Degenerative ScoliosisNCT04071665
A Modified Lateral Lumbar Interbody Fusion VS. Transforaminal Lumbar Interbody Fusion for Adult Degenerative Scoliosis
A study testing Modified lateral lumbar interbody fusion in people with Degenerative Scoliosis and Minimally Invasive, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
A modified lateral lumbar interbody fusion VS. transforaminal lumbar interbody fusion for the treatment of adult degenerative scoliosis with 2 year follow-up with a multiple center, randomized case-control study Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Degenerative Scoliosis, Minimally Invasive, Spinal Deformity
- What is being tested?
- Modified lateral lumbar interbody fusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2020to 31 Dec 2022
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 50 years of age, diagnosed with adult thoracolumbar scoliosis including any number of intervertebral levels between T8 and S1, unresponsive to conservative treatment for at least 6 months, and had a preoperative coronal Cobb angle of at least 10° and preoperative ODI score of at least 30%.
Who cannot join
- with prior lumbar fusion surgery or spondylolisthesis greater than Grade II
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital, School of Medicine, Zejiang University
Hangzhou, Zhejiang, 310000
Zhiwei Wang, PhD
About this study
A modified lateral lumbar interbody fusion VS. transforaminal lumbar interbody fusion for the treatment of adult degenerative scoliosis with 2 year follow-up with a multiple center, randomized case-control study
Read the detailed description
Adult degenerative scoliosis (ADS) is the most common spinal deformity in the elderly, and the severe patients need surgical treatment. The elderly are often complicated with many medical diseases and the perioperative risk is high, so minimally invasive surgery is a new choice for spinal surgeons to treat ADS. Modified lateral lumbar interbody fusion (CLIF) is an new modified spinal minimally invasive interbody fusion technique in the investigator's department. The results of preliminary studies showed that it has the advantages of less trauma, short operation time and fewer complications, and the clinical and imaging outcome are remarkable. Therefore, the present study aims to establish a multicenter, large sample prospective randomized controlled study to explore the technical advantages and surgical indications of the new technique in the treatment of ADS by comparing with the traditional posterior spinal interbody fusion; (2) to compare the postoperative clinical and imaging results and analyze the surgical complications and preventive measures; (3) to establish a long-term follow-up to further quantify the clinical and imaging outcome of the new technique. Therefore, this study will further verify the safety and effectiveness of the CLIF in the treatment of ADS on the basis of previous studies, and provide a new clinical approach for minimally invasive treatment of ADS.
- Conditions
- Degenerative Scoliosis, Minimally Invasive, Spinal Deformity
- Being tested
- Modified lateral lumbar interbody fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified lateral lumbar interbody fusionProcedure or surgery
Modified lateral lumbar interbody fusion
| Study group | Role | What they receive |
|---|---|---|
| Modified lateral lumbar interbody fusion | Experimental | Modified lateral lumbar interbody fusion for treatment of scoliosis Receives: Procedure: Modified lateral lumbar interbody fusion |
| transforaminal lumbar interbody fusion | Active comparator | transforaminal lumbar interbody fusion Receives: Procedure: Modified lateral lumbar interbody fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
ODI score
an index for assessing the lower back pain wiith multiple questionnare
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 May 2020 (estimated)
- Primary completion1 Jan 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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 Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, First Affiliated Hospital of Shantou University Medical College, Shenzhen University
- Responsible party
- Sponsor
- Investigators
- Qixin CHEN, Ph.D, Study director, Orthopedics Department, 2nd Hospital, School of Medicine, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04071665
- Sponsor's protocol ID
- NSFC 81702220
- Status last verified
- Jun 2019
- First submitted
- 26 Aug 2019
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: after complete the recruiment with half of participants, we will share the preliminary results with data.
Publications
Mendoza-Lattes S. Cervical Disc Replacement: Are We There Yet? Commentary on an article by Michael E. Janssen, DO, et al.: "ProDisc-C Total Disc Replacement Versus Anterior Cervical Discectomy and Fusion for Single-Level Symptomatic Cervical Disc Disease. Seven-Year Follow-up of the Prospective Randomized U.S. Food and Drug Administration Investigational Device Exemption Study". J Bone Joint Surg Am. 2015 Nov 4;97(21):e71. doi: 10.2106/JBJS.O.00750. No abstract available.
PubMed 26537171Kretzer RM. Adult Degenerative Spinal Deformity: Overview and Open Approaches for Treatment. Spine (Phila Pa 1976). 2017 Apr 1;42 Suppl 7:S16. doi: 10.1097/BRS.0000000000002028. No abstract available.
PubMed 28296697Bach K, Ahmadian A, Deukmedjian A, Uribe JS. Minimally invasive surgical techniques in adult degenerative spinal deformity: a systematic review. Clin Orthop Relat Res. 2014 Jun;472(6):1749-61. doi: 10.1007/s11999-013-3441-5.
PubMed 24488750Epstein NE. Commentary on: Laminectomy plus fusion versus laminectomy alone for lumbar spondylolisthesis by Ghogawala Z, Dziura J, Butler WE, Dai F, Terrin N, Magge SN, et al. NEJM 2016;374 (15):1424-34. Surg Neurol Int. 2016 Sep 22;7(Suppl 25):S644-S647. doi: 10.4103/2152-7806.191061. eCollection 2016.
PubMed 27843677Epstein NE. Commentary on: A randomized controlled trial of fusion surgery for lumbar spinal stenosis (Forsth P, Olafsson G, Carlsson T, Frost A, Borgstrom F, Fritzell P, et al. N Eng J Med 2016;374:1414-23). Surg Neurol Int. 2016 Sep 22;7(Suppl 25):S641-S643. doi: 10.4103/2152-7806.191060. eCollection 2016.
PubMed 27843676
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Modified Lateral Lumbar Interbody Fusion VS. Transforaminal Lumbar Interbody Fusion for Adult Degenerative Scoliosis
- ClinicalTrials.gov ID
- NCT04071665
- Acronym / sponsor ID
- NSFC 81702220
- Conditions
- Degenerative Scoliosis, Minimally Invasive, Spinal Deformity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, First Affiliated Hospital of Shantou University Medical College, Shenzhen University
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 28 Aug 2019 (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.
A modified lateral lumbar interbody fusion VS. transforaminal lumbar interbody fusion for the treatment of adult degenerative scoliosis with 2 year follow-up with a multiple center, randomized case-control study
Detailed description
Adult degenerative scoliosis (ADS) is the most common spinal deformity in the elderly, and the severe patients need surgical treatment. The elderly are often complicated with many medical diseases and the perioperative risk is high, so minimally invasive surgery is a new choice for spinal surgeons to treat ADS. Modified lateral lumbar interbody fusion (CLIF) is an new modified spinal minimally invasive interbody fusion technique in the investigator's department. The results of preliminary studies showed that it has the advantages of less trauma, short operation time and fewer complications, and the clinical and imaging outcome are remarkable. Therefore, the present study aims to establish a multicenter, large sample prospective randomized controlled study to explore the technical advantages and surgical indications of the new technique in the treatment of ADS by comparing with the traditional posterior spinal interbody fusion; (2) to compare the postoperative clinical and imaging results and analyze the surgical complications and preventive measures; (3) to establish a long-term follow-up to further quantify the clinical and imaging outcome of the new technique. Therefore, this study will further verify the safety and effectiveness of the CLIF in the treatment of ADS on the basis of previous studies, and provide a new clinical approach for minimally invasive treatment of ADS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified lateral lumbar interbody fusion | Experimental | Procedure: Modified lateral lumbar interbody fusionModified lateral lumbar interbody fusion for treatment of scoliosis |
| transforaminal lumbar interbody fusion | Active comparator | Procedure: Modified lateral lumbar interbody fusiontransforaminal lumbar interbody fusion |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- at least 50 years of age, diagnosed with adult thoracolumbar scoliosis including any number of intervertebral levels between T8 and S1, unresponsive to conservative treatment for at least 6 months, and had a preoperative coronal Cobb angle of at least 10° and preoperative ODI score of at least 30%.
Key exclusion criteria (1 listed)
- with prior lumbar fusion surgery or spondylolisthesis greater than Grade II
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 |
|---|---|---|
| Modified lateral lumbar interbody fusionModified lateral lumbar interbody fusion | Procedure or surgery | Modified lateral lumbar interbody fusion, transforaminal lumbar interbody fusion |
Primary outcome
ODI score
Time frame: 2 years
an index for assessing the lower back pain wiith multiple questionnare
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Background: PubMed 26537171Mendoza-Lattes S. Cervical Disc Replacement: Are We There Yet? Commentary on an article by Michael E. Janssen, DO, et al.: "ProDisc-C Total Disc Replacement Versus Anterior Cervical Discectomy and Fusion for Single-Level Symptomatic Cervical Disc Disease. Seven-Year Follow-up of the Prospective Randomized U.S. Food and Drug Administration Investigational Device Exemption Study". J Bone Joint Surg Am. 2015 Nov 4;97(21):e71. doi: 10.2106/JBJS.O.00750. No abstract available.
- Background: PubMed 28296697Kretzer RM. Adult Degenerative Spinal Deformity: Overview and Open Approaches for Treatment. Spine (Phila Pa 1976). 2017 Apr 1;42 Suppl 7:S16. doi: 10.1097/BRS.0000000000002028. No abstract available.
- Background: PubMed 24488750Bach K, Ahmadian A, Deukmedjian A, Uribe JS. Minimally invasive surgical techniques in adult degenerative spinal deformity: a systematic review. Clin Orthop Relat Res. 2014 Jun;472(6):1749-61. doi: 10.1007/s11999-013-3441-5.
- Results publication: PubMed 27843677Epstein NE. Commentary on: Laminectomy plus fusion versus laminectomy alone for lumbar spondylolisthesis by Ghogawala Z, Dziura J, Butler WE, Dai F, Terrin N, Magge SN, et al. NEJM 2016;374 (15):1424-34. Surg Neurol Int. 2016 Sep 22;7(Suppl 25):S644-S647. doi: 10.4103/2152-7806.191061. eCollection 2016.
- Results publication: PubMed 27843676Epstein NE. Commentary on: A randomized controlled trial of fusion surgery for lumbar spinal stenosis (Forsth P, Olafsson G, Carlsson T, Frost A, Borgstrom F, Fritzell P, et al. N Eng J Med 2016;374:1414-23). Surg Neurol Int. 2016 Sep 22;7(Suppl 25):S641-S643. doi: 10.4103/2152-7806.191060. eCollection 2016.
- Individual participant dataSharing planned: No. after complete the recruiment with half of participants, we will share the preliminary results with data.
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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.
Qixin CHEN, Ph.D study director
Orthopedics Department, 2nd Hospital, School of Medicine, Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified lateral lumbar interbody fusion in people with Degenerative Scoliosis and Minimally Invasive, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 1 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 12 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fangcai LI, Ph.D (86-057187784594, 89048991@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ODI score (time frame: 2 years). 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 NCT04071665, which also lists 5 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 12 May 2020.