Degenerative Lumbar Spinal StenosisNCT04467944
Effect of Pre-existing Adjacent Segment Degeneration on Long-term Effectiveness After Lumbar Fusion Surgery
An observational study of Degenerative Lumbar Spinal Stenosis and Degenerative Disc Disease, run by Peking University Third Hospital at 1 site in China.
Trial summary
This is a prospective single-center study. Patients requiring posterior lumbar interbody fusion (PLIF) for lumbar degenerative disease are prospectively enrolled and followed. Important adjacent pre-existing degeneration factors include discs degenerated, facets and ligamentum flavum tropism which could lead to spinal… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Degenerative Lumbar Spinal Stenosis, Degenerative Disc Disease, Degeneration Spine
- What is being tested?
- Pre-existing degenerative factors at adjacent segment
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Dec 2032
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In the orthopaedic department of Peking University Third Hospital, patients with a clear diagnosis of lumbar degenerative disease, and surgical level of L4-S1 will be enrolled.
Who may be able to join
- A clear diagnosis of lumbar spinal stenosis, and surgical level of L4- S1 (The levels to be operated on were decided by matching the clinical symptomatology with the radiological findings of the spinal levels that needed decompression);
- Failed at least eight weeks conservative treatment;
Who cannot join
- Unstable factors (slip, rotation, lateral bending, etc.) in adjacent segment L3/4;
- Preoperative sagittal and coronal imbalance of the spine;
- Lumbar infection and/or tumor diseases;
- A previous history of lumbar fusion surgery.
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, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Da Zou, M.D., zd_puth@163.com
About this study
Official title: Effect of Pre-existing Adjacent Segment Degeneration on Long-term Effectiveness After Lumbar Fusion Surgery: a Prospective Cohort Study
This is a prospective single-center study. Patients requiring posterior lumbar interbody fusion (PLIF) for lumbar degenerative disease are prospectively enrolled and followed. Important adjacent pre-existing degeneration factors include discs degenerated, facets and ligamentum flavum tropism which could lead to spinal canal stenosis (SCS). This study will focus on the effects of pre- existing adjacent degeneration (disc factors and spinal canal stenosis factors) on long-term postoperative outcomes.
Read the detailed description
Adjacent segment pathologies (ASP), including radiological adjacent segment degeneration (ASDeg) and adjacent segment disease (ASDis) after lumbar fusion surgeries have been troubling complications. The development of ASDis greatly reduces postoperative quality of life, and revision surgery may be required in severe cases. Several risk factors for ASP have been reported, such as age, sex, pre-existing adjacent degeneration, multilevel fusions, sagittal imbalance, the type of fusion, facet tropism and laminar inclination. Because multi-level degenerative imaging is common in lumbar degenerative disease, pre-existing adjacent degeneration makes challenge for the surgery strategy, sometimes it is difficult to determine the level at which fusion ends. Important pre-existing adjacent degeneration factors included discs degenerated, facets and ligamentum flavum tropism which could lead to spinal canal stenosis (SCS). Few studies have focused on asymptomatic pre-existing SCS as a risk factor for ASDis that requires additional surgery at an adjacent segment. But these studies only used the sagittal diameter or ratio to evaluate the degree of adjacent SCS. The status of neural tissues in the canal was neglected. Few studies also have focused on asymptomatic pre-existing degenerated disc as a risk factor for ASDeg. But these studies only used Pfirrmann grade to evaluate the degenerated disc. High-intensity zone (Hiz), vacuum sign were neglected.
This prospective study was limited to patients with the same preoperative pathology, the same fusion segments (L4-5 and L5-S1), the same fusion technique (PLIF). Dynamic X-ray and MRI examinations of lumbar will be completed to evaluate the imaging manifestations of the responsible and adjacent segments before surgery. The T2-weighted sagittal and axial MRI images are studied and the following parameters are recorded: grade of cerebrospinal fluid occlusion in L3/4 spinal canal at disc level, and the narrowest axial plane was used for grading; L3/4 disc degeneration by Pfirrmann grade; high-intensity zone (Hiz) and vacuum sign of L3/4 disc; L3/4 disc herniation quantificationally measured by MSU Classification; Patients will be divided into three groups according to the pre-existing status of L3/4 segment. Patients without pre-existing degeneration at L3/4 segment will be classified into control group (NS group). Patients with pre-existing disc factors (Pfirrmann grade≥3, Hiz or vacuum sign) at L3/4 segment will be classified into group D. Patients with pre-existing canal stenosis factors (cerebrospinal fluid occlusion≥1) at L3/4 segment will be classified into group C.
The patient's age, gender, preoperative body mass index (BMI), American Society of Anesthesiologists classification of anesthesia (ASA grade) will be recorded during the hospital stay. Surgical data including operation time, blood loss, perioperative complications (including cerebrospinal fluid leakage, wound infection, postoperative neurological dysfunction, and perioperative secondary surgery, cardiopulmonary complication, cerebral infarction/hemorrhage, etc.), and length of hospital stay are also recorded. Preoperative clinical function questionnaires, including visual analog scale (VAS) of low back, VAS of the legs, and Oswestry Disability Index (ODI) scores for patients were completed on admission for surgery without any assistance. All the patients enrolled will finished the follow-up from date of surgery at 1,2 and 5 years. The clinical outcomes and ASP will be recorded.
- Being tested
- Pre-existing degenerative factors at adjacent segment
- Keywords
- Cerebrospinal fluid occlusion, Pre-existing degeneration, Spinal canal stenosis, Adjacent segment degeneration, Adjacent segment disease, High-intensity zone, Vacuum sign
- Medical subject headings
- Intervertebral Disc Degeneration, Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-existing degenerative factors at adjacent segmentOther
Pre-existing degenerative factors at adjacent segment, including disc factors and canal stenosis factors
| Study group | Role | What they receive |
|---|---|---|
| NS Group | Patients without pre-existing degeneration at L3/4 segment will be classified into control group (NS group). | |
| D Group | Patients with pre-existing disc factors (Pfirrmann grade≥3, Hiz or vacuum sign) at L3/4 segment will be classified into group D. Receives: Other: Pre-existing degenerative factors at adjacent segment | |
| C Group | Patients with pre-existing canal stenosis factors (cerebrospinal fluid occlusion≥1) at L3/4 segment will be classified into group C. Receives: Other: Pre-existing degenerative factors at adjacent segment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adjacent segment degeneration (ASDeg)
ASDeg is defined as follows according to manifestations on X-rays and MRI changing from baseline : (1) Progression ≥1 grade in SCS or L3/4 disc degeneration; (2)Alteration of L3/4 disc herniation, Hiz and vacuum sign; (3) Progression of ≥ 3 mm in vertebral slippage, a change of ≥ 10° in the intervertebral angle on flexion and extension lateral radiograph, or scoliosis deformity on coronal plane.
Measured: 12 months after surgery
Adjacent segment degeneration (ASDeg)
ASDeg is defined as follows according to manifestations on X-rays and MRI changing from baseline : (1) Progression ≥1 grade in SCS or L3/4 disc degeneration; (2)Alteration of L3/4 disc herniation, Hiz and vacuum sign; (3) Progression of ≥ 3 mm in vertebral slippage, a change of ≥ 10° in the intervertebral angle on flexion and extension lateral radiograph, or scoliosis deformity on coronal plane.
Measured: 24 months after surgery
Adjacent segment degeneration (ASDeg)
ASDeg is defined as follows according to manifestations on X-rays and MRI changing from baseline : (1) Progression ≥1 grade in SCS or L3/4 disc degeneration; (2)Alteration of L3/4 disc herniation, Hiz and vacuum sign; (3) Progression of ≥ 3 mm in vertebral slippage, a change of ≥ 10° in the intervertebral angle on flexion and extension lateral radiograph, or scoliosis deformity on coronal plane.
Measured: 60 months after surgery
Adjacent segment degeneration (ASDeg)
ASDeg is defined as follows according to manifestations on X-rays and MRI changing from baseline : (1) Progression ≥1 grade in SCS or L3/4 disc degeneration; (2)Alteration of L3/4 disc herniation, Hiz and vacuum sign; (3) Progression of ≥ 3 mm in vertebral slippage, a change of ≥ 10° in the intervertebral angle on flexion and extension lateral radiograph, or scoliosis deformity on coronal plane.
Measured: 120 months after surgery
Adjacent segment disease (ASDis)
ASDis is defined as clinical and radiographic evidence of degenerative spinal disease (disc degeneration, stenosis, or spondylolisthesis) on the level adjacent to the index fusion.
Measured: The entire study process, up to 120 months after surgery.
Secondary outcomes (3)
Disability
The Oswestry Disability Index (ODI) (0-100) is used to assess disability.
Measured: 12 months after surgery; 24 months after surgery; 60 months after surgery; 120 months after surgery.
Back pain
The Visual Analog Scale (0-10) is used to evaluate back pain.
Measured: 12 months after surgery; 24 months after surgery; 60 months after surgery; 120 months after surgery.
Leg pain
The Visual Analog Scale (0-10) is used to evaluate leg pain.
Measured: 12 months after surgery; 24 months after surgery; 60 months after surgery; 120 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start1 Jan 2018
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Degenerative Lumbar Spinal StenosisStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei Shi Li, Dr., Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467944
- Sponsor's protocol ID
- M2017399
- Status last verified
- Jun 2020
- First submitted
- 28 Jun 2020
- Last updated
- 13 Jul 2020
- 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 for half a year after the publication of the results of the study.
Publications
Lee JC, Kim Y, Soh JW, Shin BJ. Risk factors of adjacent segment disease requiring surgery after lumbar spinal fusion: comparison of posterior lumbar interbody fusion and posterolateral fusion. Spine (Phila Pa 1976). 2014 Mar 1;39(5):E339-45. doi: 10.1097/BRS.0000000000000164.
PubMed 24365899Lawrence BD, Wang J, Arnold PM, Hermsmeyer J, Norvell DC, Brodke DS. Predicting the risk of adjacent segment pathology after lumbar fusion: a systematic review. Spine (Phila Pa 1976). 2012 Oct 15;37(22 Suppl):S123-32. doi: 10.1097/BRS.0b013e31826d60d8.
PubMed 22885827Yugue I, Okada S, Masuda M, Ueta T, Maeda T, Shiba K. Risk factors for adjacent segment pathology requiring additional surgery after single-level spinal fusion: impact of pre-existing spinal stenosis demonstrated by preoperative myelography. Eur Spine J. 2016 May;25(5):1542-1549. doi: 10.1007/s00586-015-4185-6. Epub 2015 Aug 14.
PubMed 26272373Lee GY, Lee JW, Choi HS, Oh KJ, Kang HS. A new grading system of lumbar central canal stenosis on MRI: an easy and reliable method. Skeletal Radiol. 2011 Aug;40(8):1033-9. doi: 10.1007/s00256-011-1102-x. Epub 2011 Feb 1.
PubMed 21286714Mysliwiec LW, Cholewicki J, Winkelpleck MD, Eis GP. MSU classification for herniated lumbar discs on MRI: toward developing objective criteria for surgical selection. Eur Spine J. 2010 Jul;19(7):1087-93. doi: 10.1007/s00586-009-1274-4. Epub 2010 Jan 19.
PubMed 20084410Nakashima H, Kawakami N, Tsuji T, Ohara T, Suzuki Y, Saito T, Nohara A, Tauchi R, Ohta K, Hamajima N, Imagama S. Adjacent Segment Disease After Posterior Lumbar Interbody Fusion: Based on Cases With a Minimum of 10 Years of Follow-up. Spine (Phila Pa 1976). 2015 Jul 15;40(14):E831-41. doi: 10.1097/BRS.0000000000000917.
PubMed 25839385
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pre-existing Adjacent Segment Degeneration on Long-term Effectiveness After Lumbar Fusion Surgery: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04467944
- Acronym / sponsor ID
- M2017399
- Keywords
- Cerebrospinal fluid occlusion, Pre-existing degeneration, Spinal canal stenosis, Adjacent segment degeneration, Adjacent segment disease, High-intensity zone, Vacuum sign
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 13 Jul 2020 (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 prospective single-center study. Patients requiring posterior lumbar interbody fusion (PLIF) for lumbar degenerative disease are prospectively enrolled and followed. Important adjacent pre-existing degeneration factors include discs degenerated, facets and ligamentum flavum tropism which could lead to spinal canal stenosis (SCS). This study will focus on the effects of pre- existing adjacent degeneration (disc factors and spinal canal stenosis factors) on long-term postoperative outcomes.
Detailed description
Adjacent segment pathologies (ASP), including radiological adjacent segment degeneration (ASDeg) and adjacent segment disease (ASDis) after lumbar fusion surgeries have been troubling complications. The development of ASDis greatly reduces postoperative quality of life, and revision surgery may be required in severe cases. Several risk factors for ASP have been reported, such as age, sex, pre-existing adjacent degeneration, multilevel fusions, sagittal imbalance, the type of fusion, facet tropism and laminar inclination. Because multi-level degenerative imaging is common in lumbar degenerative disease, pre-existing adjacent degeneration makes challenge for the surgery strategy, sometimes it is difficult to determine the level at which fusion ends. Important pre-existing adjacent degeneration factors included discs degenerated, facets and ligamentum flavum tropism which could lead to spinal canal stenosis (SCS). Few studies have focused on asymptomatic pre-existing SCS as a risk factor for ASDis that requires additional surgery at an adjacent segment. But these studies only used the sagittal diameter or ratio to evaluate the degree of adjacent SCS. The status of neural tissues in the canal was neglected. Few studies also have focused on asymptomatic pre-existing degenerated disc as a risk factor for ASDeg. But these studies only used Pfirrmann grade to evaluate the degenerated disc. High-intensity zone (Hiz), vacuum sign were neglected.
This prospective study was limited to patients with the same preoperative pathology, the same fusion segments (L4-5 and L5-S1), the same fusion technique (PLIF). Dynamic X-ray and MRI examinations of lumbar will be completed to evaluate the imaging manifestations of the responsible and adjacent segments before surgery. The T2-weighted sagittal and axial MRI images are studied and the following parameters are recorded: grade of cerebrospinal fluid occlusion in L3/4 spinal canal at disc level, and the narrowest axial plane was used for grading; L3/4 disc degeneration by Pfirrmann grade; high-intensity zone (Hiz) and vacuum sign of L3/4 disc; L3/4 disc herniation quantificationally measured by MSU Classification; Patients will be divided into three groups according to the pre-existing status of L3/4 segment. Patients without pre-existing degeneration at L3/4 segment will be classified into control group (NS group). Patients with pre-existing disc factors (Pfirrmann grade≥3, Hiz or vacuum sign) at L3/4 segment will be classified into group D. Patients with pre-existing canal stenosis factors (cerebrospinal fluid occlusion≥1) at L3/4 segment will be classified into group C.
The patient's age, gender, preoperative body mass index (BMI), American Society of Anesthesiologists classification of anesthesia (ASA grade) will be recorded during the hospital stay. Surgical data including operation time, blood loss, perioperative complications (including cerebrospinal fluid leakage, wound infection, postoperative neurological dysfunction, and perioperative secondary surgery, cardiopulmonary complication, cerebral infarction/hemorrhage, etc.), and length of hospital stay are also recorded. Preoperative clinical function questionnaires, including visual analog scale (VAS) of low back, VAS of the legs, and Oswestry Disability Index (ODI) scores for patients were completed on admission for surgery without any assistance. All the patients enrolled will finished the follow-up from date of surgery at 1,2 and 5 years. The clinical outcomes and ASP will be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NS Group | – | –Patients without pre-existing degeneration at L3/4 segment will be classified into control group (NS group). |
| D Group | – | Other: Pre-existing degenerative factors at adjacent segmentPatients with pre-existing disc factors (Pfirrmann grade≥3, Hiz or vacuum sign) at L3/4 segment will be classified into group D. |
| C Group | – | Other: Pre-existing degenerative factors at adjacent segmentPatients with pre-existing canal stenosis factors (cerebrospinal fluid occlusion≥1) at L3/4 segment will be classified into group C. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In the orthopaedic department of Peking University Third Hospital, patients with a clear diagnosis of lumbar degenerative disease, and surgical level of L4-S1 will be enrolled.
Key inclusion criteria (2 listed)
- A clear diagnosis of lumbar spinal stenosis, and surgical level of L4- S1 (The levels to be operated on were decided by matching the clinical symptomatology with the radiological findings of the spinal levels that needed decompression);
- Failed at least eight weeks conservative treatment;
Key exclusion criteria (4 listed)
- Unstable factors (slip, rotation, lateral bending, etc.) in adjacent segment L3/4;
- Preoperative sagittal and coronal imbalance of the spine;
- 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 |
|---|---|---|
| Pre-existing degenerative factors at adjacent segmentPre-existing degenerative factors at adjacent segment, including disc factors and canal stenosis factors | Other | C Group, D Group |
Primary outcome
Adjacent segment degeneration (ASDeg)
Time frame: 12 months after surgery
ASDeg is defined as follows according to manifestations on X-rays and MRI changing from baseline : (1) Progression ≥1 grade in SCS or L3/4 disc degeneration; (2)Alteration of L3/4 disc herniation, Hiz and vacuum sign; (3) Progression of ≥ 3 mm in vertebral slippage, a change of ≥ 10° in the intervertebral angle on flexion and extension lateral radiograph, or scoliosis deformity on coronal plane.
Adjacent segment degeneration (ASDeg)
Time frame: 24 months after surgery
ASDeg is defined as follows according to manifestations on X-rays and MRI changing from baseline : (1) Progression ≥1 grade in SCS or L3/4 disc degeneration; (2)Alteration of L3/4 disc herniation, Hiz and vacuum sign; (3) Progression of ≥ 3 mm in vertebral slippage, a change of ≥ 10° in the intervertebral angle on flexion and extension lateral radiograph, or scoliosis deformity on coronal plane.
Adjacent segment degeneration (ASDeg)
Time frame: 60 months after surgery
ASDeg is defined as follows according to manifestations on X-rays and MRI changing from baseline : (1) Progression ≥1 grade in SCS or L3/4 disc degeneration; (2)Alteration of L3/4 disc herniation, Hiz and vacuum sign; (3) Progression of ≥ 3 mm in vertebral slippage, a change of ≥ 10° in the intervertebral angle on flexion and extension lateral radiograph, or scoliosis deformity on coronal plane.
Adjacent segment degeneration (ASDeg)
Time frame: 120 months after surgery
ASDeg is defined as follows according to manifestations on X-rays and MRI changing from baseline : (1) Progression ≥1 grade in SCS or L3/4 disc degeneration; (2)Alteration of L3/4 disc herniation, Hiz and vacuum sign; (3) Progression of ≥ 3 mm in vertebral slippage, a change of ≥ 10° in the intervertebral angle on flexion and extension lateral radiograph, or scoliosis deformity on coronal plane.
Adjacent segment disease (ASDis)
Time frame: The entire study process, up to 120 months after surgery.
ASDis is defined as clinical and radiographic evidence of degenerative spinal disease (disc degeneration, stenosis, or spondylolisthesis) on the level adjacent to the index fusion.
3 secondary outcomes
Disability
Time frame: 12 months after surgery; 24 months after surgery; 60 months after surgery; 120 months after surgery.
Back pain
Time frame: 12 months after surgery; 24 months after surgery; 60 months after surgery; 120 months after surgery.
Leg pain
Time frame: 12 months after surgery; 24 months after surgery; 60 months after surgery; 120 months 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 13 Jul 2020.
- Results publication: PubMed 24365899Lee JC, Kim Y, Soh JW, Shin BJ. Risk factors of adjacent segment disease requiring surgery after lumbar spinal fusion: comparison of posterior lumbar interbody fusion and posterolateral fusion. Spine (Phila Pa 1976). 2014 Mar 1;39(5):E339-45. doi: 10.1097/BRS.0000000000000164.
- Results publication: PubMed 22885827Lawrence BD, Wang J, Arnold PM, Hermsmeyer J, Norvell DC, Brodke DS. Predicting the risk of adjacent segment pathology after lumbar fusion: a systematic review. Spine (Phila Pa 1976). 2012 Oct 15;37(22 Suppl):S123-32. doi: 10.1097/BRS.0b013e31826d60d8.
- Results publication: PubMed 26272373Yugue I, Okada S, Masuda M, Ueta T, Maeda T, Shiba K. Risk factors for adjacent segment pathology requiring additional surgery after single-level spinal fusion: impact of pre-existing spinal stenosis demonstrated by preoperative myelography. Eur Spine J. 2016 May;25(5):1542-1549. doi: 10.1007/s00586-015-4185-6. Epub 2015 Aug 14.
- Results publication: PubMed 21286714Lee GY, Lee JW, Choi HS, Oh KJ, Kang HS. A new grading system of lumbar central canal stenosis on MRI: an easy and reliable method. Skeletal Radiol. 2011 Aug;40(8):1033-9. doi: 10.1007/s00256-011-1102-x. Epub 2011 Feb 1.
- Results publication: PubMed 20084410Mysliwiec LW, Cholewicki J, Winkelpleck MD, Eis GP. MSU classification for herniated lumbar discs on MRI: toward developing objective criteria for surgical selection. Eur Spine J. 2010 Jul;19(7):1087-93. doi: 10.1007/s00586-009-1274-4. Epub 2010 Jan 19.
- Results publication: PubMed 25839385Nakashima H, Kawakami N, Tsuji T, Ohara T, Suzuki Y, Saito T, Nohara A, Tauchi R, Ohta K, Hamajima N, Imagama S. Adjacent Segment Disease After Posterior Lumbar Interbody Fusion: Based on Cases With a Minimum of 10 Years of Follow-up. Spine (Phila Pa 1976). 2015 Jul 15;40(14):E831-41. doi: 10.1097/BRS.0000000000000917.
- Individual participant dataSharing planned: Yes. We will make the clinical study report available for 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.
Wei Shi Li, Dr. principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Lumbar Spinal Stenosis and Degenerative Disc Disease, 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 2 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: looking for participants now, as of the sponsor's last update on 13 Jul 2020. 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 Zhuo Ran Sun, Dr. (+8618610292513, puh3_szr@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adjacent segment degeneration (ASDeg) (time frame: 12 months after surgery). 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 NCT04467944, which also lists 6 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 13 Jul 2020.