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.

*Bibliography: Spine (Phila Pa 1976). 2013Aug 15;38(18):1529-39.

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.

Interspinous spacers compared with decompression or fusion for lumbar stenosis: complications and repeat operations in the medicare population

Brief review

*Title: Interspinous spacers compared with decompression or fusion for lumbar stenosis: complications and repeat operations in the medicare population.

*Author: Richard A. Deyo, Brook I. Martin, Alex Ching, Anna N. A. Tosteson, Jeffrey G. Jarvik, William Kreuter, Sohail K. Mirza.

*Bibliography: Spine (Phila Pa 1976). 2013 May1;38(10):865-72.

STUDY DESIGN

Retrospective cohort analysis of Medicare claims for 2006-2009.

OBJECTIVE

To examine whether interspinous distraction procedures are 1)used selectively in patients with more advanced age or comorbidity.

2)associated with fewer complications, lower costs, and less revision surgery than laminectomy or fusion surgery.

SUMMARY OF BACKGROUND DATA

There are few population-based data evaluating patterns of interspinous spacer surgery and nonsurgical care.

METHODS

Medicare inpatient claims data divided into 4 groups. (with stenosis undergoing surgery, n = 99,084)

(1) interspinous process spacer alone

(2) laminectomy and a spacer

(3) decompression alone

(4) lumbar fusion (1-2 level)

-To compare age and comorbidity, cost of surgery, rates of revision surgery, major medical complications, wound complications, mortality, and 30-day readmission rates.

RESULTS

▶Age: received spacers > decompression or fusion

▶Comorbidity: received spacers > decompression or fusion

▶Complications (major medical): spacer alone < decompression or fusion surgery

▶Hospital payments: fusion procedures > spacer surgery > decompression alone

-These associations persisted in multivariate models adjusting for patient age, sex, comorbidity score, and previous hospitalization.

CONCLUSION

Interspinous distraction procedures fewer complications, higher rates of revision surgery to compared with decompression or fusion.

Who should have surgery for spinal stenosis?: Treatment effect predictors in SPORT

Brief review

*Title: Who should have surgery for spinal stenosis?: Treatment effect predictors in SPORT.

누가 척추 협착증을 위한 수술을 받아야 하는가?

: SPORT(Spine Patient Outcome Research Trial)에서의 치료효과의 예측변수

*Author: Adam Pearson, Jon Lurie, Tor Tosteson, Wenyan Zhao, William Abdu, James N. Weinstein

*Bibliography: Spine(Phila Pa 1976). 2012 Oct 1;37(21):1791-802.

STUDY DESIGN: Combined prospective randomized controlled trial and observational cohort study of spinal stenosis (SpS) with an as-treated analysis.

OBJECTIVE: To determine modifiers of the treatment effect (TE) of surgery (the difference between surgical and nonoperative outcomes) for SpS using subgroup analysis.

SUMMARY OF BACKGROUND DATA: The Spine Patient Outcomes Research Trial demonstrated a positive surgical TE for SpS at the group level. However, individual characteristics may affect TE. No previous studies have evaluated TE modifiers in SpS.

METHODS:

▶Study design: Spinal stenosis patients were treated with either surgery (n = 419) or nonoperative care (n = 235) and were analyzed according to treatment received.

▶Patient Population

-Inclusion criteria: had neurogenic claudication or radicular pain for at least 12 weeks, a confirmatory cross-sectional imaging study demonstrating stenosis at 1 or more levels.

-Exclusion criteria: cauda equina syndrome, malignancy, significant deformity, previous back surgery, instability on flexion-extension radiographs, and other established contraindications to elective surgery.

▶Statistical Considerations: The TE of surgery was defined as:

TE (Treatment Effect)= change in ODI (surgery) – change in ODI (nonoperative)

RESULTS:

-All analyzed subgroups improved significantly more with surgery than with nonoperative treatment 

(P < 0.05).

-Details of the below were associated with greater TE.

baseline ODI ≤ 56 (TE -15.0 vs. -4.4, ODI > 56, P < 0.001),

not smoking (TE -11.7 vs. -1.6 smokers, P < 0.001),

neuroforaminal stenosis (TE -14.2 vs. -8.7 no neuroforaminal stenosis, P = 0.002),

predominant leg pain (TE -11.5 vs. -7.3 predominant back pain, P = 0.035),

not lifting at work (TE -12.5 vs. -0.5 lifting at work, P = 0.017),

the presence of a neurological deficit (TE -13.3 vs. -7.2 no neurological deficit, P < 0.001).

CONCLUSION:

-Patients improved more with surgery than with nonoperative treatment, regardless of other specific characteristics.

-However, TE varied significantly across certain subgroups, and these data can be used to individualize shared decision making discussions about likely outcomes.

Key Points

●Other than smokers, all patient subgroups improved more with surgery than with nonoperative treatment.

●Baseline ODI score less than 56, not smoking, neuroforaminal stenosis, predominant leg pain, not lifting at work, and baseline neurological deficit predicted a greater TE of surgery.

●Smoking cessation should be considered before surgery for SpS.

●These data can be used to help to individualize shared decision-making discussions about likely outcomes after surgical or nonoperative treatment for SpS.