| 1. |
- Brandt, Jonathan, et al.
(författare)
-
Single postoperative infusion of zoledronic acid to improve patient-reported outcome after hip or knee replacement : study protocol for a randomised, controlled, double-blinded clinical trial
- 2020
-
Ingår i: BMJ Open. - : BMJ. - 2044-6055. ; 10:9
-
Tidskriftsartikel (refereegranskat)abstract
- INTRODUCTION: In Sweden, roughly 3000 patients are reoperated each year due to pain and loss of function related to a loosened hip or knee prosthesis. These reoperations are strenuous for the patient, technically demanding and costly for the healthcare system. Any such reoperation that can be prevented would be of great benefit. Bisphosphonates are drugs that inhibit osteoclast function. Several clinical trials suggest that bisphosphonates lead to improved implant fixation and one small study even indicates better functional outcome. Furthermore, in epidemiological studies, bisphosphonates have been shown to decrease the rate of revision for aseptic loosening by half. Thus, there are several indirect indications that bisphosphonates could improve patient-reported outcome, but no firm evidence. METHODS AND ANALYSIS: This is a pragmatic randomised, placebo-controlled, double-blinded, academic clinical trial of a single postoperative dose of zoledronic acid, in patients younger than 80 years undergoing primary total hip or knee replacement for osteoarthritis. Participants will be recruited from two orthopaedic departments. All surgeries will be performed, and study drugs given at Motala Hospital, Sweden. The primary endpoint is to investigate between-group differences in the Hip dysfunction and Osteoarthritis Outcome Score and the Knee injury and Osteoarthritis Outcome Score at 3-year follow-up. Secondary outcomes will be investigated at 1 year, 3 years and 6 years, and stratified for hip and knee implants. These secondary endpoints are supportive, exploratory or explanatory. A total of 1000 patients will be included in the study. ETHICS AND DISSEMINATION: The study has been approved by the Regional Ethical Review Board in Linköping (DNR 2015/286-31). The study will be reported in accordance with the Consolidated Standards of Reporting Trials statement for pharmacological trials. The results will be submitted for publication in peer-reviewed academic journals and disseminated to patient organisations and the media. TRIAL REGISTRATION NUMBER: EudraCT: No 2015-001200-55; Pre-results.
|
|
| 2. |
- Dell'Isola, Andrea, et al.
(författare)
-
Education, Home Exercise, and Supervised Exercise for People With Hip and Knee Osteoarthritis As Part of a Nationwide Implementation Program : Data From the Better Management of Patients With Osteoarthritis Registry
- 2020
-
Ingår i: Arthritis Care and Research. - : Wiley. - 2151-464X .- 2151-4658. ; 72:2, s. 201-207
-
Tidskriftsartikel (refereegranskat)abstract
- Objective: To compare the effectiveness of education (ED) plus home exercise (HE) and ED plus supervised exercise (SE) according to information provided by the Better Management of Patients With Osteoarthritis (BOA) Registry, a nationally implemented rehabilitation program for patients with hip and knee osteoarthritis (OA). In addition, we investigated whether or not the effect of the treatments differed based on the joint affected by OA (hip versus knee). Methods: We included 38,030 participants from the BOA Registry with knee or hip OA who were treated with either ED, HE, or SE. The effect of the 3 treatment options on the pain intensity reduction (range 0–10) immediately postintervention and at 12 months was estimated using a mixed-effects model adjusted for age, sex, body mass index, affected joint (hip or knee), pain at baseline, comorbidity, and level of education. Results: The participants undergoing HE or SE experienced a greater pain reduction compared to participants who received ED, both after the treatment (group mean change for ED –0.91 [95% confidence interval (95% CI) –1.15, –0.68], for HE –1.06 [95% CI –1.10, –1.01], and for SE –1.12 [95% CI –1.15, –1.08]) and at 12 months (group mean change for ED –0.58 [95% CI –0.87, –0.30], for HE –0.82 [95% CI –0.87, –0.76], and for SE –0.82 [95% CI –0.86, –0.77]). Patients with knee OA who underwent HE or SE improved more compared to patients with hip OA at both follow-ups. Conclusion: In primary care, HE and SE lead to similar reductions in pain intensity but are more effective than ED alone. In addition, people with knee OA benefit more from HE and SE than people with hip OA.
|
|
| 3. |
- Tommiska, Pihla, et al.
(författare)
-
Finnish study of intraoperative irrigation versus drain alone after evacuation of chronic subdural haematoma (FINISH) : a study protocol for a multicentre randomised controlled trial
- 2020
-
Ingår i: BMJ Open. - : BMJ. - 2044-6055. ; 10:6, s. 038275-038275
-
Tidskriftsartikel (refereegranskat)abstract
- INTRODUCTION: Chronic subdural haematomas (CSDHs) are one of the most common neurosurgical conditions. The goal of surgery is to alleviate symptoms and minimise the risk of symptomatic recurrences. In the past, reoperation rates as high as 20%-30% were described for CSDH recurrences. However, following the introduction of subdural drainage, reoperation rates dropped to approximately 10%. The standard surgical technique includes burr-hole craniostomy, followed by intraoperative irrigation and placement of subdural drainage. Yet, the role of intraoperative irrigation has not been established. If there is no difference in recurrence rates between intraoperative irrigation and no irrigation, CSDH surgery could be carried out faster and more safely by omitting the step of irrigation. The aim of this multicentre randomised controlled trial is to study whether no intraoperative irrigation and subdural drainage results in non-inferior outcome compared with intraoperative irrigation and subdural drainage following burr-hole craniostomy of CSDH. METHODS AND ANALYSIS: This is a prospective, randomised, controlled, parallel group, non-inferiority multicentre trial comparing single burr-hole evacuation of CSDH with intraoperative irrigation and evacuation of CSDH without irrigation. In both groups, a passive subdural drain is used for 48 hours as a standard of treatment. The primary outcome is symptomatic CSDH recurrence requiring reoperation within 6 months. The predefined non-inferiority margin for the primary outcome is 7.5%. To achieve a 2.5% level of significance and 80% power, we will randomise 270 patients per group. Secondary outcomes include modified Rankin Scale, rate of mortality, duration of operation, length of hospital stay, adverse events and change in volume of CSDH. ETHICS AND DISSEMINATION: The study was approved by the institutional review board of the Helsinki and Uusimaa Hospital District (HUS/3035/2019 §238) and duly registered at ClinicalTrials.gov. We will disseminate the findings of this study through peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: NCT04203550.
|
|
