Ceramic-on-Ceramic Total Hip Arthroplasty and Noises: A Prospective Blinded Randomized Controlled Trial of Influence of Component Design.

BACKGROUND: Noises have been associated with ceramic-on-ceramic bearings in total hip arthroplasties. The etiology is multifactorial, but a high prevalence of noises was reported in studies using a specific acetabular component system. We examined if specific ceramic component designs are associated with the prevalence of noises in 2 commonly used component systems. We hypothesized that there would be no difference in noises between the 2 systems. METHODS: In this randomized controlled trial, 2 different component designs with ceramic bearings were compared. Inclusion criteria were primary total hip arthroplasties, age between 18 and 65 years, and body mass index less than 35. The primary outcome was prevalence of noises, whereas secondary outcomes consisted of European Quality of Life index, visual analog scale, and University of California and Los Angeles activity scale. Follow-up data were collected at 3 and 12 months postoperatively. Data were available for 91 patients in Group 1 and for 92 patients in Group 2. Preoperative patient characteristics were comparable between groups. RESULTS: At 12-month follow-up, the prevalence of noises was 19% in Group 1 and 14% in Group 2 (P = .41). European Quality of Life index were 0.89 in Group 1 versus 0.90 in Group 2 (P = .42). The visual analog scale was 81 in both groups (P = .88). When evaluating level of activity, University of California and Los Angeles activity scale scores were 8.2 in both groups (P = .92). CONCLUSION: At 12-month follow-up, there was no difference in the prevalence of noises between the 2 component designs.

Are Modic Changes Associated With Health-related Quality of Life After Discectomy: A Study on 620 Patients With Two-year Follow-up.

STUDY DESIGN: A registry-based comparative cohort study with 2-year follow-up. OBJECTIVE: To assess whether Modic changes (MCs) are associated with health-related quality of life, long-term physical disability, back- or leg pain after discectomy. SUMMARY OF BACKGROUND DATA: Previous studies have failed to show a clinically significant association between MCs and patient-reported outcomes (PROs) after discectomy. METHODS: Data from the Danish National Spine Registry on patients undergoing first-time lumbar discectomy at a single institution from 2014 to 2017 with an accessible preoperative lumbar magnetic resonance imaging, complete preoperative, and 2-year follow-up questionnaires were obtained. PROs including Oswestry disability index (ODI), European Quality of Life-Five Dimensions (EQ-5D), visual analogue scale (VAS) back and leg pain, and patient satisfaction were collected. Patients were stratified based on the presence (+MC) or absence (-MC) of MCs on the preoperative MRI. RESULTS: Of 620 patients included, MCs were present in 290 patients (47%). Of these, MC type 1 (MC-1) was present in 73 (25%) and MC type 2 (MC-2) in 217 (75%) patients. Preoperative data for ODI, EQ-5D, VAS-BP, and VAS-LP were comparable for the +MC and -MC groups. Both groups had a statistically significant improvement in PROs from baseline compared with 2-year follow-up (P < 0.001). At 2-year follow-up, both groups had improved with no significant difference between them in regards to ODI (15.5 vs. 17.2, P = 0.208); EQ-5D (0.75 vs. 0.72, P = 0.167); VAS-BP (27.1 vs. 28.3, P = 0.617); VAS-LP (26.8 vs. 25.0, P = 0.446); and patient satisfaction (74% vs. 76%, P = 0.878). CONCLUSION: MCs were not found to be associated with health-related quality of life, disability, back- or leg pain, or patient satisfaction 2 years after discectomy. LEVEL OF EVIDENCE: 2.

Cost-effectiveness of postoperative rehabilitation after surgery for lumbar disc herniation: an analysis based on a randomized controlled trial.

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).

Return to work after surgery for lumbar disc herniation, secondary analyses from a randomized controlled trial comparing supervised rehabilitation versus home exercises.

BACKGROUND CONTEXT: Patients undergoing lumbar discectomy are typically referred for postoperative rehabilitation. However, evidence regarding effectiveness of postoperative rehabilitation to improve surgical outcome and hasten return to work is scarce with conflicting results in the published literature. PURPOSE: This study investigates the effect of postoperative rehabilitation on return to work, duration of sick leave and working ability after surgery for lumbar disc herniation. STUDY DESIGN/SETTING: Single center randomized controlled trial. PATIENT SAMPLE: Patients scheduled for primary discectomy due to lumbar disc herniation were included in the study. OUTCOME MEASURES: Self-reported measures included working ability, work status, and job type defined by the International Standard Classification of Occupations. All outcomes including duration of sick leave were obtained from follow-up questionnaires at 1 and 2 years after surgery. METHODS: This is a secondary analysis from a randomized controlled trial comparing patients who were referred to rehabilitation at the municipal facility starting 4-6 weeks postoperative (REHAB) and patients sent home after surgery without any planned rehabilitation course (HOME). Linear regression was performed to identify baseline characteristics associated with duration of sick leave. RESULTS: One hundred forty-six patients were included and equally distributed between the groups. Follow-up rate was 78% after 1 and 2 years. Both groups had a similar postoperative sick leave period of approximately 9 weeks. After 1 year 79% had returned to work in the HOME-group versus 74% in the REHAB-group, which was not statistically significant. Working ability improved from baseline to 1 year in both groups and this improvement was sustained at 2-year follow-up. Stepwise linear regression showed that preoperative duration of leg pain and working ability was associated with duration of postoperative sick leave. CONCLUSIONS: Referral for unstandardized municipal rehabilitation does not affect duration of postoperative sick leave, return to work or working ability in patients recovering after surgery for lumbar disc herniation. Duration of preoperative leg pain and preoperative working ability was significantly associated with the duration of postoperative sick leave.

Patient-reported Outcomes After Surgery for Lumbar Disc Herniation, a Randomized Controlled Trial Comparing the Effects of Referral to Municipal Physical Rehabilitation Versus No Referral.

STUDY DESIGN: Randomized controlled trial. OBJECTIVE: The aim of this study was to investigate the effect of referring patients to municipal physical rehabilitation compared to no referral on patient-reported outcomes (PROs) after surgery for lumbar disc herniation. SUMMARY OF BACKGROUND DATA: In surgical spine practice, lumbar discectomy is one of the most frequent interventions. Postoperatively, patients are typically referred to physical rehabilitation at the time of hospital discharge, and in Denmark all patients are legally entitled to a personal rehabilitation plan and referral for free rehabilitation at the municipal facilities. However, whether postoperative rehabilitation is effective in this group of patients remains controversial. METHODS: This single-center single blinded study randomized subjects into 2 groups. Patients in the REHAB group received municipal rehabilitation starting 4 to 6 weeks postoperative, whereas patients in the HOME group were discharged after surgery without any planned rehabilitation course. Primary outcome was Oswestry Disability Index after 6 months, whereas secondary outcomes included EuroQoL-5D and Visual Analogue Scale for leg and back pain. All PROs were obtained before surgery and at 1, 3 to 6, 12, and 24 months postoperative. RESULTS: A total of 146 patients were enrolled in the study: 73 allocated to the REHAB-group and 73 to the HOME-group. The groups were similar at baseline and the follow-up rate at 12 and 24 months was 78%. PROs in both groups improved significantly after surgery, but no statistically significant differences were observed between the groups at any follow-up time point in either the intent-to-treat, as-treated, and per-protocol analyses. Revision surgeries during the follow-up period were equally divided between the groups. CONCLUSION: Surgery for lumbar disc herniation is effective in relieving pain, improving function, and quality of life. The postoperative outcome is not altered significantly by referring patients to municipal physical rehabilitation compared to no referral. LEVEL OF EVIDENCE: 1.

A pilot cohort study of lumbar facet joint denervation in patients with chronic low-back pain.

INTRODUCTION: Radio-frequency (RF) denervation of the facet joints is a procedure aimed at the nociceptive median branch nerves of the lumbar dorsal rami. Pain signals from the facet joints are carried through these fibres; by ablating these fibres, central signalling can be prevented. This pilot study investigated the clinical effect and feasibility of the procedure at our institution, the Spine Centre of Southern Denmark. METHODS: Patients with at least 50% pain relief after initial medial branch diagnostic blocks were candidates for RF denervation. Patients were divided into two groups: 1) patients with at least 80% pain relief and 2) patients with between 50% and 79% pain relief after diagnostic blocks. Denervation was performed bilaterally on the three lowest facet joints in the lumbar spine. The primary outcome parameter was visual analogue scale (VAS). Follow-up questionnaires were answered after one week and after three, six and 12 months. RESULTS: For the whole sample, we found a mean reduction of 43 VAS points after one week. At three months, we found a mean reduction of 25 points. Six-month data showed a mean 19-point reduction. Twelve-month data showed a mean reduction of 17 points. Group 1 showed superior improvements at all follow-up points and after 12 months, we found a mean VAS reduction of 22 points for this group. CONCLUSIONS: This pilot cohort study found RF denervation of the facet joint to be a promising alternative for patients with chronic low-back pain. The effect persisted at the one-year follow-up; however, the effect diminished over time. FUNDING: The Danish Rheumatism Association, The A.P. Møller Foundation for the Advancement of Medical Science. TRIAL REGISTRATION: The study protocol was approved by the ethical committee of Southern Denmark with registration number S-20160070.

Patient-Reported Outcomes and Patient-Reported Satisfaction After Surgical Treatment for Cervical Radiculopathy.

STUDY DESIGN: Retrospective cohort study. OBJECTIVES: It is estimated that 10 000 patients seek medical care due to cervical radiculopathy every year in Denmark. Although the natural course is usually favorable, around 20% undergo surgery for cervical degenerative disease every year in Denmark. We aim to evaluate the patient-reported results and satisfaction of anterior cervical decompression and fusion over a 5-year period from a single Danish center for spine surgery. METHODS: This study is a retrospective study based on prospectively collected data from 318 consecutive patients treated with anterior cervical decompression and fusion over 1 to 3 levels. Data in the DaneSpine registry was collected pre- and postoperatively, and at 1 year after surgery. The outcome measures were Neck Disability Index (NDI), European Quality of Life 5D (EQ-5D), visual analogue score (VAS), and Short Form-36 Physical Component Summary (SF-36 PCS). RESULTS: Of 318 cases enrolled, 272 (85.5%) had follow-up data available at a minimum 1-year postoperatively. The mean preoperative NDI was 40.0 and improved to 22.7. Mean EQ-5D was 0.50 and improved to 0.70, and mean VAS arm was 60.4 improved to 26.4. All improvements were statistically significant. A total of 74.3% were back to work 1 year after surgery. Achieving minimal clinically important difference (MCID) in VAS neck and SF-36 PCS was strongly correlated to patient satisfaction. CONCLUSION: Patients who undergo anterior cervical discectomy and fusion can expect improvement in their pain and disability, with 74.3% of patients reporting a positive change in health status after surgery.

Prognostic Factors for Satisfaction After Decompression Surgery for Lumbar Spinal Stenosis.

BACKGROUND: Surgical treatment for lumbar spinal stenosis is associated with both short- and long-term benefits with improvements in patient function and pain. Even though most patients are satisfied postoperatively, some studies report that up to one-third of patients are dissatisfied. OBJECTIVE: To present clinical outcome data and identify prognostic factors related to patient satisfaction 1 yr after posterior decompression surgery for lumbar spinal stenosis. METHODS: This multicenter register study included 2562 patients. Patients were treated with various types of posterior decompression. Patients with previous spine surgery or concomitant fusion were excluded. Patient satisfaction was analyzed for associations with age, sex, body mass index, smoking status, duration of pain, number of decompressed vertebral levels, comorbidities, and patient-reported outcome measures, which were used to quantify the effect of the surgical intervention. RESULTS: At 1-yr follow-up, 62.4% of patients were satisfied but 15.1% reported dissatisfaction. The satisfied patients showed significantly greater improvement in all outcome measures compared to the dissatisfied patients. The outcome scores for the dissatisfied patients were relatively unchanged or worse compared to baseline. Association was seen between dissatisfaction, duration of leg pain, smoking status, and patient comorbidities. Patients with good walking capacity at baseline were less prone to be dissatisfied compared to patients with poor walking capacity. CONCLUSION: This study found smoking, long duration of leg pain, and cancerous and neurological disease to be associated with patient dissatisfaction, whereas good walking capacity at baseline was positively associated with satisfaction after 1 yr.

Patient-reported Outcomes and Revision Rates at a Mean Follow-up of 10 Years After Lumbar Total Disc Replacement.

STUDY DESIGN: Prospective observational cohort study. OBJECTIVE: The aim of this study was to determine the long-term clinical results and prosthesis survival in patients treated with lumbar total disc replacement (TDR). SUMMARY OF BACKGROUND DATA: Fusion has become the current standard surgical treatment for lumbar degenerative disease. TDR is an alternative treatment that seeks to avoid fusion-related adverse events, specifically adjacent segment disease. METHODS: Sixty-eight consecutive patients treated with TDR from 2003 to 2008 were invited to follow-up and complete a Visual Analog Scale (VAS) for back and leg pain, the Dallas Pain Questionnaire (DPQ), and the Short Form-36. These surveys were also administered to the subjects before their index TDRs. Data on reoperation were collected from the patients' medical records. RESULTS: Fifty-seven (84%) patients were available for follow-up at a mean 10.6 years post-operatively (range 8.1-12.6 years). There was a significant improvement from preop to latest follow-up in VAS (6.8 vs. 3.2, P < 0.000) and DPQ (63.2 vs. 45.6, P = 0.000) in the entire cohort. Nineteen patients (33%) had a revision fusion surgery after their index TDR. Patients who had revision surgery had statistically significant worse outcome scores at last follow-up than patients who had no revision. Thirty patients (52.6%) would choose the same treatment again if they were faced with the same problem. CONCLUSION: This study demonstrated significant improvement in long-term clinical outcomes, similar to previously published studies, and two-thirds of the discus prostheses were still functioning at follow-up. However, there is still a lack of well-designed long-term studies, thus requiring further investigation. LEVEL OF EVIDENCE: 3.

Patient are satisfied one year after decompression surgery for lumbar spinal stenosis.

INTRODUCTION: Lumbar spinal stenosis (LSS) is a clinical syndrome of buttock or lower extremity pain, which may occur with or without back pain. The syndrome is associated with diminished space available for the neural and vascular elements in the lumbar spine. LSS is typically seen in elderly patients, its prevalence is estimated to be 47% in people over the age 60 years. LSS is the most common reason for spine surgery in Denmark and the number of surgical procedures is likely to increase due to demographic changes. The purpose of this study was to evaluate the patient-reported outcomes and perioperative complications of spinal decompression surgery in LSS patients. METHODS: This study is a retrospective study based on prospectively collected data from 3,420 consecutive patients with clinical and magnetic resonance imaging confirmed LSS. Patients were treated with posterior decompression surgery without fusion. Data were obtained from the DaneSpine register and collected pre- and post-operatively after a minimum interval of one year. The outcome measures were Oswestry Disability Index (ODI), European Quality of Life 5D (EQ-5D), visual analogue score (VAS), 36-Short Form Mental Component Summary (MCS), 36-Short Form Physical Component Summary (PCS) and self-reported walking distance. RESULTS: Of 3,420 cases enrolled, 2,591 (75%) had complete data after a minimum interval of one year. The mean ODI scores were 39.8 and improved to 24. The mean EQ-5D score was 0.40 and improved to 0.66. The mean VAS-leg improved from 54 to 36. The mean VAS-back improved from 46 to 34. The mean MCS improved from 28 to 36, and, finally, the mean PCS improved from 40 to 45. All p-values were 0.0000. CONCLUSION: Surgery improved all the patient-reported outcome measures and 82% of patients were satisfied. FUNDING: none. TRIAL REGISTRATION: This study was registered with the Danish Data Protection Agency.

No differences in post-operative rehabilitation across municipalities in patients with lumbar disc herniation.

INTRODUCTION: Following the municipal reform in Denmark in January 2007, the municipalities gained responsibility for post-operative rehabilitation. In the Region of Southern Denmark, this task was decentralised to 22 municipalities, which implied a possible risk for considerable variation. This study examined rehabilitation in the 22 municipalities of the Region of Southern Denmark for patients with lumbar disk herniation. METHODS: A total of 22 physiotherapists answered a questionnaire regarding their rehabilitation programmes. The municipalities of 789 patients who had undergone decompressive surgery for lumbar disc herniation were identified. Changes in Oswestry disability index (ODI), EuroQol-5D (EQ-5D) and duration of sick leave were compared among the municipalities. RESULTS: Patient-reported outcome measures showed no statistical difference in ODI, EQ-5D or sick leave at the one-year follow-up across the 22 municipalities. There was a correlation between sick leave and outcome as a longer sick leave was associated with less improvement in EQ-5D and ODI. Rehabilitation programmes across the region were comparable with respect to several factors. The questionnaire revealed a potential for enhanced cooperation between hospitals and rehabilitation centres. CONCLUSION: Rehabilitation was broadly similar, and patient outcome after one year did not differ significantly across the 22 municipalities or between the five largest samples. In general, all municipalities request enhanced cooperation between hospital and rehabilitation unit to ensure the best possible patient treatment. Further studies should focus on the effect of rehabilitation. FUNDING: not relevant. TRIAL REGISTRATION: not relevant.