Summary of findings 3. SUMMARY OF FINDINGS FOR FUSION VERSUS INTERSPINOUS SPACERS.
| Decompression plus fusion compared with interspinous spacers for lumbar spinal stenosis | ||||||
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Patient or population: patients with lumbar spinal stenosis Settings: inpatient care Intervention: decompression plus fusion Comparison: interspinous process spacer devices | ||||||
| Outcomes | Comparisons | Relative effect (95% CI) | Number of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Decompression and fusion | Interspinous spacer devices | |||||
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Pain Long‐term (≥ 12 months) Pain scores converted to 0 to 100 scale to allow for comparison of different disability scales (VAS, NRS) |
The mean pain score ranged across fusion groups from 24.10 to 35.50 points | The mean pain score in the interspinous spacers groups was 5.35 lower (11.88 lower to 1.18 higher) | Mean difference 5.35 (‐1.18, 11.88) | 308 (2) | ⊕⊕⊝⊝ Low | The difference is not statistically or clinically significant |
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Disability Long‐term (≥ 12 months) Disability scores converted to 0 to 100 scale to allow for comparison of different disability scales (RMDQ, ODI, JOA) |
The mean disability score ranged across fusion groups from 26.70 to 34.50 points | The mean disability score in the interspinous spacers groups was 5.72 lower (1.28 to 10.15 lower) | Mean difference 5.72 (1.28, 10.15) | 308 (2) | ⊕⊕⊝⊝ Low | The difference is not clinically significant |
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Operation time Duration of operation reported in minutes |
The mean operation time ranged across fusion groups from 150.00 to 153.20 minutes | The mean operation time in the interspinous spacers groups was 78.91 lower (30.16 to 127.65 lower) | Mean difference 78.91 (30.16, 127.65) | 381 (2) | ⊕⊝⊝⊝ Very low | The difference is clinically significant |
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Blood loss Amount of perioperative blood loss reported in mL |
The mean perioperative blood loss in the fusion group was 348.60 mL | The mean perioperative blood loss in the interspinous spacers groups was 238.90 mL lower (182.66 to 295.14 mL lower) | Mean difference 238.90 (182.66, 295.14) | 320 (1) | ⊕⊕⊕⊝ Moderate | The difference is clinically significant |
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Reoperations Number of patients requiring a revision surgery |
8 of 107 (7 per 100) participants had reoperation | 23 of 215 (11 per 100) participants had reoperation | Risk ratio 0.70 (0.32, 1.51) | 322 (1) | ⊕⊕⊕⊕ High | The difference is not statistically or clinically significant |
| CI: confidence interval; RR: risk ratio; VAS: visual analogue scale; NRS: numerical rating scale; RMDQ: Roland‐Morris Disability Questionnaire; ODI: Oswestry Disability Index; JOA: Japanese Orthopedic Association | ||||||
| GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. | ||||||