RESUMO
BACKGROUND: Calcific tendinitis of the shoulder (CT) is a common disorder with a large disease burden. The initial treatment is with conservative measures. However, when this fails the next step treatment remains unclear. Minimal invasive treatment modalities have emerged. Needle aspiration of the calcific deposits (NACD) and extracorporeal shock wave therapy (ESWT) have both shown good clinical results. Nonetheless, in the current orthopedic literature there are not any studies available that compare both the effectiveness and cost-effectiveness of those two treatment modalities. Therefore, our primary objective is to compare the effectiveness of NACD to ESWT. A secondary objective is to compare the cost-effectiveness of both treatment modalities and workability. METHODS: Following a power calculation using the minimal clinical important difference of our primary outcome (Constant-Murley score, CMS) 140 patients will be included in the study. Enrolment is based upon strict inclusion/ exclusion criteria outlined in the Methods section. Participants will be randomized by computer in two groups (e.g. 70 patients will receive NACD and 70 patients will receive ESWT). The NACD treatment will consist of a sonographically guided removal of the calcific deposits and the ESWT treatment will be a focused ESWT. Both treatments will be conducted according to a standardized protocol, as part of care as usual in our hospital. The primary outcome will be the between group differences in functional outcome (measured with the CMS) between baseline and after 12 months follow-up. Secondary outcomes will be questionnaires regarding the clinical outcome (SST) and quality of life (EQ-5D-5L). Furthermore, NRS pain and cost related questionnaires (iPCQ and ProDisQ) will be collected during follow-up after two months, six months and at final follow-up after 12 months. DISCUSSION: This study will provide more insight regarding treatment for conservative therapy resistant calcific tendinitis of the shoulder by comparing NACD to focused ESWT, which will aid the physician and patient in determining the appropriate treatment plan. TRIAL REGISTRATION: Dutch trial register: NTR7093 registered on 11 March 2018.
Assuntos
Calcinose , Tratamento por Ondas de Choque Extracorpóreas , Tendinopatia , Calcinose/complicações , Calcinose/diagnóstico por imagem , Calcinose/terapia , Tratamento Conservador , Humanos , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Ombro , Tendinopatia/complicações , Tendinopatia/diagnóstico por imagem , Tendinopatia/terapia , Resultado do TratamentoRESUMO
Purpose: Graft failure rates after anterior cruciate ligament reconstruction (ACLR) in children and adolescents are higher compared to adults. Anterolateral augmentation procedures have recently generated increased focus regarding their ability to reduce graft failure rates. Concerns in skeletally immatures are potential growth disturbances and overconstraint after anterolateral augmentation. The aim of this scoping review is to provide an overview of all current anterolateral augmentation procedures in skeletally immature patients and to discuss surgical techniques, clinical and biomechanical outcomes. Methods: This scoping review was performed following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) statement extension for scoping reviews. On 22 December 2022, an information specialist performed a systematic literature search in Cochrane, PubMed (Medline) and EMBASE databases. Inclusion criteria were anterolateral augmentation procedures, including lateral extra-articular tenodesis (LET) and anterolateral ligament reconstruction (ALLR), in combination with ACLR in skeletally immatures. Results: Twenty studies were included after screening 1.485 abstracts. Seventeen studies describe LET techniques, four studies ALLR techniques and one study both techniques. Biomechanical data is scarce and shows conflicting results. Two studies compared ACLR with LET to ACLR in skeletally immatures with promising results in favour of the combined procedure. There were no differences in outcomes between LET and ALLR. Conclusions: Several LET and ALLR techniques have been described for skeletally immature patients and the first clinical data on LET and ALLR is available, which showed promising results. Further research is necessary to evaluate the risk of growth disturbances and overconstraint in skeletally immatures. Level of Evidence: Level IV.