Post-operative Pain and QoL Article Plus Web Appendices Supplemental Digital Material Table 1. Patient and treatment characteristics of studies reporting postoperative pain and QoL following surgery for LBP. Author (year) Becker1 (2010) Berg2 (2009) Study design (LoE) Follow-up (% followed) Retrospective cohort 2 years (82%) RCT 2 years (100%) Demographics N = 239 Male: NR Mean age (± SD): 76 ± 4.0 years (70–89) Total N = 152 Male: 41% Mean age (± SD): 39 ± 8.0 years TDR N = 80 Male: 40% Mean age (± SD): 40 ± 8.1 years Fusion N = 72 Male: 42% Mean age (± SD): 39 ± 7.8 years Patient characteristics • Aged 70–89 • Preoperative diagnoses: spinal Interventions • Fusion with pedicle screws stenosis, spondylolisthesis, osteochondrosis, and degenerative scoliosis • ASA class I (9%), class II (69%), and class III (22%) • • Smokers • Total: 11% TDR: 10% Fusion: 11% • Previous spinal surgery Total: 12% TDR: 12% Fusion: 11% • LBP ≥ 2 years Total: 83% TDR: 79% Fusion: 87% • • • 1 and rod instrumentation with or without intervertebral cages introduced by PLIF Average number of fused levels was 1.7 ± 1.2 (range, 1–7) Postoperative management included early included early mobilization without a brace on day 1 TDR with 1 of 3 devices: Charité, Prodisc or Maverick Fusion instrumented from a posterior approach - either PLF (n = 44) or PLIF (n = 28) per surgeon preference 1-level surgery Total: 51% TDR: 56% Fusion: 46% Inclusion/Exclusion • Patients older than 70 years who underwent spinal fusion surgery in the period from 2002 to 2005 Included • LBP with or without leg pain for more than 1 year; if leg pain, back pain should dominate • Failed conservative treatment of > 3 months • Confirmation of disc degeneration on MRI • Age 20–55 years • ODI over 30 or back pain (VAS) over 50/100 the week before inclusion • Open mind to treatment options Excluded • Spinal stenosis requiring compression • Moderate or worse facet joint arthritis • 3+ painful levels at clinical exam • No obvious painful level, or levels, at diagnostic injection evaluation • Isthmic spondylolisthesis/olisthesis • Degenerative spondylolisthesis > 3 mm • Major deformity • Manifest osteoporosis • Previous lumbar fusion or decompression with postoperative instability Post-operative Pain and QoL Author (year) Study design (LoE) Follow-up (% followed) Demographics Patient characteristics Interventions Inclusion/Exclusion • • • • Carreon3 (2009) Prospective longitudinal cohort 2 years (90%) N = 546 Male: 39% Mean age (± SD): 56 ± 13 years (18–87) • • • • • • • • • • • • • Jenis6 (2006) Prospective cohort 2 years (97%) AGF N = 15 Male: 67% Mean age (± SD): 40 ± 7.5 years (30–52) • Autograft N = 22 Male: 64% Mean age (± SD): 41 ± 8.0 years (28–58) • • • Workers’ compensation: 6% Current smokers: 20% Disc pathology: 13% Scoliosis: 5% Spondylolisthesis: 23% Stenosis: 13% Instability: 5% Nonunion: 9% Postdecompression instability: 22% Adjacent level degeneration: 10% Equal back and leg pain: 42% Back pain more severe than leg pain: 25% Leg pain more severe than back pain: 33% Nicotine use AGF: 40% Autograft: 23% Previous discectomy AGF: 0 Autograft: 0.5% Workers’ compensation AGF: 60% Autograft: 68% Preoperative VAS AGF: 7.5 ± 1.1 (4–8) Autograft: 7.7 ± 1.7 (4–10) • Posterolateral fusion (76%) • Combined anteroposterior fusion (12%) • Transforaminal interbody fusion (9%) • Anterior interbody fusion (3%) • Number of levels fused 1-level: 45% 2-level: 30% 3+ levels: 25% • Anterior retroperitoneal • • • • 2 Compromised vertebral body Previous spinal infection or tumor Inability to understand information Language difficulties with inability to understand follow-up instruments • Pregnancy or other medical condition that would be a contraindication to surgery • Undergoing lumbar fusion for degenerative disorders from January 2001 to December 2005 approach to fusion; radical discectomy with preservation of peripheral cortical end plates Postoperative management included pain control via IV narcotics, early mobilization, home exercises, and avoidance of nonsteroidal anti-inflammatory agents Total levels operated AGF, n = 25 Autograft, n = 32 1-level AGF: 33% Autograft: 55% 2-levels AGF: 67% Autograft: 45% • Candidates for anterior-posterior lumbar fusion with diagnosis of degenerative disc disease and/or up to grade I spondylolytic spondylolisthesis based on positive provocative discography Post-operative Pain and QoL McKenna7 (2005) RCT 2 years (100%) FRA N = 37 Male: 46% Mean age: 39 years (24–53) • Previous • Circumferential fusion using Included: • DDD from L3 to S1 Single-center • Maximum of 2 consecutive motion • segments to be fused • Pain/functional deficit present ≥ 6 months • Failure to respond to conservative Titanium cage • treatment of ≥ 3 months N = 41 • Osteophyte formation Male: 44% • Sclerosis Mean age: 41 years • Facet joint degeneration (29–65) • ≥ 50% loss of intervertebral disc height • • 3.5 mm movement on flexion-extension radiographs • Disc dehydration ± reactive changes in • vertebral body endplate (MRI criteria) • Abnormal morphology at target level; concordant pain reproduction at target level (Provocative discography criteria) Excluded: • Age < 18 or > 70 years • Previous spinal fusion • ≥ grade II spondylolisthesis • >2 motion segments to be fused • Systematic infection • Active malignancy • Known osteoporosis AGF = autologous growth factors; ASA = American Society of Anesthesiologists; DDD = degenerative disc disease; FRA = femoral ring allograft; LBP = low back pain; NR = not reported; MRI = magnetic resonance imaging; ODI = Oswestry Disability Index; SD = standard deviation; TDR = total disc replacement; TED = thrombo-embolic deterrent; VAS = visual analog scale. discectomy/decompression FRA: 11% Titanium cage: 15% • Smoking FRA: 27% Titanium cage: 24% 3 femoral ring allografts or titanium cages Lumbar spine exposed anteriorly via a retroperitoneal approach Postoperative management included antibiotics, TED stockings for 6 weeks, and mobilization the day after surgery 1-level fused FRA: 59% Titanium cage: 54% 2-levels fused FRA: 41% Titanium cage: 46% Post-operative Pain and QoL Table 2. Results of included studies evaluating the relationship between postop pain and QoL following surgery for low back pain. Author (year) Becker (2010) Berg (2009) Study Design Follow-up (% followed) Caseseries 2 years (82%) RCT 2 years (100%) Pain and QoL measures VAS (10 mm) for back and leg pain SF-36 PCS and MCS VAS (100 mm) for back and leg pain Mean baseline scores Pain Back: 6.0 ± 2.5 Leg: 5.6 ± 2.8 QoL PCS: 28.2 ± 6.6 MCS: 37.8 ± 12.4 Fusion Back: 58.5 ± 21.7 Leg: 43.7 ± 28.2 Fusion 0.36 ± 0.27 TDR Back: 62.3 ± 20.8 Leg: 32.8 ± 26.4 TDR 0.42 ± 0.31 ODI 53.1 ± 18.2 Fusion 41.2 ± 14.6 EQ5D TDR 41.8 ± 11.8 Mean change scores Pain 1 year* Back: -2.7 Leg: -2.8 QoL 2 years* PCS: 4.7 MCS: 3.0 ODI 2 years* 13.8 2 years* Back: -1.7 Leg: -2.2 Fusion 1 year Back: -25.1 ± 34.2 Leg: -23.1 ± 32.7 Fusion 1 year 0.33 ± 0.38 Fusion 1 year 16.3 ± 18.4 2 years 0.33 ± 0.38 2 years 18.2† TDR 1 year 0.25 ± 0.36 TDR 1 year 22.4 ± 17.8 2 years 0.25 ± 0.36 2 years 21.9 ± 18.9 2 years Back: -29.3 ± 31.6 Leg: -23.2 ± 28.1 TDR 1 year Back: -36.8 ± 30.0 Leg: -19.6 ± 32.1 2 years Back: -36.9 ± 31.0 Leg: -21.0 ± 26.4 4 Questionnaires Randomized? No No Post-operative Pain and QoL Carreon (2009) Jenis (2006) Caseseries Pro cohort 2 years (90%) 2 years (97%) NRS (0-10) for back and leg pain SF-36 PCS and MCS VAS (10 mm) for back pain SF-36 PCS and MCS McKenna (2005) RCT 2 years (100%) Back: 7.7 ± 1.9 Leg: 7.3 ± 2.4 Total: PCS: 27.8 ± 6.3 MCS: 37.1 ± 13.4 53.2 ± 14.1 Back: -2.5 ± 2.84 Leg: -2.3 ± 3.4 Total: PCS: 4.6 ± 11.2 MCS: 2.8 ± 14.8 14.4 ± 17.8 No AGF 7.5 ± 1.1 AGF Total: PCS: 27.7 ± 5.9 MCS: 36.9 ± 7.9 AGF 59.5 ± 13.1 AGF -2.7 (4.8 ± 3.2) AGF Total: PCS: 6.4 (34.1 ± 11.1) MCS: 1.5 (38.4 ± 12.2) AGF 12.5 (47.0 ± 19.8) No Autograft 7.7 ± 1.7 VAS (10 mm) for back and leg pain FRA Back: 7.2 ± 1.7 Leg: 3.8 ± 2.7 SF-36 subscales TC Back: 7.1 ± 1.9 Leg: 4.3 ± 3.2 Autograft 60.0 ± 18.8 Autograft Total: PCS: 29.0 ± 6.5 MCS: 32.9 ± 10.2 FRA Total: 34.4§ FRA 57 ± 14 TC Total: 37.4§ TC 54 ± 14 Autograft -2.9 (4.8 ± 3.0) FRA 1 year Back: -2.4 Leg: -1.0 2 years Back:-2.0 Leg: -1.3 TC 1 year Back: -0.7 Leg: +0.3 Autograft Total: PCS: 9.1 (38.1 ± 11.6) MCS: 6.8 (39.7 ± 12.8) FRA 2 years Total: 11.4§ TC 2 years Total: 4.9§ Autograft 23.3 (36.7 ± 24.7) FRA 1 year: 18 No 2 years: 15 TC 1 year: 5 2 years: 6 2 years Back: -1.1 Leg: +0.4 AGF: autologous growth factors; FRA: femoral ring allograft; MCS: mental component score of SF-36; PCS: physical component score of SF-36; TC: titanium cage; TDR: total disc replacement. *Scores were calculated using the percent improvement provided in the text for each time point. †No standard deviation was available for the change score at 2 years due to a typo in the results table of the original paper. Change score only was able to be calculated from the pre and post scores given. §Total SF-36 score calculated by taking the average of the 8 subscale scores. 5