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.

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).

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.

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.