is a self-administered questionnaire for evaluating back-specific functional disability, consisting of 10 items with scores from 0 to 5, and higher ODI indicates more severe disability.
Measured: One month, 3 months, 6 months, 1 year, and 2 years after surgery
Achievement of minimal clinically important difference
A prespecified MCID of 10 points was used for the ODI. The minimum clinically important difference (MCID) values for the SRS-22r based on data from a Japanese cohort have previously been reported as follows: function = 0.90, pain = 0.85, self-image = 1.05, mental health = 0.70, and subtotal = 1.05.
Measured: Two years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Spinal DeformityStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06470152
- Sponsor's protocol ID
- xuanwu_ASD
- Acronym
- CSSAASD
- Status last verified
- Jun 2024
- First submitted
- 17 Jun 2024
- Last updated
- 24 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Incidence-Dependent Clustering of Sagittal Spinal Alignment: A Novel Classification to Aid Surgical Planning for Adult Spinal Deformity
- ClinicalTrials.gov ID
- NCT06470152
- Acronym / sponsor ID
- CSSAASD / xuanwu_ASD
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 24 Jun 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.
Surgical outcomes, including radiographic outcomes, patient-reported outcomes, postoperative complications, and revision surgery rates, were compared in patients with adult spinal deformity who underwent correction surgery with reference to our pelvic incidence-dependent (PI-dependent) clustering of sagittal spinal alignment and existing standards (sagittal age-adjusted score [SAAS], global alignment and proportion [GAP] score, and Roussouly classification). Our findings may provide tangible guidance for surgical decision-making in ASD.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with ASD undergoing correction surgery in reference to our novel criteria | Experimental | Procedure: Correction strategy in reference to our PI-dependent clustering of sagittal alignmentCorrecting deformity according to the PI-dependent clustering of sagittal spinal alignment. |
| Patients with ASD undergoing correction surgery in reference to SAAS score. | Other | Procedure: Correction strategy in reference to the SAAS scoreCorrecting deformity according to the SAAS score. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 18 years of age at the time of treatment;
- Complete radiographic data, including standing posteroanterior and lateral whole-spine radiographs, lumbar computed tomography, and lumbar magnetic resonance imaging;
- Radiographic evidence of ASD: sagittal vertical axis ≥ 50 mm, pelvic tilt ≥ 25°, pelvic incidence-lumbar lordosis mismatch ≥ 10°, and/or thoracic kyphosis ≥ 60°.
Key exclusion criteria (4 listed)
- Any type of previous spinal surgery;
- Other musculoskeletal problems impeding walking ability, syndromic or neuromuscular diseases such as Parkinson\'s disease, inflammatory conditions such as ankylosing spondylitis, infectious conditions such as spinal tuberculosis, metabolic diseases such as severe osteoporosis, and/or serious general medical conditions such as sepsis or malignancy;
- Pathology of deformity as follows: post-traumatic deformity, adult idiopathic scoliosis of the thoracic spine, or de-novo lumbar scoliosis;
- Hip joint Kellgren-Lawrence grade ≥ II, history of hip joint and/or knee joint pain, and/or previous joint replacement.
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 |
|---|---|---|
| Correction strategy in reference to our PI-dependent clustering of sagittal alignmentFor type I patients (PI < 39.56°), the target LL = -0.13*PI2+9.36*PI-134.08; for type II patients (39.56° ≤ PI < 49.16°), the target LL = 0.45*PI+26.57; for type III patients (49.16° ≤ PI < 58.31°), the target LL = -0.15*PI2+17.09*PI-420.57; for type IV patients (PI > 58.31°), the target LL = 0.06*PI2-7.55*PI+289.77. Prediction intervals of 95% confidence is adopted as the target LL range. | Procedure or surgery | Patients with ASD undergoing correction surgery in reference to our novel criteria |
| Correction strategy in reference to the SAAS scoreThis new score is composed of three sagittal parameters (PI-LL, PT and TPA). For these three parameters, points were assigned based on offset with age-adjusted targets 0 points if the parameter was within 10 years of the patient's age (Match). For each 20 years above the age-adjusted target, 1 point was added (e.g., + 1 point between + 10 and + 30, + 2 points between +30 and +50). Conversely, 1 point was subtracted for each 20 years below the age-adjusted target (e.g., -1 point between -10 and -30, -2 points between -30 and -50). SAAS was calculated by adding all 3 components, creating a discreet score that could have a negative value (under corrected) or positive value (over corrected). SAAS was sub-categorized into "SAAS-Under" if it was less than -1, "SAAS-Match" if it was between -1 and + 1 or "SAAS-Over" if it was greater than + 1. | Procedure or surgery | Patients with ASD undergoing correction surgery in reference to SAAS score. |
Primary outcome
Proximal Junctional Kyphosis
Time frame: Two years after surgery
Proximal junctional kyphosis (PJK) was defined by a proximal junctional angle (PJA) (Cobb angle between the superior endplate of UIV+2 and inferior endplate of UIV) of > 10° and a PJA angle difference of > 10° from baseline at any time point up to latest follow-up.
3 secondary outcomes
Scoliosis Research Society-22
Time frame: One month, 3 months, 6 months, 1 year, and 2 years after surgery
Oswestry disability index
Time frame: One month, 3 months, 6 months, 1 year, and 2 years after surgery
Achievement of minimal clinically important difference
Time frame: Two years after surgery
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 24 Jun 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Correction strategy in reference to our PI-dependent clustering of sagittal alignment and Correction strategy in reference to the SAAS score in people with Adult Spinal Deformity and Sagittal Deformity, run by Xuanwu Hospital, Beijing at 1 site in China.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Contact Shibao Lu, M.D. (18810728213, wdfdoctor@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proximal Junctional Kyphosis (time frame: Two years after surgery). 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 24 Jun 2024.