Comparison of 2 Postoperative Therapy Regimens After Trapeziectomy Due to Osteoarthritis: A Randomized, Controlled Trial.

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 (1-10, where 1 = 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. RESULTS: Of 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 = 28) compared with the control group (n = 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. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic II.

Task shifting in the care for patients with hand osteoarthritis. Protocol for a randomized controlled non-inferiority trial.

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: 1. What are the characteristics of patients with hand OA referred to specialist health care with regards to joint affection, disease activity, symptoms and function? 2. 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? 3. Is OT-led hand OA care equal to, or more cost effective than rheumatologist-led care? 4. 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.