The appropriate management of persisting pain after spine surgery: a European panel study with recommendations based on the RAND/UCLA method.

PURPOSE: Management of patients with persisting pain after spine surgery (PPSS) shows significant variability, and there is limited evidence from clinical studies to support treatment choice in daily practice. This study aimed to develop patient-specific recommendations on the management of PPSS. METHODS: Using the RAND/UCLA appropriateness method (RUAM), an international panel of 6 neurosurgeons, 6 pain specialists, and 6 orthopaedic surgeons assessed the appropriateness of 4 treatment options (conservative, minimally invasive, neurostimulation, and re-operation) for 210 clinical scenarios. These scenarios were unique combinations of patient characteristics considered relevant to treatment choice. Appropriateness had to be expressed on a 9-point scale (1 = extremely inappropriate, 9 = extremely appropriate). A treatment was considered appropriate if the median score was ≥ 7 in the absence of disagreement (≥ 1/3 of ratings in each of the opposite sections 1-3 and 7-9). RESULTS: Appropriateness outcomes showed clear and specific patterns. In 48% of the scenarios, exclusively one of the 4 treatments was appropriate. Conservative treatment was usually considered appropriate for patients without clear anatomic abnormalities and for those with new pain differing from the original symptoms. Neurostimulation was considered appropriate in the case of (predominant) neuropathic leg pain in the absence of conditions that may require surgical intervention. Re-operation could be considered for patients with recurrent disc, spinal/foraminal stenosis, or spinal instability. CONCLUSIONS: Using the RUAM, an international multidisciplinary panel established criteria for appropriate treatment choice in patients with PPSS. These may be helpful to educate physicians and to improve consistency and quality of care. These slides can be retrieved under Electronic Supplementary Material.

Health-related quality of life in patients with surgically treated lumbar disc herniation: 2- and 7-year follow-up of 117 patients.

BACKGROUND AND PURPOSE: Health-related quality of life (HRQoL) instruments have been of increasing interest for evaluation of medical treatments over the past 10-15 years. In this prospective, long-term follow-up study we investigated the influence of preoperative factors and the change in HRQoL over time after lumbar disc herniation surgery. METHODS: 117 patients surgically treated for lumbar disc herniation (L4-L5 or L5-S1) were evaluated with a self-completion HRQoL instrument (EQ-5D) preoperatively, after 2 years (96 patients) and after 7 years (89 patients). Baseline data (age, sex, duration of leg pain, surgical level) and degree of leg and back pain (VAS) were obtained preoperatively. The mean age was 39 (18-66) years, 54% were men, and the surgical level was L5-S1 in 58% of the patients. The change in EQ-5D score at the 2-year follow-up was analyzed by testing for correlation and by using a multiple regression model including all baseline factors (age, sex, duration of pain, degree of leg and back pain, and baseline EQ-5D score) as potential predictors. RESULTS: 85% of the patients reported improvement in EQ-5D two years after surgery and this result remained at the long-term follow-up. The mean difference (change) between the preoperative EQ-5D score and the 2-year and 7-year scores was 0.59 (p < 0.001) and 0.62 (p < 0.001), respectively. However, the HRQoL for this patient group did not reach the mean level of previously reported values for a normal population of the same age range at any of the follow-ups. The changes in EQ-5D score between the 2- and 7-year follow-ups were not statistically significant (mean change 0.03, p = 0.2). There was a correlation between baseline leg pain and the change in EQ-5D at the 2-year (r = 0.33, p = 0.002) and 7-year follow-up (r = 0.23, p = 0.04). However, when using regression analysis the only statistically significant predictor for change in EQ-5D was baseline EQ-5D score. INTERPRETATION: Our findings suggest that HRQoL (as measured by EQ-5D) improved 2 years after lumbar disc herniation surgery, but there was no further improvement after 5 more years. Low quality of life and severe leg pain at baseline are important predictors of improvement in quality of life after lumbar disc herniation surgery.

Percutaneous Interspinous Spacer vs Decompression in Patients with Neurogenic Claudication: An Alternative in Selected Patients?

BACKGROUND: Standalone interspinous process devices (IPDs) to treat degenerative lumbar spinal stenosis with neurogenic intermittent claudication (NIC) have shown ambiguous results in the literature. OBJECTIVE: To show that a minimally invasive percutaneous IPD is safe and noninferior to standalone decompressive surgery (SDS) for patients with degenerative lumbar spinal stenosis with NIC. METHODS: A multicenter, international, randomized, controlled trial (RCT) was con- ducted. One hundred sixty-three patients, enrolled at 19 sites, were randomized 1:1 to treatment with IPD or SDS and were followed for 24 mo. RESULTS: There was significant improvement in Zurich Claudication Questionnaire physical function, as mean percentage change from baseline, for both the IPD and the SDS groups at 12 mo (primary endpoint) and 24 mo (-32.3 ± 32.1, -37.5 ± 22.8; and -37.9 ± 21.7%, -35.2 ± 22.8, both P < .001). IPD treatment was not significantly noninferior (margin: 10%) to SDS treatment at 12 mo (P = .172) but was significantly noninferior at 24 mo (P = .005). Symptom severity, patient satisfaction, visual analog scale leg pain, and SF-36 improved in both groups over time. IPD showed lower mean surgical time and mean blood loss (24 ± 11 min and 6 ± 11 mL) compared to SDS (70 ± 39 min and 189 ± 148 mL, both P < .001). Reoperations at index level occurred in 18.2% of the patients in the IPD group and in 9.3% in the SDS group. CONCLUSION: Confirming 3 recent RCTs, we could show that IPD as well as open decompression achieve similar results in relieving symptoms of NIC in highly selected patients. However, despite some advantages in secondary outcomes, a higher reoperation rate for IPD is confirmed.

Clinical application of a new three-dimensional radiological classification of lumbar disc herniations.

The results after lumbar discectomy are usually satisfactory. However, there is a group of patients with less favorable result. The predictive factors affecting the result are not fully understood. In this paper a new radiological classification for lumbar disc herniations has been used in order to study the predictive value of the type and location of the herniation for the postoperative result. 142 patients operated with standard lumbar discectomy were included in the study. The preoperative CT-scans were used to classify the disc herniations in the transverse, sagittal and longitudinal directions and the size of the herniations were calculated. At a mean of 7.7 years postoperatively a patient administrated questionnaire was used to compare the clinical results to the radiological findings. A significantly smaller size of the lumbar disc herniation was found with increasing age, which could reflect the increased degeneration of the disc. Patients with a wide transverse distribution of the herniation seem to have a less favorable postoperative outcome in terms of higher rate of repeat surgery (p = 0.056). No other correlations were found.

A radiostereometric analysis of the Bryan Cervical Disc prosthesis.

STUDY DESIGN: Prospective, radiostereometric study of the Bryan Cervical Disc prosthesis (Medtronic Sofamor Danek, Memphis, TN) for the treatment of a single-level disc disease of the cervical spine. OBJECTIVE: To study the stability of the titanium endplates of the disc prosthesis at the interface between the bone and prosthesis. SUMMARY OF BACKGROUND DATA: Cervical disc prosthesis is a motion-sparing technology in which the longevity is dependent on initial fixation as well as secondary fixation with bone ingrowth into the surface of the device. Little is known regarding the stability of this fixation with the currently studied prosthesis. METHODS: Eleven patients with symptomatic cervical radiculopathy underwent implantation of a radiostereometry modified Bryan prosthesis after a standard anterior cervical discectomy. The adjacent vertebrae were perioperatively marked with tantalum markers. The patients were then frequently studied with radiostereometric radiographs and evaluated for pain, and neurologic and physical function for 2 years. RESULTS: Both titanium endplates of the device were immediately stable in 5 patients. Small but measurable changes (micromotions) were recorded in 4 patients until the 3-month examination and in 2 patients at the 3-6-month time period. All prostheses continued to be stable after 6 months until the final assessment at 2 years after surgery. The recorded micromotions did not influence the clinical results. CONCLUSIONS: The Bryan prosthesis is immediately stable in many patients and is securely fixed to the bone within 3-6 months in all patients. The result of this study suggests that there is sufficient bone ingrowth on the coated surface of the Bryan prosthesis endplates to stabilize securely the prosthesis.

Autograft versus interbody fusion cage without plate fixation in the cervical spine: a randomized clinical study using radiostereometry.

A primary object with a fusion cage is avoidance of graft collapse with subsequent subsidence and malalignment of the cervical spine that is observed after bone grafting alone. No randomized studies exist that demonstrate the difference between these two methods in terms of graft subsidence and angulation of the fused segment. The size of the study population was calculated to be 24 patients to reach a significant difference at the 95% CI level. Patients with one-level cervical radiculopathy scheduled for surgery were randomized to anterior discectomy and fusion (ACDF) with autograft or to fusion cage, both without plate fixation. Tantalum markers were inserted in the two adjacent vertebrae at the end of surgery. Radiostereometry was performed immediately postoperatively and at regular intervals for 2 years. Questionnaires were used to evaluate the clinical outcome and an unbiased observer graded the outcome after 2 years. No significant differences were found between the two methods after 2 years in regard of narrowing of the disc space (mean 1.7 and 1.4 mm, respectively) or deformation of the fused segment into flexion (mean 7.7 degrees and 4.6 degrees , respectively). Patients in the cage group had a significantly better clinical outcome. The findings of subsidence and flexion deformation of the fused segment after 2 years seem to be of no clinical importance after one-level cervical disc surgery. However, in multi-level surgery using the same methods, an additive effect of the deformations of the fused segments may affect the clinical outcome.

Patients' satisfaction with provided care/information and expectations on clinical outcome after lumbar disc herniation surgery.

STUDY DESIGN: A prospective study of patients undergoing lumbar disc herniation surgery. OBJECTIVES: To assess patients' satisfaction with care/preoperative information, if expectations on surgical results and ability to return to work are related to baseline characteristics, and/or can predict self-reported outcome. Self-reported outcome was compared with objective outcome. SUMMARY OF BACKGROUND DATA: Patients' expectations on treatment results have been discussed as a predictive factor for postoperative outcome and satisfaction demonstrated to be directly related to patient expectations. METHODS: The study includes 148 patients, 46% women, mean age 40 (range 18-66). Before and 2 years after surgery, questionnaires about given information/care, expected/present work ability, and expectations on/obtained improvement of physical functions/symptoms (leg and back pain, sensibility, and muscle function) were filled in. The visual analog scale leg pain, Zung Depression Scale, and Oswestry Disability Index were used as baseline characteristics. At 2-year follow-up, self-reported and objective outcome was assessed. RESULTS: Satisfaction with given information/care were reported by 46% and 82%, respectively. Zung Depression Scale related to expectations on leg pain recovery (P = 0.022), work ability (P = 0.046), and satisfaction with given information (P = 0.031). Patients who expected to return (76%) and not return (24%) to work, returned in 78% and 26%, respectively (P = 0.021). A high agreement between self-reported outcome and objective outcome were found (P < 0.001). CONCLUSIONS: Patients undergoing lumbar disc herniation surgery are mostly satisfied with provided care before and after surgery, however, less satisfied with information provided. Further, patients with preoperative positive expectations on work return and realistic expectations on pain and physical recovery have a greater chance to be satisfied with the surgical results.

Comparing precision of distortion-compensated and stereophotogrammetric Roentgen analysis when monitoring fusion in the cervical spine.

Two methods to measure sagittal plane segmental motion in the cervical spine are compared. Translational and rotational motion was measured in nine cervical motion segments of nine patients by distortion-compensated (DCRA) as well as by stereophotogrammetric Roentgen analysis (RSA). To compare measurement precision of the new DCRA protocol with the established RSA technique under realistic clinical conditions and to discuss advantages and disadvantages of both methods in clinical studies. RSA constitutes the most precise method available to assess segmental motion or to monitor fusion in the cervical spine. Due to the invasive nature of the procedure there is an interest in alternative, non-invasive protocols, based on conventional, lateral radiographic views. In nine patients, segmental motion of nine cervical segments with spinal surgery and fusion had previously been assessed from stereo views by RSA. From the archive radiographs, sagittal plane segmental motion was re-assessed by DCRA. Results for sagittal plane translational and rotational motion obtained by both methods are compared. With respect to RSA, sagittal plane rotation was determined by DCRA with an error of 2.4 degrees and a mean difference not significantly different from zero. Sagittal plane translation was determined by DCRA with an error of less than 0.78 mm and a mean difference not significantly different from zero. As two methods are compared, these errors represent the combined (propagated) errors of RSA and DCRA. Averaged over the cohort investigated, measurement of sagittal plane segmental motion exhibited no significant difference between DCRA and RSA.

Mobility provocation radiostereometry in anterior cervical spine fusions.

This study aimed to evaluate the use of mobility-provocation radiostereometry (RSA) in anterior cervical spine fusions and compare the results to deformation studies on the same patients and plain flexion-extension radiographs. Mobility-provocation RSA was used to evaluate anterior cervical spine fusions in 45 patients. The motions recorded at 3 and 12 months postoperatively were compared to RSA measurements of deformation of the fusion over time and to plain flexion-extension radiographs in the same patients taken 3 months postoperatively. Studies of rotations from right to left revealed ten cases with significant motion at 3 months, and three at 12 months. With motion from flexion to extension, ten cases showed significant motion at 3 months and three at 12 months. In only three cases was the mobility-provocation RSA considered to add any information on the stability of the fusions compared to that obtained with the deformation studies. In 37 patients mobility-provocation radiography in flexion-extension using conventional technique was done to evaluate the accuracy. The mean difference between angular motions recorded on plain radiographs and rotations around the transverse axis in flexion to extension recorded with RSA was 1.6 degrees (range 0.04 degrees-8.04 degrees, SD 2.1 degrees). The corresponding 95% and 99% confidence limits for the difference between the two methods were 5.8 degrees and 7.2 degrees. The study showed that the use of mobility-provocation RSA did not add any information over that obtained by deformation RSA studies. Conventional radiography is too inaccurate to measure inducible displacement in this patient population.