Interspinous process device versus standard conventional surgical decompression for lumbar spinal stenosis: randomized controlled trial

Brief review

이 논문은 요추 협착증의 치료방법으로서 극돌기간 삽입체와 기존의 감압술을 비교한 무작위 대조군 연구 입니다.

술 후 8주 이내의 짧은 기간 내에서, 극돌기간 고정체 삽입술이 감압술에 비해 효과적인가를 평가하기 위한 것이 목적 입니다.

2008년 10월부터 2011년 9월까지 1 or 2분절에 요추 협착증이 있어 NIC(신경성 간헐적 보행장애)를 보이는 환자 159명을 대상으로 무작위, 이중맹검으로 수술을 시행하였고, 수술 후 8주차, 1년차에 각각 ZCQ(보행장애와 관련된 설문)을 통해 success rate를 평가했습니다.

평가결과, 8주차에는 interspinous그룹이 decompression그룹에 비해 성공률이 월등히 높지는 않았고, 1년 차에도 두 그룹간에 차이가 없었습니다.

결론적으로, 이 연구에서는 단기간 내, interspinous process device 삽입술이 decompression에 비해 우수하다는 것을 증명하지 못했으며, 오히려 interspinous process device삽입술이 decompression에 비해 유의하게 재 수술률이 높은 것으로 나타났습니다.

*Title: Interspinous process device versus standard conventional surgical decompression for lumbar spinal stenosis: randomized controlled trial.

*Authors: Moojen WA, Arts MP, Jacobs WC, van Zwet EW, van den Akker-van Marle ME, Koes BW, Vleggeert-Lankamp CL, Peul WC

*Bibliography: BMJ.2013 Nov 14; 347: f6415.

OBJECTIVE

To assess whether interspinous process device implantation is more effective in the short term than conventional surgical decompression for patients with intermittent neurogenic claudication due to lumbar spinal stenosis.

DESIGN

Randomized controlled trial

(prospective, randomized, double blind, multicenter trial)

SETTING

5neurosurgical centers (including one academic and four secondary level care centers) in the Netherlands.

PARTICIPANTS

▶Enrollment period: 2008.10~2011.09

▶Subject number: 159 participants (with intermittent neurogenic claudication due to lumbar spinal stenosis at 1 or 2 levels)

INTERVENTIONS

Total 159 patients (80 interspinous process device group + 79 spinal bony decompression group)

MAIN OUTCOME MEASURES

▶Measurement method: Zurich Claudication Questionnaire score (ZCQ)

▶Follow-up period: 1) primary outcome at short term (8weeks), 2) long term (1year)

-Repeated measurements were made to compare outcomes over time.

RESULTS

▶Success rate(ZCQ)

1) short term F/U(8wks): interspinous process device group (63%, 95% confidence interval 51% to 73%) was not superior to that for standard bony decompression (72%, 60% to 81%).

2) long term F/U(1yr): No differences in disability (ZCQ; p=0.44) or other outcomes were observed between groups

-The repeat surgery rate: interspinous implant group was substantially higher (n=21; 29%) than that in the conventional group (n=6; 8%) in the early post-surgical period (P<0.001).

CONCLUSIONS

-This double blinded study could not confirm the hypothesized short term advantage of interspinous process device over conventional "simple" decompression.

-After interspinous process device implantation, showed a fairly high reoperation rate.