Isthmic SpondylolisthesisNCT04968626
Relationship Between Spinopelvic Parameters and Clinical Symptoms of Low-grade Lumbar Isthmic Spondylolisthesis
A study testing PI-LL in people with Isthmic Spondylolisthesis, run by Peking University Third Hospital at 1 site in China.
Trial summary
This was a retrospective study.PI and LL greatly influence IS and its progression. However, relationships between the spinopelvic parameters and clinical symptoms of patients with IS were not fully investigated in previous studies. Read more about this study
- Who is it for?
- Ages 54 to 76 yearsHealthy volunteers can take part
- Conditions the study is for
- Isthmic Spondylolisthesis
- What is being tested?
- PI-LL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteChina
- Study dates
- 19 Mar 2019to 1 May 2021
- Phase
- Interventional
- 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 54 to 76 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- isthmic spondylolisthesis subjects had spondylolisthesis at L4 or L5 (Meyerding grade I-II) with whole-spine standing lateral images
Who cannot join
- spondylolisthesis of other types (Degenerative, dysplastic, etc.);
- Lumbar infection and/or tumor diseases;
- A previous history of lumbar fusion surgery.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
Official title: Relationship Between Spinopelvic Parameters and Clinical Symptoms of Low-grade Lumbar Isthmic Spondylolisthesis: a Retrospective Analysis
This was a retrospective study.PI and LL greatly influence IS and its progression. However, relationships between the spinopelvic parameters and clinical symptoms of patients with IS were not fully investigated in previous studies. Investigators hypothesized that spinopelvic parameters might be related to the clinical symptoms of IS patients. Therefore, the purpose of the present study was to investigate whether differences in spinopelvic parameters, especially spinopelvic alignment, may be associated with the clinical symptoms of low-grade IS patients.
Read the detailed description
Isthmic spondylolisthesis (IS) is one of the most common types of spondylolisthesis, and spinopelvic parameters are closely related to the clinical symptoms of spinal diseases. In this study, investigators attempted to investigate the relationship between spinopelvic parameters and clinical symptoms of patients with low-grade (Meyerding grade I-II) isthmic spondylolisthesis (IS).
A total of 120 patients with low-grade IS and 106 asymptomatic adults were included in this study. Sex, age and body mass index (BMI) were also collected. Various spinopelvic parameters were evaluated in whole-spine standing-position X-rays. The following spinopelvic parameters were measured: pelvic incidence (PI), sacral slope (SS), pelvic tilt (PT) and lumbar lordosis (LL). The clinical symptoms of the IS patients were assessed with the Japanese Orthopaedic Association (JOA) score and the visual analogue scale (VAS). Investigators compared spinopelvic parameters between the asymptomatic adults and the IS patients. Additionally, investigators investigated correlations between spinopelvic parameters and clinical symptoms.
- Conditions
- Isthmic Spondylolisthesis
- Being tested
- PI-LL
- Keywords
- Isthmic Spondylolisthesis, Spinopelvic parameter, Clinical symptom, Pelvic incidence, Lumbar lordosis
- Medical subject headings
- Lordosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PI-LLRadiation
Also called PI-LL mismatch
The pelvic parameters were collected including PI, pelvic tilt (PT), sacral slope (SS) and LL ,and compared between IS patients and the AS group. Besides, spinopelvic malalignment was defined as an absolute value of PI-LL greater than 10.In the IS group,the clinical symptoms were assessed with the Japanese Orthopaedic Association (JOA) score and the visual analogue scale (VAS). We compared spinopelvic parameters between the asymptomatic adults and the IS patients. Additionally, we investigated correlations between spinopelvic parameters and clinical symptoms.
| Study group | Role | What they receive |
|---|---|---|
| IS GROUP | Experimental | Patients who received an operation to treat their isthmic spondylolisthesis (IS, Meyerding grade I-II) Receives: Radiation: PI-LL |
| AS GROUP | No intervention | The asymptomatic adults had no history of severe back pain or spinal trauma |
What is being measured
The primary outcome is the main question the study is designed to answer.
PI
pelvic incidence
Measured: through study completion, an average of 1 year
SS
sacral slope
Measured: through study completion, an average of 1 year
PT
pelvic tilt
Measured: through study completion, an average of 1 year
LL
lumbar lordosis
Measured: through study completion, an average of 1 year
PI-LL
pelvic incidence minus lumbar lordosis
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
VAS
visual analogue scale
Measured: through study completion, an average of 1 year
JOA
The Japanese Orthopaedic Association (JOA)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start19 Mar 2019
- Primary completion1 Jan 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Isthmic SpondylolisthesisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04968626
- Sponsor's protocol ID
- M2019125
- Status last verified
- Mar 2020
- First submitted
- 27 Jun 2021
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Randall RM, Silverstein M, Goodwin R. Review of Pediatric Spondylolysis and Spondylolisthesis. Sports Med Arthrosc Rev. 2016 Dec;24(4):184-187. doi: 10.1097/JSA.0000000000000127.
PubMed 27811518Urrutia J, Cuellar J, Zamora T. Spondylolysis and spina bifida occulta in pediatric patients: prevalence study using computed tomography as a screening method. Eur Spine J. 2016 Feb;25(2):590-5. doi: 10.1007/s00586-014-3480-y. Epub 2014 Jul 29.
PubMed 25070790Ramadorai U, Hire J, DeVine JG, Brodt ED, Dettori JR. Incidental findings on magnetic resonance imaging of the spine in the asymptomatic pediatric population: a systematic review. Evid Based Spine Care J. 2014 Oct;5(2):95-100. doi: 10.1055/s-0034-1386753.
PubMed 25278883Beutler WJ, Fredrickson BE, Murtland A, Sweeney CA, Grant WD, Baker D. The natural history of spondylolysis and spondylolisthesis: 45-year follow-up evaluation. Spine (Phila Pa 1976). 2003 May 15;28(10):1027-35; discussion 1035. doi: 10.1097/01.BRS.0000061992.98108.A0.
PubMed 12768144Duval-Beaupere G, Schmidt C, Cosson P. A Barycentremetric study of the sagittal shape of spine and pelvis: the conditions required for an economic standing position. Ann Biomed Eng. 1992;20(4):451-62. doi: 10.1007/BF02368136.
PubMed 1510296Maciejczak A, Jablonska K, Baczek D, Barnas P, Czternastek M, Dudziak P, Georgiew F, Jagiello-Bajer B, Litwora B, Maslanka P, Konior R, Orzech J. Changes in spino-pelvic alignment after surgical treatment of isthmic spondylolisthesis. Neurol Neurochir Pol. 2014 Jan-Feb;48(1):21-9. doi: 10.1016/j.pjnns.2013.05.001. Epub 2014 Jan 23.
PubMed 24636766Park SJ, Lee CS, Chung SS, Kang KC, Shin SK. Postoperative changes in pelvic parameters and sagittal balance in adult isthmic spondylolisthesis. Neurosurgery. 2011 Jun;68(2 Suppl Operative):355-63; discussion 362-3. doi: 10.1227/NEU.0b013e3182117249.
PubMed 21336205Lafage R, Liabaud B, Diebo BG, Oren JH, Vira S, Pesenti S, Protopsaltis TS, Errico TJ, Schwab FJ, Lafage V. Defining the Role of the Lower Limbs in Compensating for Sagittal Malalignment. Spine (Phila Pa 1976). 2017 Nov 15;42(22):E1282-E1288. doi: 10.1097/BRS.0000000000002157.
PubMed 28306639Minamide A, Yoshida M, Iwahashi H, Simpson AK, Yamada H, Hashizume H, Nakagawa Y, Iwasaki H, Tsutsui S, Kagotani R, Sonekatsu M, Sasaki T, Shinto K, Deguchi T. Minimally invasive decompression surgery for lumbar spinal stenosis with degenerative scoliosis: Predictive factors of radiographic and clinical outcomes. J Orthop Sci. 2017 May;22(3):377-383. doi: 10.1016/j.jos.2016.12.022. Epub 2017 Feb 1.
PubMed 28161236Shi L, Chen Y, Miao J, Shi J, Chen D. Reduction of Slippage Influences Surgical Outcomes of Grade II and III Lumbar Isthmic Spondylolisthesis. World Neurosurg. 2018 Dec;120:e1017-e1023. doi: 10.1016/j.wneu.2018.08.217. Epub 2018 Sep 7.
PubMed 30201580
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Spinopelvic Parameters and Clinical Symptoms of Low-grade Lumbar Isthmic Spondylolisthesis: a Retrospective Analysis
- ClinicalTrials.gov ID
- NCT04968626
- Acronym / sponsor ID
- M2019125
- Conditions
- Isthmic Spondylolisthesis
- Keywords
- Isthmic Spondylolisthesis, Spinopelvic parameter, Clinical symptom, Pelvic incidence, Lumbar lordosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 19 Mar 2019 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 20 Jul 2021 (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 was a retrospective study.PI and LL greatly influence IS and its progression. However, relationships between the spinopelvic parameters and clinical symptoms of patients with IS were not fully investigated in previous studies. Investigators hypothesized that spinopelvic parameters might be related to the clinical symptoms of IS patients. Therefore, the purpose of the present study was to investigate whether differences in spinopelvic parameters, especially spinopelvic alignment, may be associated with the clinical symptoms of low-grade IS patients.
Detailed description
Isthmic spondylolisthesis (IS) is one of the most common types of spondylolisthesis, and spinopelvic parameters are closely related to the clinical symptoms of spinal diseases. In this study, investigators attempted to investigate the relationship between spinopelvic parameters and clinical symptoms of patients with low-grade (Meyerding grade I-II) isthmic spondylolisthesis (IS).
A total of 120 patients with low-grade IS and 106 asymptomatic adults were included in this study. Sex, age and body mass index (BMI) were also collected. Various spinopelvic parameters were evaluated in whole-spine standing-position X-rays. The following spinopelvic parameters were measured: pelvic incidence (PI), sacral slope (SS), pelvic tilt (PT) and lumbar lordosis (LL). The clinical symptoms of the IS patients were assessed with the Japanese Orthopaedic Association (JOA) score and the visual analogue scale (VAS). Investigators compared spinopelvic parameters between the asymptomatic adults and the IS patients. Additionally, investigators investigated correlations between spinopelvic parameters and clinical symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IS GROUP | Experimental | Radiation: PI-LLPatients who received an operation to treat their isthmic spondylolisthesis (IS, Meyerding grade I-II) |
| AS GROUP | No intervention | –The asymptomatic adults had no history of severe back pain or spinal trauma |
Who may qualify
- Ages
- 54 to 76 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- isthmic spondylolisthesis subjects had spondylolisthesis at L4 or L5 (Meyerding grade I-II) with whole-spine standing lateral images
Key exclusion criteria (3 listed)
- spondylolisthesis of other types (Degenerative, dysplastic, etc.);
- Lumbar infection and/or tumor diseases;
- A previous history of lumbar fusion surgery.
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 |
|---|---|---|
| PI-LLAlso: PI-LL mismatchThe pelvic parameters were collected including PI, pelvic tilt (PT), sacral slope (SS) and LL ,and compared between IS patients and the AS group. Besides, spinopelvic malalignment was defined as an absolute value of PI-LL greater than 10.In the IS group,the clinical symptoms were assessed with the Japanese Orthopaedic Association (JOA) score and the visual analogue scale (VAS). We compared spinopelvic parameters between the asymptomatic adults and the IS patients. Additionally, we investigated correlations between spinopelvic parameters and clinical symptoms. | Radiation | IS GROUP |
Primary outcome
PI
Time frame: through study completion, an average of 1 year
pelvic incidence
SS
Time frame: through study completion, an average of 1 year
sacral slope
PT
Time frame: through study completion, an average of 1 year
pelvic tilt
LL
Time frame: through study completion, an average of 1 year
lumbar lordosis
PI-LL
Time frame: through study completion, an average of 1 year
pelvic incidence minus lumbar lordosis
2 secondary outcomes
VAS
Time frame: through study completion, an average of 1 year
JOA
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
- Results publication: PubMed 27811518Randall RM, Silverstein M, Goodwin R. Review of Pediatric Spondylolysis and Spondylolisthesis. Sports Med Arthrosc Rev. 2016 Dec;24(4):184-187. doi: 10.1097/JSA.0000000000000127.
- Results publication: PubMed 25070790Urrutia J, Cuellar J, Zamora T. Spondylolysis and spina bifida occulta in pediatric patients: prevalence study using computed tomography as a screening method. Eur Spine J. 2016 Feb;25(2):590-5. doi: 10.1007/s00586-014-3480-y. Epub 2014 Jul 29.
- Results publication: PubMed 25278883Ramadorai U, Hire J, DeVine JG, Brodt ED, Dettori JR. Incidental findings on magnetic resonance imaging of the spine in the asymptomatic pediatric population: a systematic review. Evid Based Spine Care J. 2014 Oct;5(2):95-100. doi: 10.1055/s-0034-1386753.
- Results publication: PubMed 12768144Beutler WJ, Fredrickson BE, Murtland A, Sweeney CA, Grant WD, Baker D. The natural history of spondylolysis and spondylolisthesis: 45-year follow-up evaluation. Spine (Phila Pa 1976). 2003 May 15;28(10):1027-35; discussion 1035. doi: 10.1097/01.BRS.0000061992.98108.A0.
- Results publication: PubMed 1510296Duval-Beaupere G, Schmidt C, Cosson P. A Barycentremetric study of the sagittal shape of spine and pelvis: the conditions required for an economic standing position. Ann Biomed Eng. 1992;20(4):451-62. doi: 10.1007/BF02368136.
- Results publication: PubMed 24636766Maciejczak A, Jablonska K, Baczek D, Barnas P, Czternastek M, Dudziak P, Georgiew F, Jagiello-Bajer B, Litwora B, Maslanka P, Konior R, Orzech J. Changes in spino-pelvic alignment after surgical treatment of isthmic spondylolisthesis. Neurol Neurochir Pol. 2014 Jan-Feb;48(1):21-9. doi: 10.1016/j.pjnns.2013.05.001. Epub 2014 Jan 23.
- Results publication: PubMed 21336205Park SJ, Lee CS, Chung SS, Kang KC, Shin SK. Postoperative changes in pelvic parameters and sagittal balance in adult isthmic spondylolisthesis. Neurosurgery. 2011 Jun;68(2 Suppl Operative):355-63; discussion 362-3. doi: 10.1227/NEU.0b013e3182117249.
- Results publication: PubMed 28306639Lafage R, Liabaud B, Diebo BG, Oren JH, Vira S, Pesenti S, Protopsaltis TS, Errico TJ, Schwab FJ, Lafage V. Defining the Role of the Lower Limbs in Compensating for Sagittal Malalignment. Spine (Phila Pa 1976). 2017 Nov 15;42(22):E1282-E1288. doi: 10.1097/BRS.0000000000002157.
- Results publication: PubMed 28161236Minamide A, Yoshida M, Iwahashi H, Simpson AK, Yamada H, Hashizume H, Nakagawa Y, Iwasaki H, Tsutsui S, Kagotani R, Sonekatsu M, Sasaki T, Shinto K, Deguchi T. Minimally invasive decompression surgery for lumbar spinal stenosis with degenerative scoliosis: Predictive factors of radiographic and clinical outcomes. J Orthop Sci. 2017 May;22(3):377-383. doi: 10.1016/j.jos.2016.12.022. Epub 2017 Feb 1.
- Results publication: PubMed 30201580Shi L, Chen Y, Miao J, Shi J, Chen D. Reduction of Slippage Influences Surgical Outcomes of Grade II and III Lumbar Isthmic Spondylolisthesis. World Neurosurg. 2018 Dec;120:e1017-e1023. doi: 10.1016/j.wneu.2018.08.217. Epub 2018 Sep 7.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PI-LL in people with Isthmic Spondylolisthesis, run by Peking University Third Hospital 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 1 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: finished, as of the sponsor's last update on 20 Jul 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PI (time frame: through study completion, an average of 1 year). The study lists 5 primary outcomes in all. 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 NCT04968626, which also lists 10 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 20 Jul 2021.