Unravelling the Etiology of Shoulder Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- T1Rho MRI
研究概览
简要总结
Osteoarthritis (OA) is a progressive disease resulting from the degradation of synovial joint articular cartilage over time.
The hallmark symptom is diffuse aching and progressive pain made worse with activity. Loss of range of motion and compromised function inevitably follow. This degenerative disease can affect the shoulder joint. When symptoms become refractory to conservative treatment such as anti-inflammatory medication, steroid injections, activity modification or physical therapy; surgery (total or reverse shoulder arthroplasty) may be considered.
Idiopathic shoulder OA is typically characterized by posterior subluxation of the humeral head upon the glenoid and posterior bone loss. An imbalance in the application of forces applied to the proximal humerus by the posterior and anterior rotator cuff muscles has been postulated to be the leading cause of idiopathic shoulder OA. However, there is only preliminary evidence to support this theory and the etiology of this pattern of deformity is unknown. The theory the posterior humeral head subluxation is a precursor to OA is only supported by very low-level evidence and no longitudinal studies have been conducted. As a result, the cause and natural history of shoulder OA remains unknown.
Research into this area is urgently needed to generate knowledge that will inform future treatments aimed at modifying and slowing the progression of shoulder OA and to reduce the need for shoulder replacement therapy.
The aim of this project is to develop an understanding of the pathophysiology of shoulder OA.
详细描述
Purpose: The aim of this project is to develop an understanding of the pathophysiology of shoulder OA. This project will recruit two groups of 30 participants, (60 participants in total) and follow them over a period of 5-years.
Group 1- Participants with posterior subluxation of the humeral head and show early signs of degeneration in their shoulder 'disease group' Group 2- Participants with posterior subluxation of the humeral head and show no signs of degeneration 'control/healthy' group
Hypotheses: The investigators hypothesize that there are several factors that contribute to the development of shoulder OA. Uncovering those pathways will lead to more targeted therapy. (1) The posterior rotator cuff muscles (infraspinatus/teres minor) apply relatively greater force than the anterior (subscapularis) cuff; an imbalance in the force couple occurs and the humeral head translates posteriorly on the glenoid; progressive posterior subluxation of the humeral head occurs and degeneration of the glenoid and humeral head cartilage follow. (2) Posterior subluxation of the humeral head is associated with progressive cartilage proteoglycan loss. (3) Pre-morbid glenoid morphology including increased retroversion is associated with the development of shoulder OA.
Participant Involvement: The following will be completed with participants: T1Rho Magnetic Resonance Imaging (MRI), quantitative Computed Tomography (qCT), functional and motion analysis at baseline, year 2 and year 4 in the 'affected' shoulder in both groups 1 and 2. These tests will also be conducted on the asymptomatic, contralateral shoulder in Group 1 participants at baseline and year 4. The finite element model validation will be performed in years 2 and 3, and participant-specific finite element analysis (which has no active participant involvement) will occur in years 3 to 5. Overall study analysis will occur in year 5. This project will be done in two-parts. The first part will consist of six participants; assuming further funding is obtained, part two of the study will proceed. The second part of the project will be based on successfully obtaining funds to continue the remainder of the study recruitment (54 participants) and testing. As pilot data is urgently needed to secure granting funds to support this overall project, the investigators will commence with recruiting the first 6 participants. Once further funds are secured, the remaining portion (recruitment of 54 participants) of the project will continue.
Objectives: (1) Determine whether patients with posterior humeral head subluxation have an imbalance between the posterior and anterior rotator cuff muscles. Objective 1 will be assessed through T1Rho MRI, and functional testing/motion analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults <60 years of age
- •Posterior humeral head subluxation >55% (determined from imaging)
排除标准
- •>60 years of age
- •History of shoulder instability
- •History of shoulder trauma including fracture
- •Neurological disorders of the upper limb
- •Imaging evidence of humeral head or glenoid bony deformity
- •Rotator cuff pathology
- •Labral pathology
- •Pre-existing joint deformity (OA) cases greater than grade I (as per Samilson and Prieto)
结局指标
主要结局
T1Rho MRI
时间窗: 5-Years Post-Allocation
MRI will be used to measure the muscle-fat ratio, and tendon thickness. Increased fat-infiltration, and tendon thinning indicates a worse outcome.
Finite Element Analysis
时间窗: 5-Years Post-Allocation
This will be combined with motion analysis results to gain a better understanding of the internal loading within the tissues of the joint that could explain degenerative changes observed by imaging. Increased stresses, and muscle imbalance result in a worse outcome.
Motion Analysis
时间窗: 5-Years Post-Allocation
A kinematic evaluation of the shoulder while performing functional tasks will help us determine how the rotator cuff muscle imbalance influences the shoulder joint kinematics.
qCT (Low Dose CT)
时间窗: 5-Years Post-Allocation
Used to measure bone loss and density. Increased bone loss, and decreased density indicate a worse outcome.
次要结局
未报告次要终点