Comparing two surgical techniques for treating severe narrowing of the lower spine
ISRCTN | ISRCTN73844142 |
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DOI | https://doi.org/10.1186/ISRCTN73844142 |
- Submission date
- 06/06/2024
- Registration date
- 05/11/2024
- Last edited
- 04/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Over the past few decades, fusion surgery has become the preferred treatment for lumbar degenerative diseases, which involve the wearing down of the lower spine, causing pain and other issues. This type of surgery has generally yielded good results. Lumbar spinal stenosis (LSS), a condition where the spaces in the lower spine become narrow and put pressure on the nerves, is common in middle-aged and older adults and has been a focus of research for about 50 years. Surgery is often necessary for patients who do not respond to other treatments or who have serious nerve problems. Traditional surgical approaches, such as Anterior Lumbar Interbody Fusion (ALIF) and Posterior Lumbar Interbody Fusion (PLIF/TLIF), have shown good long-term outcomes but can have complications, including blood vessel injury and retrograde ejaculation in ALIF, and increased spinal instability and nerve damage in PLIF/TLIF. To mitigate these issues, some surgeons advocate for minimally invasive approaches like Extreme Lateral Interbody Fusion (XLIF) and Oblique Lumbar Interbody Fusion (OLIF), with OLIF being favored for avoiding major blood vessels and nerves. However, most data on OLIF come from mild to moderate LSS cases, with limited information on its effectiveness for severe LSS, a condition that is increasingly common in older adults. This study aims to compare OLIF with the traditional TLIF technique for treating severe LSS, assessing clinical and radiological outcomes to determine if OLIF is a feasible, effective, and safe option, thereby providing a minimally invasive surgical alternative for both surgeons and patients.
Who can participate?
Lumbar spinal stenosis patients aged 18 - 80 years requiring operation.
What does the study involve?
Participants will be randomly allocated to OLIF or TLIF group as part of their lumbar decompression and fusion surgery. Follow-up will be for 24 months.
What are the possible benefits and risks of participating?
The patients will gain added benefits such as the close monitoring by the treating physician before and for 2 years after the surgery, as well as the opportunity to discuss the problems they are facing and find solutions with their physician. The patients will have no added risks associated with the current study.
Where is the study run from?
The first affiliated Hospital of Soochow University (China)
When is the study starting and how long is it expected to run for?
September 2018 to September 2021
Who is funding the study?
This study has been supported by the Natural Science Foundation of Jiangsu Province (BK20130274), Research on collaborative innovation of medical and industrial integration in Suzhou (SZM2023010), Suzhou Medical Health Science and Technology Innovation Key Technology (SKY2021027) (China)
Who is the main contact?
Dr Xuefeng Li ,lixuefeng@suda.edu.cn
Contact information
Public, Scientific, Principal Investigator
899 Pinghai Road
Suzhou
215006
China
0000-0002-9319-614X | |
Phone | +86 51267972285 |
lixuefeng@suda.edu.cn |
Public, Scientific, Principal Investigator
899 Pinghai Road
suzhou
215006
China
Phone | +86 51267972285 |
---|---|
liuyijie@suda.edu.cn |
Public, Scientific, Principal Investigator
899 Pinghai Road
Suzhou
215006
China
Phone | +86 51267972285 |
---|---|
chugenglei@suda.edu.cn |
Study information
Study design | Multicenter interventional prospective randomized study |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet. Send an email to lixuefeng@suda.edu.cn or communicate via phone at +86051267972285 |
Scientific title | A multi-center, prospective, randomized, comparative study comparing Oblique lumbar interbody fusion (OLIF) supplemented with lateral vertebral screw fixation versus transforaminal lumbar interbody fusion (TLIF) for the treatment of severe lumbar spinal stenosis (Schizas C, D type) |
Study objectives | OLIF supplemented with lateral vertebral screw fixation can ahieve sastisfactory outcomes comparable to TLIF for severe spinal stenosis patients, whereas with less invasiveness and more quicker recovery. |
Ethics approval(s) |
Approved 20/09/2018, The Ethics Committee of The First Affiliated Hospital of Soochow University (899 pinghai Road, Suzhou, 215006, China; +86 51267972285; lixuefeng@suda.edu.cn), ref: ref:165 |
Health condition(s) or problem(s) studied | Surgical treatment of patients with severe lumbar canal stenosis |
Intervention | The total duration of treatment and follow-up for all study arms: from November 2018 to September 2021,a total of 224 LSS patients rated as Schizas C、D grade meeting above criteria were enrolled in this study following institutional review board approval and they were allocated randomly into two groups (OLIF or TLIF). The follow-up period was expected to be a minimum of 2 yrs. A summary of the treatment given to each group: OLIF group: the patient was placed into a right-sided lateral decubitus position under general anesthesia, a transverse skin incision of 3-5 centimeter centered over the anterior one-third of target space was made in the lateral abdominal region, the external oblique fascia was incised using monopolar cautery, and the abdominal muscle and transversalis fascia are divided bluntly.Once in the retroperitoneal space, blunt dissection was used to mobilize the peritoneum anteriorly and psoas posteriorly. Under direct visualization,serial dilators and tubular retractor were placed after the confirmation of the target level by C-arm followed by our special “egg-shell”discectomy and implantation of proper size Cage (Oracle Spinal System: DePuy-Synthes Spine, Raynham, Massachusetts, USA) filled with allograft bone. Then, additional fixation by lateral vertebral screw-rod system was done and after final radiographic confirmation, surgical site was rinsed by sterile saline and closed. TLIF group:the patient was placed in prone position,Under general anesthesia,after routine longitudinal skin incision and para-median stripping of spinal muscle, lamina and facet joint was exposed on the symptomatic side and a Wiltse approach was adopted on the contralateral side to expose facet joint only. After routine pedicle screw implantation, unilateral laminectomy and facetectomy was performed on the symptomatic side to expose disc space, followed by discectomy and end-plate preparation, implantation of an amount of autogenous morselized bone and a polyetheretherketone (PEEK) cage of appropriate size filled with autogenous morselized bone, two rods of proper length was then applied and fastened.after final radiographic confirmation,surgical site was rinsed and closed, with the placement of drain depending on local oozing. After surgery, all patients were given antibiotic and painkiller therapy in accordance with guideline recommendations and encouraged to take ambulation with help of brace on the first postoperative day. Details of the randomisation process: Randomization codes were obtained by a computerized random assignment generator program and the balanced randomization blocks were also randomized.After randomization codes were obtained, they were placed individually in envelopes and sequentially numbered. Sealed envelopes were sent to each participating site. Site staff opened the next available sequential randomization envelope to facilitate surgical planning, and participants were informed of the randomized procedure postoperatively. |
Intervention type | Procedure/Surgery |
Primary outcome measure | 1. Clinical outcome is evaluated by Oswestry disability index (ODI) and visual analogue scale (VAS) at baseline, 3, 6, 12, 24 m postoperatively 2. Radiological parameters include disc height(DH), fused segmental lordosis(FSL), lumbar lordosis (LL),cross-sectional area of the thecal sac(CSA),all of which are measured at baseline, 3, 6, 12, 24 m postoperatively 3. Interbody fusion rate(IFR) is measured using CT/X-ray at 6, 12, 24 m postoperatively. |
Secondary outcome measures | Measured after surgery using patient records: 1. Operation time(min) 2. Blood loss(ml) 3. First ambulation time(d) 4. Length of hospital stay(d) |
Overall study start date | 20/09/2018 |
Completion date | 30/09/2021 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Upper age limit | 80 Years |
Sex | Both |
Target number of participants | 224 |
Total final enrolment | 224 |
Key inclusion criteria | 1. LSS patients presenting with radicular symptom or neurogenic claudication, relieved by lying in bed rest, with or without low back pain 2. Disabling symptoms refractory to a minimum of 3 months of conservative treatment 3. Single-level (L2-L5) central canal, recess or neuroforamina stenosis estimated as Schizas C, D grade on radiologic imaging in consistent with clinical symptoms |
Key exclusion criteria | 1. Failure of relief of symptom by lying in bed rest 2. Congenital stenosis, ossification of ligamentum flavum or PLL, bony lateral recess stenosis, arthrodesis of facet joint, disc sequestration, complete loss of disc height 3. High grade spondylolistheis(IIIo or more) 4. Abnormal anatomy(limited corridor between major vessel and psoas ,anatomical variation of greater vessel); 5. Previous operation of left abdomen; 6. Infection, tumor, and so on |
Date of first enrolment | 01/11/2018 |
Date of final enrolment | 31/12/2021 |
Locations
Countries of recruitment
- China
Study participating centres
Suzhou
215006
China
Suzhou
215125
China
wuxi
214061
China
Zhenjiang
212001
China
Suzhou
215008
China
Sponsor information
Hospital/treatment centre
899 Pinghai Road
Suzhou
215006
China
Phone | +86 51267972285 |
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sdfyy@sina.com | |
Website | http://fyy.sdfyy.cn/ |
Funders
Funder type
Hospital/treatment centre
No information available
No information available
No information available
No information available
Results and Publications
Intention to publish date | 31/08/2024 |
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Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Available on request |
Publication and dissemination plan | Planned publication in a peer-reviewed journal |
IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Xuefeng Li (lixuefeng@suda.edu.cn) |
Editorial Notes
04/11/2024: Trial's existence confirmed by The Ethics Committee of The First Affiliated Hospital of Soochow University.