Liberação menor do peitoral versus não liberação em RSA
Um ensaio de controle randomizado para avaliar a liberação versus não liberação do peitoral menor com artroplastia reversa do ombro
The goal of this clinical trial is to assess if concomitant open pectoralis minor release would improve pain and outcomes after Reverse Shoulder Arthroplasty (RSA). The main questions it aims to answer are:
- whether releasing the pectoralis minor prophylactically could have better pain relief
- whether releasing the pectoralis minor prophylactically could have increased Range of motion (ROM) outcomes
- whether releasing the pectoralis minor prophylactically could have higher final Patient Reported Outcome Measurements (PROMs) Participants will be randomized to either undergo RSA with pectoralis minor release or RSA without pectoralis minor release.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Shoulder arthroplasty has been increasing at exponential rates, particularly due to the rise of reverse shoulder arthroplasty (RSA). Postoperative complications after RSA include infection, instability, hardware component loosening, acromial and scapular spine fractures, neurologic injury, and scapular notching which can all cause pain. However, despite excluding these causes, some patients can have persistent anterior shoulder pain with poor motion.
RSA prostheses work by translating the center of rotation (COR) inferiorly and medially, which increases tension on the deltoid, which is thought to increase the deltoid's mechanical moment arm and thus its ability to abduct and flex the humerus. However, excessive lengthening may be a cause of acromial and scapular spine fractures or neurologic injury. In addition, other structures are tensioned, including the conjoint tendon (short head of the biceps brachii and coracobrachialis) and pec minor (PM). It is unclear if lengthening these muscle-tendon units has functional consequences or whether it can create an intrinsic pathology. It is therefore feasible that muscle lengthening could create tendinitis, which could lead to persistent anterior shoulder pain after RSA. In addition, excessive tension or over-activity in the PM is also known to be a cause of altered scapula biomechanics.
Good scapula biomechanics after RSA are critical to preserving an impingement-free range of motion, which is important in maximizing postoperative outcomes, implant longevity, and preventing component loosening and instability. However, it is known from the non-arthroplasty population that during repetitive movements with scapular protraction, a hyperactive or spasming PM shortens and develops contracture, leading to protracted resting scapular position and altered scapular contribution to shoulder range of motion.1 This causes altered scapular kinematics, or dyskinesia, and alters scapular accommodation to shoulder motion, a well-known feature in various shoulder pathologies. This can be a major problem after RSA when scapula accommodation is critical to ROM and function.
Due to the expendability of the pectoralis minor, its release would cause minimal functional detriment in non-pathological cases, but in cases of overactivity, release could markedly improve scapula biomechanics. This can be performed open or arthroscopically, but the concomitant open release would be straight-forward at the time of the index surgery through the same incision
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- Emory Clinic
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Atlanta, Georgia, Estados Unidos, 30329
- Emory Healthcare Orthopaedics and Spine Center
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- All patients undergoing surgery for reverse total shoulder arthroplasty
- Patients willing and able to provide informed consent
Exclusion Criteria:
- Revision arthroplasty
- Reverse shoulder arthroplasty for proximal humerus fractures
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: RSA com liberação do peitoral menor
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The pectoralis minor is a muscle on the anterior chest wall attaching to the coracoid process. In the group undergoing pectoralis minor release, through the same deltopectoral incision that will not be extended or different as compared to the RSA only group, the pec minor will be exposed on the medial aspect of the coracoid at the upper part of the incision. It will be cut from its insertion on the coracoid while being careful to protect any neurovascular structures. RSA is the current Standard of Care (SOC) |
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Comparador Ativo: RSA sem liberação do peitoral menor
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RSA is the current Standard of Care (SOC) |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Visual analog Scale (VAS) pain scores
Prazo: Baseline, 6 months
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The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Study participants will be asked to rate their current level of pain by placing a mark on the line |
Baseline, 6 months
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Visual analog Scale (VAS) pain scores
Prazo: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year (each follow-up visit)
|
The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Study participants will be asked to rate their current level of pain by placing a mark on the line |
Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year (each follow-up visit)
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American Shoulder and Elbow Score (ASES)
Prazo: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year (each follow-up visit)
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The ASES is a 100-point scale that consists of two dimensions: pain and activities of daily living. There is one pain scale worth 50 points and ten activities of daily living worth 50 points. |
Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year (each follow-up visit)
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Subjective Shoulder Value (SSV)
Prazo: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year (each follow-up visit)
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Subjective Shoulder Value is study participant's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100% |
Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year (each follow-up visit)
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Change in Range of motion (ROM)
Prazo: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year (each follow-up visit)
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ROM is calculated in terms of angles. Lower number suggests restricted motion. |
Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year (each follow-up visit)
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Change in Scapulohumeral Rhythm (SHR) on Digital Dynamic Radiography (DDR)
Prazo: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year (each follow-up visit)
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SHR is the ratio of humeral abduction over the change in scapula upward rotation during humeral abduction. This SHR will be captured on Digital Dynamic Radiography (DDR) and reported as a change in SHR before and after the interventions. |
Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year (each follow-up visit)
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Number of complications
Prazo: 1 year
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Number of complications post intervention would be measured. |
1 year
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Number of reoperations
Prazo: 1 year
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Number of reoperations following intervention would be measured. |
1 year
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Eric Wagner, MD, Emory University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- STUDY00007201
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