Introduction
Criteria for considering studies for this review
Types of studies
Types of participants
Types of interventions
Types of outcome measures
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Functional disability (e.g. Roland Disability Questionnaire, Oswestry Disability Index).
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Perceived recovery.
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Leg pain.
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Length of hospital stay.
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Complication incidence.
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Surgically induced spinal instability.
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Paraspinal muscle denervation/atrophy.
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Muscle cell injury (creatine kinase level).
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Walking distance.
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Back pain.
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Length of surgical procedure.
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Perioperative blood loss.
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Postoperative use of analgesics.
Methods
Search methods for identification of studies
Assessment of risk of bias in included studies
Data extraction and management
Measures of treatment effect
Assessment of heterogeneity
Data synthesis
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75 % of studies have low risk of bias (six or more items met, including valid randomisation and treatment allocation techniques).
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Included studies have consistent findings.
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Included population adequately reflects selection criteria of the review.
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Results are based on direct comparison.
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Estimate of effect is sufficiently precise (confidence interval is narrow and conclusive).
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Analysis is free of publication bias (more than 75 % of studies contributed to the analysis).
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High-quality evidence: All domains were met; further research is very unlikely to change our confidence in the estimate of effect.
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Moderate-quality evidence: All but one domain were met; further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
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Low-quality evidence: All but two domains were met; 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.
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Very low-quality evidence: All but three domains were met; there is great uncertainty about the estimate of effect.
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No evidence: No RCTs were identified that addressed this outcome.
Results
Results of the search
Included studies
Reference | Design | Comparison groups | Number of participants | Age (years) | Male/female | Length of follow-up | Complete follow-up | Primary outcome |
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Gurelik [24] | RCT | 1) Unilateral laminotomy 2) Conventional laminectomy | 1) 26 2) 26 | 1) 61 ± 10 2) 58 ± 9 | 1) 11/15 2) 10/16 | 9.1 months | Not specified | ODI |
Yagi[25] | RCT | 1) Unilateral (endoscopic) laminotomy 2) Conventional laminectomy | 1) 20 2) 21 | 1) 73 (63-79) 2) 71 (66-73) | 1) 8/12 2) 6/15 | 1) 18.8 months 2) 18.6 months | Not specified | JOA |
Thome [4] | RCT | 1) Bilateral laminotomy 2) Unilateral laminotomy 3) Conventional laminectomy | 1) 37 2) 39 3) 34 | 1) 70 ± 7 2) 67 ± 9 3) 69 ± 10 | 1) 20/20 2) 15/25 3) 18/22 | 15.5 months | 1) 37/39 2) 39/40 3) 34/38 | RDQ, recovery, leg pain (improvement) |
Celik [2] | RCT | 1) Bilateral laminotomy 2) Conventional laminectomy | 1) 37 2) 34 | 1) 59 ± 14 2) 61 ± 13 | 1) 17/20 2) 16/18 | 1) 5.4 years 2) 5.3 years | 1) 37 of 40 lost to follow-up 2) 34 of 40 lost to follow-up | ODI, VAS leg pain |
Fu [26] | RCT | 1) Bilateral laminotomy 2) Conventional laminectomy | 1) 76 2) 76 | 1) 57 (47–70) 2) 57 (45–73) | 1) 37/39 2) 33/43 | 40.6 months | Not specified | ODI, recovery, VAS leg pain |
Postacchini [3] | RCT | 1) Bilateral laminotomy 2) Allocated to bilateral laminotomy but treated with conventional laminectomy 3) Conventional laminectomy | 1) 26 2) 9 3) 32 | 57 (43–79) | 34/36 | 3.7 years | 67/70 | Recovery, VAS leg pain (improvement) |
Cho [27] | RCT | 1) Split-spinous process laminotomy 2) Conventional laminectomy | 1) 40 2) 30 | 1) 61 ± 11 2) 59 ± 15 | 1) 16/24 2) 15/15 | 1) 15.1 months 2) 14.8 months | Not specified | JOA |
Liu [28] | RCT | 1) Split-spinous process with unilateral osteotomy and laminotomy 2) Conventional laminectomy | 1) 27 2) 29 | 1) 59 ± 5 2) 61 ± 3 | 1) 15/12 2) 18/11 | 2 years | Not specified | JOA, VAS leg pain |
Rajasekaran [29] | RCT | 1) Split-spinous process laminotomy 2) Conventional laminectomy | 1) 28 2) 23 | 1) 57 ± 11 2) 55 ± 8 | 1) 16/12 2) 14/9 | 14.2 months | 51/52 | JOA, VAS leg pain |
Watanabe [30] | RCT | 1) Split-spinous process laminotomy 2) Conventional laminectomy | 1) 18 2) 16 | 1) 69 ± 10 2) 71 ± 8 | 1) 10/8 2) 8/8 | 1 year | 32/34 | JOA |
Reference | Secondary outcome | Definition symptomatic lumbar stenosis | Mean duration of symptoms | Radiological definition of lumbar stenosis | Mean number of levels decompressed | Concomitant discectomy | Exclusion criteria |
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Gurelik [24] | Complications, instability, walking distance | Neurogenic claudication with or without radiculopathy | Not specified | Not specified | 1.7 levels | No | Vertebral instability, significant disc herniation and previous surgery for lumbar spine disorder |
Yagi[25] | Length of hospital stay, complications, instability, muscle atrophy, muscle cell injury, VAS back pain, operation duration, blood loss, analgesics | Neurogenic claudication with or without radiculopathy | At least 3 months and refractory to conservative treatment | Not specified | Only single level | No | > grade 1 spondylolisthesis, segmental instability, >1 level stenosis, herniated disc |
Thome [4] | Complications, instability, walking distance, VAS back pain (improvement), operation duration, blood loss | Neurogenic claudication with or without radiculopathy | At least 3 months and refractory to conservative treatment | Not specified | 1.7 levels | No | Herniated disc or instability (5 mm sagittal plane translation), history of lumbar stenosis surgery or lumbar fusion |
Celik [2] | Length of hospital stay, complications, instability, walking distance, VAS back pain, operation duration, blood loss, analgesics | Neurogenic claudication with or without radiculopathy | Not specified | Anteroposterior diameter of central canal <10 mm | 2.2 levels | No | Requiring discectomy, segmental instability |
Fu [26] | Complications, instability, walking duration, VAS back pain | Neurogenic claudication with or without radiculopathy | Refractory to conservative treatment | Anteroposterior diameter central canal <10 mm, lateral recess diameter <3 mm | 1.9 levels | No | Previous spinal surgery at the same level, isthmic spondylolisthesis, congenital spinal stenosis <8 mm caused by short pedicles, dynamic instability (sagittal translation >3 mm and angulation >10 degrees), cauda equina syndrome, active workers’ compensation claim, dying of other disease or loss to follow-up |
Postacchini [3] | VAS back pain (improvement), operation duration, blood loss | Requiring surgery, no specific symptoms of the condition defined | Not specified | Not specified | 1.7 levels | 8/67 | Not specified |
Cho [27] | Length of hospital stay, complications, instability, muscle cell injury, VAS back pain, operation duration, blood loss | Neurogenic claudication or lumbago | At least 6 months and refractory to conservative treatment | Anteroposterior diameter of central canal <11 mm, an interpediculate distance <16 mm or a lateral recess diameter <3 mm | 1) 2.5 levels 2) 2.6 levels | 1) 26/40 2) 18/30 | >80 years of age with high anaesthetic risks or severe co-morbidity, patients requiring concomitant fusion |
Liu [28] | VAS back pain, muscle atrophy, muscle cell injury, complications, instability, operation time, blood loss | Requiring surgery, no specific symptoms of the condition defined | Not specified | Not specified | 1.3 levels | No | Spondylolisthesis or vertebral instability |
Rajasekaran [29] | VAS back pain, muscle cell injury, blood loss, operating time, duration of hospital stay, complications | Neurogenic claudication with or without radiculopathy | At least 6 months and refractory to conservative treatment | Not specified | 1.6 levels | No | >3 levels, spondylolisthesis grade 2 or greater or vertebral instability (3 mm translation or 10 degree angular change), concomitant symptomatic cervical or thoracic stenosis, severe co-morbidities and prior lumbar spine surgery |
Watanabe [30] | Muscle cell injury, back muscle atrophy, blood loss, operating time, analgesics, complications | Neurogenic claudication with or without radiculopathy | At least 6 months and refractory to conservative treatment | Not specified | 1.4 levels | No | >3 levels; congenital, spondylolytic, traumatic and iatrogenic causes of lumbar stenosis; previous lumbar surgery; spinal disorders (such as ankylosing spondylitis, neoplasm or metabolic diseases); intermittent claudication resulting from peripheral arterial disease; severe osteoarthrosis or arthritis in the lower limbs; neurological disease causing impaired lower limb function; psychiatric disorders |
Excluded studies
Risk of bias in included studies
Random sequence generation (selection bias) | Allocation concealment (selection bias) | Blinding of participants to the intervention (performance bias) | Blinding of care provider to the intervention (performance bias) | Blinding of outcome assessor to the intervention (detection bias) | Drop out rate described and acceptable (attrition bias) | All randomised participants analysed in the group to which they were allocated (attrition bias) | Selective reporting (reporting bias) | Groups similar at baseline regarding important clinical prognostic indicators | Co-interventions avoided or similar | Compliance acceptable in treatment groups | Timing of the outcome assessment similar in treatment groups | |
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Gurelik [24] | Unsure | Unsure | Unsure | No | Unsure | Unsure | Yes | Yes | Yes | No | Yes | Yes |
Yagi [25] | No | No | Unsure | No | Unsure | Unsure | Yes | Yes | Unsure | Unsure | Yes | Yes |
Thome [4] | Yes | Yes | Unsure | No | Unsure | Unsure | Yes | Yes | Yes | Unsure | Yes | Yes |
Celik [2] | Yes | Yes | Yes | No | Unsure | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
Fu [26] | No | No | Unsure | Unsure | Unsure | Unsure | Yes | Yes | Yes | Unsure | Yes | Yes |
Postacchini [3] | No | No | Unsure | No | Yes | Yes | No | No | No | No | Yes | Unsure |
Cho [27] | Unsure | Unsure | Unsure | No | Unsure | Unsure | Yes | Yes | No | Yes | Yes | Yes |
Liu [28] | Unsure | Unsure | Unsure | No | Unsure | Unsure | Yes | No | Yes | Unsure | Yes | Unsure |
Rajasekaran [29] | Yes | Unsure | Unsure | No | Yes | Yes | Yes | Yes | Yes | Unsure | Yes | Unsure |
Watanabe [30] | Yes | Yes | Yes | No | Unsure | Yes | Yes | Yes | Yes | Yes | Yes | Unsure |
Effects of interventions
Disability
Unilateral laminotomy compared with conventional laminectomy | ||||||
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Outcomes | Comparisons | Relative effect (95 % CI) | Number of participants (studies) | Quality of the evidence (GRADE) | Comments | |
Conventional laminectomy | Unilateral laminotomy | |||||
Standardised disability index (0–100) Disability scores converted to 0–100 scale to allow for comparison of RDQ, ODI, JOA | Standardised disability index score 30.9 (range 23.0–35.8) | Standardised disability index score 29.8 (range 15.8–45.4) | Mean difference −1.11 (−11.91, 9.69) The difference is not statistically significant | Lowa,b
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Satisfactory recovery Satisfactory recovery was defined as ‘good’ or ‘excellent’ self-perceived recovery | 25 of 34 (74 of 100) participants | 29 of 39 (74 of 100) participants | OR 1.04 (0.37, 2.98) The difference is not statistically significant | 73 (1) [4] | Lowc
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VAS leg (0–10) | Mean VAS leg score not estimable | Mean VAS leg score not estimable | Mean difference not estimable | 0 (0) | Lowc
| The outcome reporting of one study was not suitable for quantitative comparison [4]. No statistically significant difference regarding leg pain at rest or during walking was reported |
VAS back (0–10) | Mean VAS back score not estimable | Mean VAS back score not estimable | Mean difference not estimable | 0 (0) | Very lowa,b,d
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Incidence of postoperative instability | 10 of 81 (12 of 100) participants | 2 of 85 (2 of 100) participants | OR 0.28 (0.07, 1.15) The difference is not statistically significant | Lowa,b
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Incidence of perioperative complications | 9 of 87 (10 of 100) participants | 7 of 86 (8 of 100) participants | OR 0.73 (0.24, 2.20) The difference is not statistically significant | Lowa,b
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Bilateral laminotomy compared with conventional laminectomy | ||||||
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Conventional laminectomy | Bilateral laminotomy | |||||
Standardised disability Index (0–100) Disability scores converted to 0–100 scale to allow for comparison of RDQ, ODI, JOA | Mean standardised disability index score 5.2 (range 3.4–35.8) | Mean standardised disability index score 2.5 (range 0.4–33.8) | Mean difference −2.73 (−4.59, −0.87) The difference is not clinically significant | Very lowa,b,e
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Satisfactory recovery Satisfactory recovery was defined as ‘good’ or ‘excellent’ self-perceived recovery | 73 of 110 (66 of 100) participants | 104 of 113 (92 of 100) participants | OR 5.69 (2.55, 12.71) The difference is statistically significant in favour of bilateral laminotomy | Lowa,e
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VAS leg (0–10) | Mean VAS leg score 0.6 (range 0.36–2.3) | Mean VAS leg score 0.3 (range 0.01–2.5) | Mean difference −0.29 (−0.48, −0.11) The difference is not clinically significant | Very lowa,b,e
| The outcome reporting of two studies was not suitable for quantitative comparison. A statistically significant difference regarding leg pain at rest and during walking was reported in favour of bilateral laminotomy by Thome et al., whilst Postacchini et al. found no statistically significant difference [3, 4] | |
VAS back (0–10) | Mean VAS leg score 1.3 (range 0.63–4.4) | Mean VAS leg score 0.8 (range 0.05–4.2) | Mean difference −0.51 (−0.80, −0.23) The difference is not clinically significant | Lowa,e
| The outcome reporting of two studies was not suitable for quantitative comparison. Thome et al. reported no statistically significant difference regarding improvement in back pain at rest, but back pain during walking favoured participants treated with bilateral laminotomy [4]. Postacchini et al. reported a significant improvement in VAS back pain among participants treated with bilateral laminotomy compared with those who underwent conventional laminectomy [3] | |
Incidence of postoperative instability | 12 of 144 (8 of 100) participants | 0 of 150 (0 of 100) participants | OR 0.10 (0.02, 0.55) The difference is statistically significant in favour of bilateral laminotomy | Lowa,f
| The outcome reporting of one study was not suitable for quantitative comparison. Postacchini et al. reported no postoperative instability in the bilateral laminotomy group compared with 3/41 participants treated with conventional laminectomy [3] |
Split-spinous process laminotomy compared with conventional laminectomy | ||||||
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Conventional laminectomy | Split-spinous process laminotomy | |||||
Standardised disability index (0–100) Disability scores converted to–100 scale to allow for comparison of RDQ, ODI, JOA | Mean standardised disability index score 13.2 (range 12.4–17.2) | Mean standardised disability index score 11.6 (range 7.9–20.3) | Mean difference −1.68 (−8.50, 5.13) The difference is not statistically significant | Lowa,b
| The outcome reporting of one study was not suitable for quantitative comparison. No statistically significant difference regarding functional disability was reported by Cho et al. [27] | |
Satisfactory recovery Satisfactory recovery was defined as ’good’ or ’excellent’ self-perceived recovery | Satisfactory recovery not estimable | Satisfactory recovery not estimable | OR not estimable | 0 (0) | NA | |
VAS leg (0–10) | Mean VAS leg score 1.7 (range 1.7–1.74) | Mean VAS leg score 1.4 (range 1.3–1.93) | Mean difference −0.29 (−0.41, −0.17) The difference is not clinically significant | Very lowa,b,g
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VAS back (0–10) | Mean VAS leg score 2.8 (range 2.6–3.0) | Mean VAS leg score 1.7 (range 1.0–2.5) | Mean difference −1.07 (−2.15, −0.00) The difference is not clinically significant | Very lowa,b,g
| The outcome reporting of one study was not suitable for quantitative comparison. A statistically and clinically significant difference in favour of split-process laminotomy was reported by Cho et al. [28] | |
Incidence of postoperative instability | Postoperative instability not estimable | Postoperative instability not estimable | OR was not estimable | Very lowh
| The outcome reporting of one study was not suitable for quantitative comparison. No statistically significant difference regarding postoperative instability was reported by Liu et al. [27] | |
Incidence of perioperative complications | 4 of 68 (6 of 100) participants | 5 of 73 (7 of 100) participants | OR 1.21 (0.20, 7.16) The difference is not statistically significant | Lowa,b
| The outcome reporting of one study was not suitable for quantitative comparison. No statistically significant difference regarding perioperative complications was reported by Cho et al. [27] |