Clinical outcomes and quality of life 1 year after open microsurgical decompression or implantation of an interspinous stand-alone spacer.
BACKGROUND
Interspinous stand-alone implants are inserted without open decompression to treat symptomatic lumbar spinal stenosis (LSS). The insertion procedure is technically simple, low-risk, and quick. However, the question remains whether the resulting clinical outcomes compare with those of microsurgical decompression, the gold standard.


METHODS
This prospective, comparative study included all patients (n=36) with neurogenic intermittent claudication (NIC) secondary to LSS with symptoms improving in forward flexion treated operatively with either interspinous stand-alone spacer insertion (Aperius (®); Medtronic, Tolochenaz, Switzerland) (group 1) or microsurgical bilateral operative decompression (group 2) between February 2007 and November 2008. Data (patient data, operative data, COMI, SF-36 PCS and MCS, ODI, and walking tolerance) were collected preoperatively as well as at 6 weeks, at 3, 6, and 9 months, and at one year follow-up (FU). All patients had complete FU over 1 year.


RESULTS
Compared to preoperative measurements, surgery led to improvements of all parameters in the entire collective as well as both individual groups. There were no statistically relevant differences between the 2 groups over the entire course of FU. However, improvements in the ODI and SF-36 MCS were not significant in group 1, in contrast to those of group 2. Also, although in group 1 the improvements in leg pain (VAS leg) were still significant (p<0.05) at 6 months, this was no longer the case at 1 year FU. In group 1 at 1 year FU an increase in leg pain was observed, while in group 2,  minimal improvements continued. Walking tolerance was significantly improved at all FU times compared to preoperatively, regardless of group (p<0.01). At no time there was a significant difference between the groups. In group 1, admission and operative times were shorter and blood loss decreased. The complication rate was 0% in group 1 and 20% in group 2, however reoperation was required by 27.3% of group 1 patients and 0% of group 2.


CONCLUSIONS
Implantation of an interspinous stand-alone spacer yields clinical success comparable to open decompression, at least within the first year of FU. The 1-year conversion rate of 27.3% is, however, decidedly too high.
Department of Orthopaedic and Trauma Surgery, University of Cologne, Joseph-Stelzmann-Straße 9, Cologne, Germany. rolf.sobottke@uk-koeln.de
R
R
Sobottke
M
M
Röllinghoff
J
J
Siewe
U
U
Schlegel
A
A
Yagdiran
M
M
Spangenberg
R
R
Lesch
P
P
Eysel
T
T
Koy
D000368:Aged; D000369:Aged, 80 and over; D019299:Decompression, Surgical / Q000009:adverse effects* / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007383:Intermittent Claudication / Q000209:etiology / Q000601:surgery*; D008159:Lumbar Vertebrae / Q000601:surgery; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D019736:Prostheses and Implants / Q000009:adverse effects*; D019919:Prosthesis Implantation / Q000009:adverse effects / Q000379:methods; D011788:Quality of Life; D013130:Spinal Stenosis / Q000150:complications / Q000601:surgery*; D016896:Treatment Outcome