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| Name | Class |
|---|---|
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | OTHER |
| First Affiliated Hospital of Shantou University Medical College | OTHER |
| Shenzhen University | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified lateral lumbar interbody fusion | Experimental | Modified lateral lumbar interbody fusion for treatment of scoliosis |
|
| transforaminal lumbar interbody fusion | Active Comparator | transforaminal lumbar interbody fusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified lateral lumbar interbody fusion | Procedure | Modified lateral lumbar interbody fusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| ODI score | an index for assessing the lower back pain wiith multiple questionnare | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fangcai LI, Ph.D | Contact | 86-057187784594 | 89048991@qq.com | |
| Zhiwei WANG, Ph.D | Contact | 86-057187784594 | wangzhiwei929@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Qixin CHEN, Ph.D | Orthopedics Department, 2nd Hospital, School of Medicine, Zhejiang University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital, School of Medicine, Zejiang University | Recruiting | Hangzhou | Zhejiang | 310000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26537171 | Background | 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. | |
| 28296697 |
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after complete the recruiment with half of participants, we will share the preliminary results with data.
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| Background |
| Kretzer 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. |
| 24488750 | Background | Bach 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. |
| 27843677 | Result | Epstein 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. |
| 27843676 | Result | Epstein 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. |