Degenerative ScoliosisDLSNCT05485636
Degenerative Lumbar Scoliosis
An observational study of Degenerative Scoliosis and Scoliosis Lumbar Region, run by Peking University Third Hospital at 8 sites in China.
Trial summary
This is a retrospective, observational multi-center study. The participants undergone lumbar spine surgery for degenerative lumbar scoliosis and followed up for at least 2 years are retrospectively enrolled from 8 centers. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Degenerative Scoliosis, Scoliosis Lumbar Region
- How many people
- 640 participants
- Where
- 8 sitesChina
- Study dates
- 1 Aug 2022to 1 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In the orthopaedic department of the eight medical centers, patients undergone spinal surgery for degenerative lumbar scoliosis are invited to participate in the study.
Who may be able to join
- age ≥ 60 years old
- diagnosed with degenerative lumbar scoliosis with X-ray before surgery
- Cobb angle of the major curve ≥ 20°
- with signs and/or symptoms of low back pain and/or leg pain, torso imbalance, and spinal nerve compression
- followed up for at least 2 years after the surgery
Who cannot join
- scoliosis caused by infection, trauma or tumor.
- classified as adult idiopathic scoliosis, congenital scoliosis, and scoliosis caused by neuromuscular diseases
- previous history of spinal surgery
Trial locations and contacts
8 sites in 1 country.
Zhuoran Sun, M.D. contact
8 sites in 1 country
China8 sites, 8 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Weishi Li, M.D., (+86010)62017691-7011, puh3liweishi@163.com
Zhuoran Sun, puh3_szr@163.com
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Limin Liu, M.D., 18980601394@163.com
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Xinyu Liu, M.D., newyuliu@163.com
- Recruiting
The First People's Hospital of Yunnan Province
Kunming, Yunnan, 650032
Sheng Lu, M.D., drlusheng@163.com
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330019
Haoqun Yao, M.D., yaohaoqun@sina.com
- Recruiting
The Third Affiliated Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050051
Wenyuan Ding, M.D., dingwyster@163.com
- Recruiting
Tianjin Hospital
Tianjin, Tianjin Municipality, 300210
Qiang Yang, M.D., yangqiang1980@126.com
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
Yanzheng Gao, M.D., doctorgao63@163.com
About this study
Official title: Degenerative Lumbar Scoliosis: a Multi-center Study
This is a retrospective, observational multi-center study. The participants undergone lumbar spine surgery for degenerative lumbar scoliosis and followed up for at least 2 years are retrospectively enrolled from 8 centers. This study mainly focuses on the short-term and long-term outcomes of lumbar surgery in participants with degenerative lumbar scoliosis, and that how much the surgical outcomes are related with demographic, surgical, and radiographic features before and after surgery. The objective is to offer more detailed clinical evidence to guide the surgical strategy development for degenerative lumbar scoliosis.
Read the detailed description
Degenerative lumbar scoliosis is a spinal deformity that typically develops among adults over 50 years old. Characterized with low back pain, leg pain and abnormal body posture to various degrees, patients are mostly offered conservative treatment in early stages, and then resort to surgical treatment when medication fail to achieve alleviation. The surgical procedures to treat degenerative lumbar scoliosis include spinal decompression, fusion, and instrumentation, or a combination of several of the above. Osteotomy is generally required when it comes to rigid deformity. However, surgical treatment strategies are complicated by factors comprising osteoporosis, paraspinal muscle degeneration, common yet severe postoperative complications resulting from specific surgical methods, and chronic metabolic diseases and so on. A detailed and individualized surgical planning has been under debate and development continuously. Also, most previous classifications and researches are centered on the population of the white. Representative data of the yellow people, especially Chinese people, from multicentric studies are scarce.
Patients undergone surgeries for degenerative lumbar scoliosis in 8 hospitals in China between 2010 and 2020 are retrospectively selected and enrolled. Patients' clinical data from pre-operation, post-operation and the last follow-up are revaluated. General patient data are collected after informed consent, such as age, gender, height, weight, body mass index and bone mineral density measured in T-scores, together with surgical data including operation duration, blood loss, physical status grades based on the American Society of Anesthesiologists Classification, surgical approaches, upper instrumented vertebra, lowest instrumented vertebra, osteotomy grades based on Schwab Classification, osteotomy levels, lumbosacral curve levelling approaches, cemented vertebrae, and perioperative complications. Radiographic parameters of the spine are also measured from X-rays, including the upper end vertebra of the major curve, apical vertebral translation, Cobb angles of the major and fractional curves, coronal balance distance, coronal classification of the deformity based on the Drum Tower Classification, L4 and L5 tilt on the coronal plane, lumbar tilt, thoracic kyphosis, lumbar lordosis, thoracolumbar kyphosis, sagittal vertical axis, T1 pelvic angle, pelvic tilt, sacral slope, L4-S1 lordotic angle, and proximal junctional angle. Clinical outcomes assessed with Japanese Orthopaedic Association score, Oswestry Disability Index and visual analogue scale of leg/back pain are also gathered. Correlation between demographic, surgical, and radiographic parameters and clinical outcomes are statistically explored, in order to find indexes that help group and match patients with their optimum surgical strategies.
- Conditions
- Degenerative Scoliosis, Scoliosis Lumbar Region
- Keywords
- degenerative, lumbar, scoliosis, outcome
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| degenerative lumbar scoliosis postoperative group | This group contains patients who have undergone spinal surgery for degenerative lumbar scoliosis. No interventions are designed to be administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical complications
Mechanical complications at the last follow-up, including proximal junctional kyphosis, proximal junctional failure, distal junctional kyphosis, distal junctional failure, instrument breakage, pedicle screw loosening, pseudoarthrosis, and others.
Measured: 24 months
Secondary outcomes (5)
Radiological angular parameters
Radiological angular parameters measured on anteroposterior and lateral radiographs, including: 1) major and lumbosacral Cobb angle, 2) L4, L5 and upper instrumented vertebra (UIV) tilt, 3)T1-UIV Cobb angle, 4) thoracic kyphosis, 5) lumbar lordosis, 6) thoracolumbar kyphosis, 7) T1 pelvic angle, 8) pelvic incidence, 9) pelvic tilt, 10) sacral slope, 11) lordosis tilt, 12) proximal junctional angle, and 13) L4-S1 lumbar lordosis.
Measured: 3 months, 6 months, 12 months, 24 months
Radiological distance parameters
Radiological distance parameters measured on anteroposterior and lateral radiographs, including: 1) coronal balance distance, 2) sagittal vertical axis, 3) apical vertebral translation.
Measured: 3 months, 6 months, 12 months, 24 months
Back pain
The Visual Analogue Scale (VAS 0-10) is adopted to evaluate back pain, with higher scores indicating severer pain.
Measured: 3 months, 6 months, 12 months, 24 months
Leg pain
The Visual Analogue Scale (VAS 0-10) is adopted to evaluate leg pain, with higher scores indicating severer pain.
Measured: 3 months, 6 months, 12 months, 24 months
Disability
The Japanese Orthopaedic Association (JOA 0-29) Scores is used to assess disability, with lower scores indicating severer disability. The Oswestry Disability Index (ODI 0-100%) is also used to assess disability, with higher percentages indicating severer disability.
Measured: 3 months, 6 months, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start1 Aug 2022
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Degenerative ScoliosisStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 640 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hebei Medical University Third Hospital, Tianjin Hospital, West China Hospital, Qilu Hospital of Shandong University, The First Affiliated Hospital of Nanchang University, Henan Provincial People's Hospital, The First People's Hospital of Yunnan
- Responsible party
- Sponsor
- Investigators
- Weishi Li, M.D., Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05485636
- Sponsor's protocol ID
- M2022381
- Acronym
- DLS
- Status last verified
- Jul 2022
- First submitted
- 4 Jul 2022
- Last updated
- 1 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will make the clinical study report available half a year after the publication of the results of the study.
Publications
Pritchett JW, Bortel DT. Degenerative symptomatic lumbar scoliosis. Spine (Phila Pa 1976). 1993 May;18(6):700-3. doi: 10.1097/00007632-199305000-00004.
PubMed 8516697Oskouian RJ Jr, Shaffrey CI. Degenerative lumbar scoliosis. Neurosurg Clin N Am. 2006 Jul;17(3):299-315, vii. doi: 10.1016/j.nec.2006.05.002.
PubMed 16876030Koerner JD, Reitman CA, Arnold PM, Rihn J. Degenerative Lumbar Scoliosis. JBJS Rev. 2015 Apr 7;3(4):e1. doi: 10.2106/JBJS.RVW.N.00061. No abstract available.
PubMed 27490255Xu L, Sun X, Huang S, Zhu Z, Qiao J, Zhu F, Mao S, Ding Y, Qiu Y. Degenerative lumbar scoliosis in Chinese Han population: prevalence and relationship to age, gender, bone mineral density, and body mass index. Eur Spine J. 2013 Jun;22(6):1326-31. doi: 10.1007/s00586-013-2678-8. Epub 2013 Jan 30.
PubMed 23361532Schwab F, Dubey A, Gamez L, El Fegoun AB, Hwang K, Pagala M, Farcy JP. Adult scoliosis: prevalence, SF-36, and nutritional parameters in an elderly volunteer population. Spine (Phila Pa 1976). 2005 May 1;30(9):1082-5. doi: 10.1097/01.brs.0000160842.43482.cd.
PubMed 15864163Jimbo S, Kobayashi T, Aono K, Atsuta Y, Matsuno T. Epidemiology of degenerative lumbar scoliosis: a community-based cohort study. Spine (Phila Pa 1976). 2012 Sep 15;37(20):1763-70. doi: 10.1097/BRS.0b013e3182575eaa.
PubMed 22487710Diebo B, Liu S, Lafage V, Schwab F. Osteotomies in the treatment of spinal deformities: indications, classification, and surgical planning. Eur J Orthop Surg Traumatol. 2014 Jul;24 Suppl 1:S11-20. doi: 10.1007/s00590-014-1471-7. Epub 2014 May 11.
PubMed 24816823Protopsaltis T, Schwab F, Bronsard N, Smith JS, Klineberg E, Mundis G, Ryan DJ, Hostin R, Hart R, Burton D, Ames C, Shaffrey C, Bess S, Errico T, Lafage V; International Spine Study Group. TheT1 pelvic angle, a novel radiographic measure of global sagittal deformity, accounts for both spinal inclination and pelvic tilt and correlates with health-related quality of life. J Bone Joint Surg Am. 2014 Oct 1;96(19):1631-40. doi: 10.2106/JBJS.M.01459.
PubMed 25274788Diebo BG, Oren JH, Challier V, Lafage R, Ferrero E, Liu S, Vira S, Spiegel MA, Harris BY, Liabaud B, Henry JK, Errico TJ, Schwab FJ, Lafage V. Global sagittal axis: a step toward full-body assessment of sagittal plane deformity in the human body. J Neurosurg Spine. 2016 Oct;25(4):494-499. doi: 10.3171/2016.2.SPINE151311. Epub 2016 May 20.
PubMed 27203811Bao H, Yan P, Qiu Y, Liu Z, Zhu F. Coronal imbalance in degenerative lumbar scoliosis: Prevalence and influence on surgical decision-making for spinal osteotomy. Bone Joint J. 2016 Sep;98-B(9):1227-33. doi: 10.1302/0301-620X.98B9.37273.
PubMed 27587525Wang H, Wang L, Sun Z, Jiang S, Li W. Posterior column osteotomy plus unilateral cage strutting for correction of lumbosacral fractional curve in degenerative lumbar scoliosis. J Orthop Surg Res. 2020 Oct 20;15(1):482. doi: 10.1186/s13018-020-02011-y.
PubMed 33081812Schwab FJ, Smith VA, Biserni M, Gamez L, Farcy JP, Pagala M. Adult scoliosis: a quantitative radiographic and clinical analysis. Spine (Phila Pa 1976). 2002 Feb 15;27(4):387-92. doi: 10.1097/00007632-200202150-00012.
PubMed 11840105Schwab FJ, Blondel B, Bess S, Hostin R, Shaffrey CI, Smith JS, Boachie-Adjei O, Burton DC, Akbarnia BA, Mundis GM, Ames CP, Kebaish K, Hart RA, Farcy JP, Lafage V; International Spine Study Group (ISSG). Radiographical spinopelvic parameters and disability in the setting of adult spinal deformity: a prospective multicenter analysis. Spine (Phila Pa 1976). 2013 Jun 1;38(13):E803-12. doi: 10.1097/BRS.0b013e318292b7b9.
PubMed 23722572Schwab F, Blondel B, Chay E, Demakakos J, Lenke L, Tropiano P, Ames C, Smith JS, Shaffrey CI, Glassman S, Farcy JP, Lafage V. The comprehensive anatomical spinal osteotomy classification. Neurosurgery. 2014 Jan;74(1):112-20; discussion 120. doi: 10.1227/NEU.0000000000000182o.
PubMed 24356197Toyone T, Shiboi R, Ozawa T, Inada K, Shirahata T, Kamikawa K, Watanabe A, Matsuki K, Ochiai S, Kaiho T, Morikawa Y, Sota K, Yasuchika A, Gen I, Sumihisa O, Ohtori S, Takahashi K, Wada Y. Asymmetrical pedicle subtraction osteotomy for rigid degenerative lumbar kyphoscoliosis. Spine (Phila Pa 1976). 2012 Oct 1;37(21):1847-52. doi: 10.1097/BRS.0b013e31825bf644.
PubMed 22565386
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Degenerative Lumbar Scoliosis: a Multi-center Study
- ClinicalTrials.gov ID
- NCT05485636
- Acronym / sponsor ID
- DLS / M2022381
- Conditions
- Degenerative Scoliosis, Scoliosis Lumbar Region
- Keywords
- degenerative, lumbar, scoliosis, outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 640 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Hebei Medical University Third Hospital, Tianjin Hospital, West China Hospital, Qilu Hospital of Shandong University, The First Affiliated Hospital of Nanchang University, Henan Provincial People's Hospital, The First People's Hospital of Yunnan
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 3 Aug 2022 (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.
This is a retrospective, observational multi-center study. The participants undergone lumbar spine surgery for degenerative lumbar scoliosis and followed up for at least 2 years are retrospectively enrolled from 8 centers. This study mainly focuses on the short-term and long-term outcomes of lumbar surgery in participants with degenerative lumbar scoliosis, and that how much the surgical outcomes are related with demographic, surgical, and radiographic features before and after surgery. The objective is to offer more detailed clinical evidence to guide the surgical strategy development for degenerative lumbar scoliosis.
Detailed description
Degenerative lumbar scoliosis is a spinal deformity that typically develops among adults over 50 years old. Characterized with low back pain, leg pain and abnormal body posture to various degrees, patients are mostly offered conservative treatment in early stages, and then resort to surgical treatment when medication fail to achieve alleviation. The surgical procedures to treat degenerative lumbar scoliosis include spinal decompression, fusion, and instrumentation, or a combination of several of the above. Osteotomy is generally required when it comes to rigid deformity. However, surgical treatment strategies are complicated by factors comprising osteoporosis, paraspinal muscle degeneration, common yet severe postoperative complications resulting from specific surgical methods, and chronic metabolic diseases and so on. A detailed and individualized surgical planning has been under debate and development continuously. Also, most previous classifications and researches are centered on the population of the white. Representative data of the yellow people, especially Chinese people, from multicentric studies are scarce.
Patients undergone surgeries for degenerative lumbar scoliosis in 8 hospitals in China between 2010 and 2020 are retrospectively selected and enrolled. Patients' clinical data from pre-operation, post-operation and the last follow-up are revaluated. General patient data are collected after informed consent, such as age, gender, height, weight, body mass index and bone mineral density measured in T-scores, together with surgical data including operation duration, blood loss, physical status grades based on the American Society of Anesthesiologists Classification, surgical approaches, upper instrumented vertebra, lowest instrumented vertebra, osteotomy grades based on Schwab Classification, osteotomy levels, lumbosacral curve levelling approaches, cemented vertebrae, and perioperative complications. Radiographic parameters of the spine are also measured from X-rays, including the upper end vertebra of the major curve, apical vertebral translation, Cobb angles of the major and fractional curves, coronal balance distance, coronal classification of the deformity based on the Drum Tower Classification, L4 and L5 tilt on the coronal plane, lumbar tilt, thoracic kyphosis, lumbar lordosis, thoracolumbar kyphosis, sagittal vertical axis, T1 pelvic angle, pelvic tilt, sacral slope, L4-S1 lordotic angle, and proximal junctional angle. Clinical outcomes assessed with Japanese Orthopaedic Association score, Oswestry Disability Index and visual analogue scale of leg/back pain are also gathered. Correlation between demographic, surgical, and radiographic parameters and clinical outcomes are statistically explored, in order to find indexes that help group and match patients with their optimum surgical strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| degenerative lumbar scoliosis postoperative group | – | –This group contains patients who have undergone spinal surgery for degenerative lumbar scoliosis. No interventions are designed to be administered. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In the orthopaedic department of the eight medical centers, patients undergone spinal surgery for degenerative lumbar scoliosis are invited to participate in the study.
Key inclusion criteria (5 listed)
- age ≥ 60 years old
- diagnosed with degenerative lumbar scoliosis with X-ray before surgery
- Cobb angle of the major curve ≥ 20°
- with signs and/or symptoms of low back pain and/or leg pain, torso imbalance, and spinal nerve compression
- followed up for at least 2 years after the surgery
Key exclusion criteria (3 listed)
- scoliosis caused by infection, trauma or tumor.
- classified as adult idiopathic scoliosis, congenital scoliosis, and scoliosis caused by neuromuscular diseases
- previous history of spinal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mechanical complications
Time frame: 24 months
Mechanical complications at the last follow-up, including proximal junctional kyphosis, proximal junctional failure, distal junctional kyphosis, distal junctional failure, instrument breakage, pedicle screw loosening, pseudoarthrosis, and others.
5 secondary outcomes
Radiological angular parameters
Time frame: 3 months, 6 months, 12 months, 24 months
Radiological distance parameters
Time frame: 3 months, 6 months, 12 months, 24 months
Back pain
Time frame: 3 months, 6 months, 12 months, 24 months
Leg pain
Time frame: 3 months, 6 months, 12 months, 24 months
Disability
Time frame: 3 months, 6 months, 12 months, 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
- Background: PubMed 8516697Pritchett JW, Bortel DT. Degenerative symptomatic lumbar scoliosis. Spine (Phila Pa 1976). 1993 May;18(6):700-3. doi: 10.1097/00007632-199305000-00004.
- Background: PubMed 16876030Oskouian RJ Jr, Shaffrey CI. Degenerative lumbar scoliosis. Neurosurg Clin N Am. 2006 Jul;17(3):299-315, vii. doi: 10.1016/j.nec.2006.05.002.
- Background: PubMed 27490255Koerner JD, Reitman CA, Arnold PM, Rihn J. Degenerative Lumbar Scoliosis. JBJS Rev. 2015 Apr 7;3(4):e1. doi: 10.2106/JBJS.RVW.N.00061. No abstract available.
- Background: PubMed 23361532Xu L, Sun X, Huang S, Zhu Z, Qiao J, Zhu F, Mao S, Ding Y, Qiu Y. Degenerative lumbar scoliosis in Chinese Han population: prevalence and relationship to age, gender, bone mineral density, and body mass index. Eur Spine J. 2013 Jun;22(6):1326-31. doi: 10.1007/s00586-013-2678-8. Epub 2013 Jan 30.
- Background: PubMed 15864163Schwab F, Dubey A, Gamez L, El Fegoun AB, Hwang K, Pagala M, Farcy JP. Adult scoliosis: prevalence, SF-36, and nutritional parameters in an elderly volunteer population. Spine (Phila Pa 1976). 2005 May 1;30(9):1082-5. doi: 10.1097/01.brs.0000160842.43482.cd.
- Background: PubMed 22487710Jimbo S, Kobayashi T, Aono K, Atsuta Y, Matsuno T. Epidemiology of degenerative lumbar scoliosis: a community-based cohort study. Spine (Phila Pa 1976). 2012 Sep 15;37(20):1763-70. doi: 10.1097/BRS.0b013e3182575eaa.
- Background: PubMed 24816823Diebo B, Liu S, Lafage V, Schwab F. Osteotomies in the treatment of spinal deformities: indications, classification, and surgical planning. Eur J Orthop Surg Traumatol. 2014 Jul;24 Suppl 1:S11-20. doi: 10.1007/s00590-014-1471-7. Epub 2014 May 11.
- Background: PubMed 25274788Protopsaltis T, Schwab F, Bronsard N, Smith JS, Klineberg E, Mundis G, Ryan DJ, Hostin R, Hart R, Burton D, Ames C, Shaffrey C, Bess S, Errico T, Lafage V; International Spine Study Group. TheT1 pelvic angle, a novel radiographic measure of global sagittal deformity, accounts for both spinal inclination and pelvic tilt and correlates with health-related quality of life. J Bone Joint Surg Am. 2014 Oct 1;96(19):1631-40. doi: 10.2106/JBJS.M.01459.
- Background: PubMed 27203811Diebo BG, Oren JH, Challier V, Lafage R, Ferrero E, Liu S, Vira S, Spiegel MA, Harris BY, Liabaud B, Henry JK, Errico TJ, Schwab FJ, Lafage V. Global sagittal axis: a step toward full-body assessment of sagittal plane deformity in the human body. J Neurosurg Spine. 2016 Oct;25(4):494-499. doi: 10.3171/2016.2.SPINE151311. Epub 2016 May 20.
- Background: PubMed 27587525Bao H, Yan P, Qiu Y, Liu Z, Zhu F. Coronal imbalance in degenerative lumbar scoliosis: Prevalence and influence on surgical decision-making for spinal osteotomy. Bone Joint J. 2016 Sep;98-B(9):1227-33. doi: 10.1302/0301-620X.98B9.37273.
- Background: PubMed 33081812Wang H, Wang L, Sun Z, Jiang S, Li W. Posterior column osteotomy plus unilateral cage strutting for correction of lumbosacral fractional curve in degenerative lumbar scoliosis. J Orthop Surg Res. 2020 Oct 20;15(1):482. doi: 10.1186/s13018-020-02011-y.
- Background: PubMed 11840105Schwab FJ, Smith VA, Biserni M, Gamez L, Farcy JP, Pagala M. Adult scoliosis: a quantitative radiographic and clinical analysis. Spine (Phila Pa 1976). 2002 Feb 15;27(4):387-92. doi: 10.1097/00007632-200202150-00012.
- Individual participant dataSharing planned: Yes. We will make the clinical study report available half a year after the publication of the results of the study.
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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. This study is not recruiting at the moment.
Zhuoran Sun, M.D. contact
Weishi Li, M.D. principal investigator
Peking University Third Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Scoliosis and Scoliosis Lumbar Region, run by Peking University Third Hospital at 8 sites 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weishi Li, M.D. ((+86010)62017691-7011, puh3liweishi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mechanical complications (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05485636, which also lists 23 linked publications.
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 1 Dec 2022.