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2013년 12월 23일 월요일

Decompression and Coflex interlaminar stabilization compared with decompression and instrumented spinal fusion for spinal stenosis and low-grade degenerative spondylolisthesis

Brief review


*Title: Decompression and Coflex interlaminar stabilization compared with decompression and instrumented spinal fusion for spinal stenosis and low-grade degenerative spondylolisthesis
:two-year results from the prospective, randomized, multicenter, Food and Drug Administration Investigational Device Exemption trial.

요추 협착증과 낮은 단계의 퇴행성 척추전방전위증 치료를 위한 감압술 & Conflex(고정체)를 이용한 추궁간판 안정화술과 감압술 & 요추유합술 비교.
:전향적, 무작위배정, 다기관, FDA-IDE연구


*Authors: Davis RJ, Errico TJ, Bae H, Auerbach JD.




STUDY DESIGN
Prospective, randomized, multicenter, Food and Drug Administration Investigational Device Exemption trial (FDA- IDE)


OBJECTIVE
To evaluate the safety and efficacy of Coflex interlaminar stabilization compared with posterior spinal fusion in the treatment of 1- and 2-level spinal stenosis and degenerative spondylolisthesis.


SUMMARY OF BACKGROUND DATA
Lumbar fusion for stenosis and degenerative spondylolisthesis have led to the search for motion-preserving, less-invasive alternatives.


METHODS
Subject: total 322 patients (2006~2010)
-Randomized to receive laminectomy & Coflex interlaminar stabilization(215) or laminectomy & posterolateral spinal fusion(107)   -->2:1 ratio

Evaluating methods: ODI, reoperations, complications, postoperative epidural injections


RESULTS
Follow-up: 95.3% (Coflex) / 97.2% (fusion) –min 2 yrs.
Results:
-Operative times: conflex < fusion
- blood loss: conflex < fusion
- length of stay: conflex < fusion
-ODI improvement: conflex > fusion
-VAS improvement: both groups
-SF-12 improvement: conflex > fusion
-Zurich Claudication Questionnaire
-Reoperation rate: conflex (10.7%) > fusion (7.5%) (p = 0.426)
-Overall success rate: Coflex (66.2%) > fusion (57.7%) (p = 0.999) -Based on the FDA.

>Coflex significantly improve in all outcomes measures compared with fusion: symptom severity (p = 0.023); physical function (p = 0.008); satisfaction (p = 0.006)

>At 2 yrs, fusions increased angulation (P = 0.002) and a trend toward increased translation (p= 0.083) at the superior adjacent level. Whereas Coflex maintained normal operative and adjacent level motion.


CONCLUSION
Coflex interlaminar stabilization is a safe and efficacious alternative compared with lumbar spinal fusion for spinal stenosis and low-grade spondylolisthesis.