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1.
Trials ; 24(1): 229, 2023 Mar 25.
Artigo em Inglês | MEDLINE | ID: mdl-36966310

RESUMO

BACKGROUND: Rheumatoid arthritis (RA) and psoriatic arthritis (PsA) are inflammatory diseases that often affect the wrist and, when affected, can lead to impaired wrist function and progressive joint destruction if inadequately treated. Standard care consists primarily of disease-modifying anti-rheumatic drugs (DMARDs), often supported by systemic corticosteroids or intra-articular corticosteroid injections (IACSI). IACSI, despite their use worldwide, show poor response in a substantial group of patients. Arthroscopic synovectomy of the wrist is the surgical removal of synovitis with the goal to relieve pain and improve wrist function. The primary objective of this study is to evaluate wrist function following arthroscopic synovectomy compared to IACSI in therapy-resistant patients with rheumatoid or psoriatic arthritis. Secondary objectives include radiologic progress, disease activity, health-related quality of life, work participation and cost-effectiveness during a 1-year follow-up. METHODS: This protocol describes a prospective, randomized controlled trial. RA and PsA patients are eligible with prominent wrist synovitis objectified by a rheumatologist, not responding to at least 3 months of conventional DMARDs and naïve to biological DMARDs. For 90% power, an expected loss to follow-up of 5%, an expected difference in mean Patient-Rated Wrist Evaluation score (PRWE, range 0-100) of 11 and α = 0.05, a total sample size of 80 patients will be sufficient to detect an effect size. Patients are randomized in a 1:1 ratio for arthroscopic synovectomy with deposition of corticosteroids or for IACSI. Removed synovial tissue will be stored for an ancillary study on disease profiling. The primary outcome is wrist function, measured with the PRWE score after 3 months. Secondary outcomes include wrist mobility and grip strength, pain scores, DAS28, EQ-5D-5L, disease progression on ultrasound and radiographs, complications and secondary treatment. Additionally, a cost-effectiveness analysis will be performed, based on healthcare costs (iMCQ questionnaire) and productivity loss (iPCQ questionnaire). Follow-up will be scheduled at 3, 6 and 12 months. Patient burden is minimized by combining study visits with regular follow-ups. DISCUSSION: Persistent wrist arthritis continues to be a problem for patients with rheumatic joint disease leading to disability. This is the first randomized controlled trial to evaluate the effect, safety and feasibility of arthroscopic synovectomy of the wrist in these patients compared to IACSI. TRIAL REGISTRATION: Dutch trial registry (CCMO), NL74744.100.20. Registered on 30 November 2020. CLINICALTRIALS: gov NCT04755127. Registered after the start of inclusion on 15 February 2021.


Assuntos
Antirreumáticos , Artrite Psoriásica , Artrite Reumatoide , Sinovite , Humanos , Punho , Sinovectomia/efeitos adversos , Estudos Prospectivos , Qualidade de Vida , Artrite Psoriásica/diagnóstico , Artrite Psoriásica/tratamento farmacológico , Artrite Psoriásica/cirurgia , Artrite Reumatoide/diagnóstico , Artrite Reumatoide/tratamento farmacológico , Artrite Reumatoide/complicações , Sinovite/tratamento farmacológico , Antirreumáticos/efeitos adversos , Injeções Intra-Articulares/efeitos adversos , Dor/tratamento farmacológico , Resultado do Tratamento , Artroscopia/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto
2.
Injury ; 48(3): 731-737, 2017 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-28179058

RESUMO

INTRODUCTION: Malunion occurs in approximately 23% of non-operatively treated and 11% of operatively treated distal radius fractures. The decision whether to correct a malunion is primarily based on functional impairment and wrist pain. The purpose of this study was to assess the long-term functional outcomes of corrective osteotomies for symptomatic malunited distal radius fractures. METHODS: All consecutive corrective osteotomies of the distal radius performed in one centre between January 2009 and January 2016 were included. The primary outcome was the functional outcome assessed with the Disability of the Arm, Shoulder and Hand (DASH) and the Patient-Rated Wrist Evaluation (PRWE) score. Secondary outcomes were range of motion, grip strength, pain as indicated on the Visual Analogue Scale (VAS) before and after corrective osteotomy, radiological parameters, time to union and complications. Additionally, we aimed to determine if there were any difference in graft versus no graft usage. RESULTS: A total of 48 patients were included. The median age was 54.5 years (IQR 39-66) and 71% was female. The median time to follow-up was 27 months. The median DASH and PRWE score were respectively 10.0 (IQR 5.8-23.3) and 18.5. (6.5-37.0). Except for pronation and supination, range of motion and grip strength of the injured wrist were significantly less compared to the uninjured side. Palmar and dorsal flexion and radial and ulnar deviation of the injured wrist were significantly less compared with the uninjured side. VAS pain scores decreased significantly from 6.5 preoperative to 1.0 postoperative. The median time to union was 23 weeks (IQR 12-29.5). Eighteen patients (38%) had a complication for which additional treatment was required. Except for a significant difference in radial inclination and length after the corrective osteotomy in favour of graft usage, there were no significant differences between graft an no graft usage. CONCLUSIONS: Corrective osteotomy is an effective method of treating symptomatic distal radius malunions with good long-term functional results, measured with the DASH and PRWE score, and improvement in radiographic parameters and pain scores. Additionally, no differences in functional outcomes were found between graft and no graft usage.


Assuntos
Transplante Ósseo/métodos , Consolidação da Fratura/fisiologia , Fraturas Mal-Unidas/cirurgia , Osteotomia , Satisfação do Paciente/estatística & dados numéricos , Fraturas do Rádio/cirurgia , Articulação do Punho/fisiopatologia , Adulto , Avaliação da Deficiência , Feminino , Seguimentos , Fraturas Mal-Unidas/epidemiologia , Fraturas Mal-Unidas/fisiopatologia , Fraturas Mal-Unidas/psicologia , Humanos , Masculino , Pessoa de Meia-Idade , Países Baixos/epidemiologia , Osteotomia/métodos , Medição da Dor , Radiografia , Fraturas do Rádio/epidemiologia , Fraturas do Rádio/fisiopatologia , Fraturas do Rádio/psicologia , Amplitude de Movimento Articular/fisiologia , Recuperação de Função Fisiológica , Estudos Retrospectivos , Resultado do Tratamento
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