Purpose The main aim of the present study was to evaluate whether early mobilization after trapeziectomy in the first carpometacarpal joint is noninferior to a postoperative regimen comprising the use of a rigid orthosis and mobilization after 6 weeks, with regards to patient-reported activity performance and the effect of surgery in patients with first carpometacarpal osteoarthritis.Methods In this prospective, randomized, controlled noninferiority trial, participants were assessed at baseline (before group allocation) and at 3, 6, and 12 months after surgery. The primary outcomes were activity performance, measured using the Canadian Occupational Performance Measure (1e10, where 1 ¼ unable to perform), and the patient-reported effect of surgery on a 6-point scale ranging from "much worse" to "completely recovered." A change of 2.0 points in the Canadian Occupational Performance Measure was used as a noninferiority margin. Secondary outcomes included hand function (patient-reported in the Measure of Activity Performance of the Hand questionnaire), pain on a numeric rating scale, grip and pinch strengths, and joint mobility. We performed both intention-to-treat and per-protocol analyses. ResultsOf the 59 participants (88% women) with a mean age of 65 years, 55 (93%) completed all assessments. We found no differences between the groups in primary or secondary outcomes at any time point, except for more decreased pain at rest in the intervention group (n ¼ 28) compared with the control group (n ¼ 27) after 12 months. The per-protocol analyses did not change these results. Fifteen participants experienced 1 or more adverse events during the first 3 months, but the types and frequencies of adverse events were similar between the 2 groups.Conclusions A postoperative regimen with early mobilization after trapeziectomy is as safe and effective as a postoperative regimen with longer immobilization in patients with first carpometacarpal osteoarthritis.

Background Current health policy states that patients with osteoarthritis (OA) should mainly be managed in primary health care. Still, research shows that patients with hand OA have poor access to recommended treatment in primary care, and in Norway, they are increasingly referred to rheumatologist consultations in specialist care. In this randomized controlled non-inferiority trial, we will test if a new model, where patients referred to consultation in specialist health care receive their first consultation by an occupational therapy (OT) specialist, is as safe and effective as the traditional model, where they receive their first consultation by a rheumatologist. More specifically, we will answer the following questions: What are the characteristics of patients with hand OA referred to specialist health care with regards to joint affection, disease activity, symptoms and function? Is OT-led hand OA care as effective and safe as rheumatologist-led care with respect to treatment response, disease activity, symptoms, function and patient satisfaction? Is OT-led hand OA care equal to, or more cost effective than rheumatologist-led care? Which factors, regardless of hand OA care, predict improvement 6 and 12 months after baseline? Methods Participants will be patients with hand OA diagnosed by a general practitioner and referred for consultation at one of two Norwegian departments of rheumatology. Those who agree will attend a clinical assessment and report their symptoms and function in validated outcome measures, before they are randomly selected to receive their first consultation by an OT specialist (n = 200) or by a rheumatologist (n = 200). OTs may refer patients to a rheumatologist consultation and vice versa. The primary outcome will be the number of patients classified as OMERACT/OARSI-responders after six months. Secondary outcomes are pain, function and satisfaction with care over the twelve-month trial period. The analysis of the primary outcome will be done by logistic regression. A two-sided 95% confidence interval for the difference in response probability will be formed, and non-inferiority of OT-led care will be claimed if the upper endpoint of this interval does not exceed 15%. Discussion The findings will improve access to evidence-based management of people with hand OA. Trial registration ClinicalTrials.gov, NCT03102788. Registered April 6th, 2017, https://clinicaltrials.gov/ct2/show/NCT03102788?term=Kjeken&draw=2&rank=1 Date and version identifier: December 17th, 2020. First version.

BackgroundHand-osteoarthritis (HOA) is a prevalent rheumatic joint disease that significantly reduces quality of life. In Norway, HOA should mainly be managed in primary care, but patients often have insufficient access to recommended treatment options there and are instead frequently referred to rheumatologists. This leads to high healthcare costs and reduces the access to rheumatologists for patients with inflammatory rheumatic diseases, for whom early diagnosis, disease modifying medication and tight controls may induce remission and prevent irreversible joint damage and long-term disability. Delegating the healthcare management and treatment of HOA to allied health professions such as occupational therapists may therefore free scarce healthcare resources and improve overall health economics.ObjectivesIn this study we evaluated a new model of care in specialist healthcare, where HOA patients receive their first consultation by occupational therapists instead of rheumatologists. The objective was to test the non-inferiority of occupational therapist-led care (OTC) compared to rheumatologist-led care (RC) with regards to effectiveness defined as proportion of responders (based on OMERACT/OARSI criteria) and safety. In addition, we conducted a health economics evaluation comparing Quality-adjusted life years (QUALYs) and treatment costs between the treatment groups and conducted a cost-economics analysis.MethodsWe conducted a randomized controlled multicentre parallel group trial in which we recruited 400 patients with symptomatic HOA and no signs of possible inflammatory rheumatic disease at two Norwegian hospitals. Participants were randomized (1:1, computer-based) to either OTC (n=200) or RC (n=200). Various demographic and clinical parameters were registered at baseline. Disease activity (numeric rating scale, NRS, 0-10, 0=no disease activity), pain (NRS, 0-10, 0=no pain) and function (using the MAP-hand questionnaire, 18 items averaged to a 1-4 score, 1=no problems) were registered at baseline and 6 months post-intervention, and the delta was used to determine if patients were responders/non-responders based on OMERACT/OARSI criteria. Chi2-test and logistic regression were used to compare the proportion of responders/non-responder per treatment arm, and to analyse the relationship between response status (as dependent variable) and treatment arm (as independent variables). Results of the logistic regression are presented as odds ratio (OR) with 95% confidence interval (CI). Safety analysis was conducted by screening healthcare journals 12 months post-baseline for new diagnoses and adverse events related to musculoskeletal diseases. QUALYs were calculated using data from EQ-5D weighted with preference weights from the general population. To evaluate cost-effectiveness, we calculated and compared the incremental cost-effectiveness ratio (ICER).ResultsMean age was 63.6 years (SD=10.01), 80.8 % were female. No statistical difference between the treatment arms was found in any baseline variables. In the RC group, 48 patients (25.8%) met the primary outcome criteria for treatment response. In the OTC group, also 48 (25.4%) were classified as responders. The proportion of responders did not differ by treatment group (X2 (1, N = 337) = 0.0012, p =.97). Treatment group did not significantly predict response status (OR=0.99, CI=0.62-1.59, p = 0.97). No notable safety-related events were found in either group. No statistically significant differences were found regarding QUALYs and overall treatment costs, and cost-effectiveness was marginal.ConclusionWe found no statistically significant difference regarding proportion of treatment responders between the two treatment arms, suggesting non-inferiority of OTC compared to RC with regards to effectiveness and safety. While the cost-effectiveness analysis showed no clear benefit for either of the treatment options, delegating HOA treatment to OTs may free RT time and improve healthcare accessibility for urgent diagnoses, and thus prove a valuable opportunity to optimize future healthcare allocation.REFERENCES:NIL.Acknowledgements:NIL.Disclosure of InterestsNone Declared.