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Signe Elmose, Mikkel Ø. Andersen, Else Bay Andresen, and Leah Yacat Carreon

OBJECTIVE

The purpose of this study was to investigate the effect of tranexamic acid (TXA) compared to placebo in low-risk adult patients undergoing elective minor lumbar spine surgery—specifically with respect to operative time, estimated blood loss, and complications. Studies have shown that TXA reduces blood loss during major spine surgery. There have been no previous studies on the effect of TXA in minor lumbar spine surgery in which these variables have been evaluated.

METHODS

The authors enrolled patients with ASA grades 1 to 2 scheduled to undergo lumbar decompressive surgery at Middelfart Hospital into a double-blind, randomized, placebo-controlled, parallel-group study. Patients with thromboembolic disease, coagulopathy, hypersensitivity to TXA, or a history of convulsion were excluded. Patients were randomly assigned, in blocks of 10, to one of 2 groups, TXA or placebo. Anticoagulation therapy was discontinued 2–7 days preoperatively. Prior to the incision, patients received either a bolus of TXA (10 mg/kg) or an equivalent volume of saline solution (placebo). Independent t-tests were used to compare differences between the 2 groups, with statistical significance set at p < 0.05.

RESULTS

Of the 250 patients enrolled, 17 patients were excluded, leaving 233 cases for analysis (117 in the TXA group and 116 in the placebo group). The demographics of the 2 groups were similar, except for a higher proportion of women in the TXA group (TXA 50% vs placebo 32%, p = 0.017). There was no significant between-groups difference in operative time (49.53 ± 18.26 vs 54.74 ± 24.49 minutes for TXA and placebo, respectively; p = 0.108) or intraoperative blood loss (55.87 ± 48.48 vs 69.14 ± 83.47 ml for TXA and placebo, respectively; p = 0.702). Postoperative blood loss measured from drain output was 62% significantly lower in the TXA group (13.03 ± 21.82 ml) than in the placebo group (34.61 ± 44.38 ml) (p < 0.001). There was no significant difference in number of dural lesions or postoperative spinal epidural hematomas, and there were no thromboembolic events.

CONCLUSIONS

Tranexamic acid did not have a statistically significant effect on operative time, intraoperative blood loss, or complications. This study gives no evidence to support the routine use of TXA during minor lumbar decompressive surgery.

Clinical trial registration no.: NCT03714360 (clinicaltrials.gov)

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Rune T. Paulsen, Jan Sørensen, Leah Y. Carreon, and Mikkel Ø. Andersen

OBJECTIVE

The aim of this study was to examine whether routine referral to municipal postoperative rehabilitation is cost-effective in comparison to no referral after surgery for lumbar disc herniation (LDH).

METHODS

One hundred forty-six patients scheduled for primary discectomy due to LDH were included. This secondary analysis, based on data from a previous randomized controlled trial, compared costs and quality-adjusted life years (QALYs) between two groups of patients recovering from LDH surgery: one group of patients received a referral for municipal physical rehabilitation (REHAB) and the other group was sent home without a referral to any postoperative rehabilitation (HOME). Primary outcomes were QALYs calculated from the EQ-5D utility score, societal costs, and incremental cost-effectiveness ratios (ICERs). The main cost-effectiveness analysis used intention-to-treat data, whereas sensitivity analyses included as-treated data. Questionnaires were collected after 1, 3, 6, 12, and 24 months postoperatively.

RESULTS

The main cost-effectiveness analysis showed a small, insignificant incremental QALY of 0.021 and an incremental cost of €211.8 for the REHAB group compared to the HOME group, resulting in an ICER of €10,085. In the as-treated sensitivity analysis, the REHAB group had poorer outcomes and higher costs compared to the HOME group.

CONCLUSIONS

Routine referral to municipal physical rehabilitation in patients recovering from LDH surgery was not cost-effective compared to no referral.

Clinical trial registration no.: NCT03505918 (clinicaltrials.gov)

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Simon Thorbjørn Sørensen, Rachid Bech-Azeddine, Søren Fruensgaard, Mikkel Østerheden Andersen, and Leah Carreon

OBJECTIVE

Patients with lumbar disc herniation (LDH) typically present with lower-extremity radiculopathy. However, there are patients who have concomitant substantial back pain (BP) and are considered candidates for fusion. The purpose of this study was to determine if patients with LDH and substantial BP improve with discectomy alone.

METHODS

The DaneSpine database was used to identify 2399 patients with LDH and baseline BP visual analog scale (VAS) scores ≥ 50 who underwent a lumbar discectomy at one of 3 facilities between June 2010 and December 2017. Standard demographic and surgical variables and patient-reported outcomes, including BP and leg pain (LP) VAS scores (0–100), Oswestry Disability Index (ODI), and European Quality of Life–5 Dimensions Questionnaire (EQ-5D) at baseline and 12 months postoperatively, were collected.

RESULTS

A total of 1654 patients (69%) had 12-month data available, with a mean age of 48.7 years; 816 (49%) were male and the mean BMI was 27 kg/m2. At 12 months postoperatively, there were statistically significant improvements (p < 0.0001) in BP (72.6 to 36.9), LP (74.8 to 32.6), ODI (50.9 to 25.1), and EQ-5D (0.25 to 0.65) scores.

CONCLUSIONS

Patients with LDH and LP and concomitant substantial BP can be counseled to expect improvement in their BP 12 months after surgery after a discectomy alone, as well as improvement in their LP.

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Rachid Bech-Azeddine, Søren Fruensgaard, Mikkel Andersen, and Leah Y. Carreon

OBJECTIVE

The predominant symptom of lumbar spinal stenosis (LSS) is neurogenic claudication or radicular pain. Some surgeons believe that the presence of substantial back pain is an indication for fusion, and that decompression alone may lead to worsening of back pain from destabilization associated with facet resection. The purpose of this study was to determine if patients with LSS and clinically significant back pain could obtain substantial improvements in back pain after a decompression alone without fusion.

METHODS

The DaneSpine database was used to identify 2737 patients with LSS without segmental instability and a baseline back pain visual analog scale (VAS) score ≥ 50 who underwent a decompression procedure alone without fusion. Standard demographic and surgical variables and patient outcomes, including back and leg pain VAS score (0–100), Oswestry Disability Index (ODI), and EQ-5D at baseline and at 12 months postoperatively, were collected.

RESULTS

A total of 1891 patients (69%) had 12-month follow-up data available for analysis; the mean age was 66.4 years, 860 (46%) were male, the mean BMI was 27.8 kg/m2, and 508 (27%) were current smokers. At 12 months postoperatively, there were statistically significant improvements (p < 0.001) from baseline for back pain (72.1 to 42.1), leg pain (71.2 to 41.3), EQ-5D (0.35 to 0.61), and ODI (44.1 to 27.8).

CONCLUSIONS

Patients with LSS, clinically substantial back pain, and no structural instability obtain improvement in back pain after decompression-only surgery and do not need a concomitant fusion.