دورية أكاديمية
Results of the prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of the ProDisc-L total disc replacement versus circumferential fusion for the treatment of 1-level degenerative disc disease.
| العنوان: | Results of the prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of the ProDisc-L total disc replacement versus circumferential fusion for the treatment of 1-level degenerative disc disease. |
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| المؤلفون: | Zigler J; Texas Back Institute/Texas Health Research Institute, Plano, TX 75093, USA. jzigler@texasback.com, Delamarter R, Spivak JM, Linovitz RJ, Danielson GO 3rd, Haider TT, Cammisa F, Zuchermann J, Balderston R, Kitchel S, Foley K, Watkins R, Bradford D, Yue J, Yuan H, Herkowitz H, Geiger D, Bendo J, Peppers T, Sachs B, Girardi F, Kropf M, Goldstein J |
| المصدر: | Spine [Spine (Phila Pa 1976)] 2007 May 15; Vol. 32 (11), pp. 1155-62; discussion 1163. |
| نوع المنشور: | Journal Article; Multicenter Study; Randomized Controlled Trial |
| اللغة: | English |
| بيانات الدورية: | Publisher: Lippincott Williams & Wilkins Country of Publication: United States NLM ID: 7610646 Publication Model: Print Cited Medium: Internet ISSN: 1528-1159 (Electronic) Linking ISSN: 03622436 NLM ISO Abbreviation: Spine (Phila Pa 1976) Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: Hagerstown, MD : Lippincott Williams & Wilkins Original Publication: Hagerstown, Md., Medical Dept., Harper & Row. |
| مواضيع طبية MeSH: | Lumbar Vertebrae* , Spinal Fusion*, Arthroplasty, Replacement/*instrumentation , Intervertebral Disc/*surgery , Low Back Pain/*etiology , Spinal Diseases/*surgery, Adult ; Arthroplasty, Replacement/adverse effects ; Device Approval ; Disability Evaluation ; Female ; Follow-Up Studies ; Humans ; Intervertebral Disc/diagnostic imaging ; Intervertebral Disc/physiopathology ; Low Back Pain/drug therapy ; Low Back Pain/surgery ; Male ; Middle Aged ; Narcotics/therapeutic use ; Pain Measurement ; Patient Satisfaction ; Prospective Studies ; Prosthesis Design ; Radiography ; Range of Motion, Articular ; Recovery of Function ; Spinal Diseases/complications ; Spinal Diseases/diagnostic imaging ; Spinal Diseases/physiopathology ; Time Factors ; Treatment Outcome ; United States ; United States Food and Drug Administration |
| مستخلص: | Study Design: A prospective, randomized, multicenter, Food and Drug Administration-regulated Investigational Device Exemption clinical trial. Objective: To evaluate the safety and effectiveness of the ProDisc-L (Synthes Spine, West Chester, PA) lumbar total disc replacement compared to circumferential spinal fusion for the treatment of discogenic pain at 1 vertebral level between L3 and S1. Summary of Background Data: As part of the Investigational Device Exemption clinical trial, favorable single center results of lumbar total disc replacement with the ProDisc-L have been reported previously. Methods: Two hundred eighty-six (286) patients were treated on protocol. Patients were evaluated before and after surgery, at 6 weeks, 3, 6, 12, 18, and 24 months. Evaluation at each visit included patient self-assessments, physical and neurologic examinations, and radiographic evaluation. Results: Safety of ProDisc-L implantation was demonstrated with 0% major complications. At 24 months, 91.8% of investigational and 84.5% of control patients reported improvement in the Oswestry Low Back Pain Disability Questionnaire (Oswestry Disability Index [ODI]) from preoperative levels, and 77.2% of investigational and 64.8% of control patients met the > or =15% Oswestry Disability Index improvement criteria. Overall neurologic success in the investigational group was superior to the control group (91.2% investigational and 81.4% control; P = 0.0341). At 6 weeks and 3 months follow-up time points, the ProDisc-L patients recorded SF-36 Health Survey scores significantly higher than the control group (P = 0.018, P = 0.0036, respectively). The visual analog scale pain assessment showed statistically significant improvement from preoperative levels regardless of treatment (P < 0.0001). Visual analog scale patient satisfaction at 24 months showed a statistically significant difference favoring investigational patients over the control group (P = 0.015). Radiographic range of motion was maintained within a normal functional range in 93.7% of investigational patients and averaged 7.7 degrees. Conclusions: ProDisc-L has been found to be safe and efficacious. In properly chosen patients, ProDisc-L has been shown to be superior to circumferential fusion by multiple clinical criteria. |
| التعليقات: | Comment in: Spine (Phila Pa 1976). 2007 Dec 1;32(25):2929-30; author reply 2930-1. (PMID: 18246024) Comment in: Orthopade. 2012 Dec;41(12):991. (PMID: 23192730) |
| المشرفين على المادة: | 0 (Narcotics) |
| تواريخ الأحداث: | Date Created: 20070515 Date Completed: 20070604 Latest Revision: 20220331 |
| رمز التحديث: | 20240628 |
| DOI: | 10.1097/BRS.0b013e318054e377 |
| PMID: | 17495770 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1528-1159 |
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| DOI: | 10.1097/BRS.0b013e318054e377 |