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Research ArticleEndoscopic Minimally Invasive Surgery

Full-Endoscopic Lumbar Discectomy vs Standard Discectomy: A Noninferiority Study on Clinically Relevant Changes

Joel Beck, Olof Westin, Mikael Klingenstierna and Adad Baranto
International Journal of Spine Surgery June 2023, 17 (3) 364-369; DOI: https://doi.org/10.14444/8458
Joel Beck
1 Department of Orthopaedics, Institute of Clinical Sciences at Sahlgrenska Academy, University of Gothenburg and Sahlgrenska University Hospital, Gothenburg, Sweden
MD, PhD
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  • For correspondence: joel.beck@vgregion.se
Olof Westin
1 Department of Orthopaedics, Institute of Clinical Sciences at Sahlgrenska Academy, University of Gothenburg and Sahlgrenska University Hospital, Gothenburg, Sweden
MD, PhD
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Mikael Klingenstierna
1 Department of Orthopaedics, Institute of Clinical Sciences at Sahlgrenska Academy, University of Gothenburg and Sahlgrenska University Hospital, Gothenburg, Sweden
MD
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Adad Baranto
1 Department of Orthopaedics, Institute of Clinical Sciences at Sahlgrenska Academy, University of Gothenburg and Sahlgrenska University Hospital, Gothenburg, Sweden
MD, PhD
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    Table 1

    MIC and PASSa values used in the study.

    Outcome MeasureMICPASS LevelComment
    Leg pain NRS (0–10)3.52NRS
    Back pain NRS (0–10)2.52NRS
    Oswestry Disability Index (0–100)−2022Composite score
    • Abbreviations: MIC, minimal important change; NRS, numerical rating scale; PASS, patient acceptable symptom state.

    • ↵a PASS indicates the highest score on that scale that is acceptable to a generalized population.

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    Table 2

    Demographic parameters at baseline.

    CharacteristicFELD Group (n = 80)Control Group (n = 400) P ValueDifference Between Groups,
    Mean (95% CI)
    Age, y, n = 80 n = 400
     Mean (SD) (95% CI for mean)32.4 (10.4) (30.1; 34.7)33.2 (10.0) (32.2; 34.2)0.53−0.763 (−3.209; 1.682)
    Sex, n (%) n = 80 n = 400
     Men41 (51.3%)205 (51.3%)0.0 (−12.7; 12.7)
     Women39 (48.8%)195 (48.8%)>0.990.0 (−12.7; 12.7)
    Body mass index n = 80 n = 400
     Mean (SD) (95% CI for mean)25.0 (4.0) (24.1; 25.9)25.3 (3.3) (25.0; 25.6)0.46−0.309 (−1.173; 0.504)
    Smoker, n (%) n = 69 n = 398
     No59 (85.5%)343 (86.2%)−0.7 (−10.5; 9.1)
     Yes10 (14.5%)55 (13.8%)>0.990.7 (−9.1; 10.5)
    Leg pain (NRS 0–10) n = 56 n = 389
     Mean (SD) (95% CI for mean)7.34 (1.98) (6.81; 7.87)6.99 (2.18) (6.78; 7.21)0.270.347 (−0.231; 0.936)
    Back pain (NRS 0–10) n = 56 n = 388
     Mean (SD) (95% CI for mean)5.11 (2.74) (4.37; 5.84)4.81 (2.83) (4.53; 5.09)0.450.295 (−0.510; 1.080)
    Duration of leg pain, n (%) n = 80 n = 400
     <3 mo6 (7.5%)30 (7.5%)
     3–12 mo49 (61.3%)245 (61.3%)
     12–24 mo13 (16.3%)65 (16.3%)
     >24 mo12 (15.0%)60 (15.0%)>0.99
    Oswestry Disability Index n = 55 n = 392
     Mean (SD) (95% CI for mean)46.5 (18.5) (41.5; 51.5)46.5 (17.8) (44.7; 48.3)0.97−0.007 (−4.939; 4.958)
    Lumbar disc herniation level, n (%) n = 80 n = 400
     L4-L525 (31.3%)153 (38.3%)−7.0 (−19.0; 5.0)
     L5-S155 (68.8%)247 (61.8%)0.297.0 (−5.0; 19.0)
    • Abbreviations: FELD, full-endoscopic lumbar discectomy; NRS, numerical rating scale.

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    Table 3

    Postoperative patient-reported outcome measures for FELD and Swespine controls.

    Patient-Reported Outcome MeasureFELD Group
    (n = 80)
    Control Group
    (n = 400)
    P ValueDifference Between Groups,
    Mean (95% CI)
    NRSLeg (1 y) n = 67 n = 223
     Mean (SD) (range)2.69 (2.68) (2.03; 3.34)1.97 (2.49) (1.64; 2.30)0.0650.718 (−0.040; 1.429)
    NRSLeg decrease n = 43 n = 219
     Mean (SD) (range)−4.35 (2.93) (−5.25; −3.45)−4.99 (3.12) (−5.40; −4.57)0.240.637 (−0.421; 1.657)
    NRSLeg % change n = 43 n = 219
     Mean (SD) (range)−60.2 (36.7) (−71.4; −48.9)−65.3 (65.0) (−73.9; −56.6)0.575.13 (−18.07; 22.31)
    NRSBack(1 y) n = 62 n = 224
     Mean (SD) (range)2.56 (2.38) (1.96; 3.17)2.34 (2.46) (2.02; 2.67)0.540.221 (−0.444; 0.891)
    NRSBack decrease n = 36 n = 200
     Mean (SD) (range)−2.72 (2.59) (−3.60; −1.85)−2.47 (3.05) (−2.89; −2.04)0.66−0.257 (−1.310; 0.848)
    NRSBack % change n = 36 n = 200
     Mean (SD) (range)−46.5 (47.8) (−62.7; −30.3)−32.1 (108.1) (−47.1; −17.0)0.47−14.4 (−57.0; 14.6)
    ODI (1 y) n = 64 n = 225
     Mean (SD) (range)17.3 (16.7) (13.2; 21.5)15.6 (14.7) (13.7; 17.6)0.461.67 (−2.79; 5.89)
    1-y ODI decrease n = 41 n = 223
     Mean (SD) (range)−28.4 (19.2) (−34.5; −22.3)−28.7 (18.9) (−31.2; −26.2)0.920.336 (−5.833; 6.645)
    ODI % change n = 41 n = 223
     Mean (SD) (range)−61.7 (38.6) (−73.9; −49.5)−62.9 (35.1) (−67.6; −58.3)0.841.22 (−11.43; 13.17)
    EQ-VAS (1 y) n = 64 n = 218
     Mean (SD) (range)72.1 (19.1) (67.3; 76.8)76.4 (16.9) (74.2; 78.7)0.095−4.35 (−9.14; 0.65)
    EQ-VAS increase n = 42 n = 208
     Mean (SD) (range)28.1 (21.5) (21.4; 34.8)27.1 (25.2) (23.6; 30.5)0.801.03 (−6.71; 9.38)
    EQ-VAS % change n = 42 n = 205
     Mean (SD) (range)98.3 (121.3) (60.5; 136.1)98.6 (160.9) (76.4; 120.7)0.96−0.284 (−56.365; 43.688)
    GALeg
     GALeg 1–2a 42 (71.2%)183 (81.3%)−10.1 (−23.8; 3.6)
     GALeg 3–5b 17 (28.8%)42 (18.7%)0.1310.1 (−3.6; 23.8)
    GABack
     GABack 1–2a 44 (80.0%)154 (76.6%)3.4 (−9.9; 16.6)
     GABack 3–5b 11 (20.0%)47 (23.4%)0.74−3.4 (−16.6; 9.9)
    • Abbreviations: FELD, full-endoscopic lumbar discectomy; GA, global assessment; NRS, Numerical Rating Scale; ODI, Oswestry Disability Index.

    • GA was measured using a 5-level Likert-scale patient recall question.

    • ↵a GA values 1–2 = pain free and much better.

    • ↵b GA values 3–5 = better, somewhat better, and worse.

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    Table 4

    Attained PASS scores for the groups.

    PASS ScoresTotal (N = 480)FELD Group (n = 80)Control Group (n = 400) P ValueDifference Between Groups, Mean (95% CI)
    NRSLeg ≤2, n (%)
     No91 (31.4%)28 (41.8%)63 (28.3%)13.5 (−0.6; 27.7)
     Yes199 (68.6%)39 (58.2%)160 (71.7%)0.055−13.5 (−27.7; 0.6)
     Missing19013177
    NRSBack ≤2, n (%)
     No112 (39.2%)28 (45.2%)84 (37.5%)7.7 (−7.3; 22.6)
     Yes174 (60.8%)34 (54.8%)140 (62.5%)0.34−7.7 (−22.6; 7.3)
     Missing19418176
    Oswestry Disability Index ≤22, n (%)
     No72 (24.9%)18 (28.1%)54 (24.0%)4.1 (−9.2; 17.5)
     Yes217 (75.1%)46 (71.9%)171 (76.0%)0.60−4.1 (−17.5; 9.2)
     Missing19116175
    • Abbreviations: FELD, full-endoscopic lumbar discectomy; NRS, Numerical Rating Scale; PASS, patient acceptable symptom state.

    • View popup
    Table 5

    MIC values for the different surgical groups.

    MICFELD Group (n = 80)Control Group (n = 400) P ValueDifference Between Groups, Mean (95% CI)
    NRSLeg change ≥3.5, n (%)
     No17 (39.5%)58 (26.4%)13.2 (−3.9; 30.3)
     Yes26 (60.5%)162 (73.6%)0.12−13.2 (−30.3; 3.9)
     Missing37180
    NRSBack change ≥2.5, n (%)
     No23 (59.0%)125 (56.8%)2.2 (−16.1; 20.4)
     Yes16 (41.0%)95 (43.2%)0.94−2.2 (−20.4; 16.1)
     Missing41180
    Oswestry Disability Index change ≤20, n (%)
     No26 (63.4%)148 (66.4%)−3.0 (−20.4; 14.5)
     Yes15 (36.6%)75 (33.6%)0.843.0 (−14.5; 20.4)
     Missing39177
    • Abbreviations: FELD, full endoscopic lumbar discectomy; MIC, minimal important change; NRS, Numerical Rating Scale.

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Full-Endoscopic Lumbar Discectomy vs Standard Discectomy: A Noninferiority Study on Clinically Relevant Changes
Joel Beck, Olof Westin, Mikael Klingenstierna, Adad Baranto
International Journal of Spine Surgery Jun 2023, 17 (3) 364-369; DOI: 10.14444/8458

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Full-Endoscopic Lumbar Discectomy vs Standard Discectomy: A Noninferiority Study on Clinically Relevant Changes
Joel Beck, Olof Westin, Mikael Klingenstierna, Adad Baranto
International Journal of Spine Surgery Jun 2023, 17 (3) 364-369; DOI: 10.14444/8458
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