Laminectomy plus Fusion versus Laminectomy Alone for Lumbar Spondylolisthesis

被引:640
作者
Ghogawala, Zoher [1 ,4 ]
Dziura, James [5 ]
Butler, William E. [2 ]
Dai, Feng [5 ]
Terrin, Norma [3 ]
Magge, Subu N. [1 ]
Coumans, Jean-Valery C. E. [2 ]
Harrington, J. Fred [6 ]
Amin-Hanjani, Sepideh [7 ]
Schwartz, J. Sanford [8 ,9 ,10 ]
Sonntag, Volker K. H. [11 ]
Barker, Fred G., II [2 ]
Benzel, Edward C. [12 ,13 ]
机构
[1] Lahey Hosp & Med Ctr, Dept Neurosurg, Alan L & Jacqueline B Stuart Spine Res Ctr, Burlington, MA 01805 USA
[2] Massachusetts Gen Hosp, Dept Neurosurg, Boston, MA 02114 USA
[3] Tufts Univ, Sch Med, Tufts Clin & Translat Sci Inst, Boston, MA 02111 USA
[4] Greenwich Hosp, Wallace Trials Ctr, Greenwich, CT USA
[5] Yale Univ, Sch Publ Hlth, Yale Ctr Analyt Sci, New Haven, CT USA
[6] Univ New Mexico, Dept Neurosurg, Albuquerque, NM 87131 USA
[7] Univ Illinois, Dept Neurosurg, Chicago, IL USA
[8] Univ Penn, Perelman Sch Med, Philadelphia, PA 19104 USA
[9] Univ Penn, Wharton Sch Business, Philadelphia, PA 19104 USA
[10] Univ Penn, Leonard Davis Inst, Philadelphia, PA 19104 USA
[11] Barrow Neurol Inst, Barrow Neurosurg Associates, Phoenix, AZ 85013 USA
[12] Cleveland Clin Fdn, Ctr Spine Hlth, 9500 Euclid Ave, Cleveland, OH 44195 USA
[13] Cleveland Clin Fdn, Dept Neurosurg, 9500 Euclid Ave, Cleveland, OH 44195 USA
关键词
OUTCOMES RESEARCH TRIAL; LOW-BACK-PAIN; DEGENERATIVE SPONDYLOLISTHESIS; SPINAL STENOSIS; REOPERATION RATES; GUIDELINE UPDATE; COST-UTILITY; DECOMPRESSION; PERFORMANCE; RATIONALE;
D O I
10.1056/NEJMoa1508788
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
BACKGROUND The comparative effectiveness of performing instrumented (rigid pedicle screws affixed to titanium alloy rods) lumbar spinal fusion in addition to decompressive laminectomy in patients with symptomatic lumbar grade I degenerative spondylolisthesis with spinal stenosis is unknown. METHODS In this randomized, controlled trial, we assigned patients, 50 to 80 years of age, who had stable degenerative spondylolisthesis (degree of spondylolisthesis, 3 to 14 mm) and symptomatic lumbar spinal stenosis to undergo either decompressive laminectomy alone (decompression-alone group) or laminectomy with posterolateral instrumented fusion (fusion group). The primary outcome measure was the change in the physical-component summary score of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36; range, 0 to 100, with higher scores indicating better quality of life) 2 years after surgery. The secondary outcome measure was the score on the Oswestry Disability Index (range, 0 to 100, with higher scores indicating more disability related to back pain). Patients were followed for 4 years. RESULTS A total of 66 patients (mean age, 67 years; 80% women) underwent randomization. The rate of follow-up was 89% at 1 year, 86% at 2 years, and 68% at 4 years. The fusion group had a greater increase in SF-36 physical-component summary scores at 2 years after surgery than did the decompression-alone group (15.2 vs. 9.5, for a difference of 5.7; 95% confidence interval, 0.1 to 11.3; P = 0.046). The increases in the SF-36 physical-component summary scores in the fusion group remained greater than those in the decompression-alone group at 3 years and at 4 years (P = 0.02 for both years). With respect to reductions in disability related to back pain, the changes in the Oswestry Disability Index scores at 2 years after surgery did not differ significantly between the study groups (-17.9 in the decompression-alone group and -26.3 in the fusion group, P = 0.06). More blood loss and longer hospital stays occurred in the fusion group than in the decompression-alone group (P< 0.001 for both comparisons). The cumulative rate of reoperation was 14% in the fusion group and 34% in the decompression-alone group (P = 0.05). CONCLUSIONS Among patients with degenerative grade I spondylolisthesis, the addition of lumbar spinal fusion to laminectomy was associated with slightly greater but clinically meaningful improvement in overall physical health-related quality of life than laminectomy alone.
引用
收藏
页码:1424 / 1434
页数:11
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