TSA Techniques in Glenohumeral OA

Официальное название

Comparison of Shoulder Arthroplasty Techniques in the Treatment of Glenohumeral Osteoarthritis: Protocol

Обзор

Osteoarthritis (OA) of the shoulder is a disease resulting from the wearing down of cartilage over time. OA can produce pain and dysfunction at the affected joint and is a growing occurrence in an aging population. Total shoulder arthroplasty (TSA) is a surgical treatment used to treat patients with shoulder OA which involves replacing the worn-out ball and socket shoulder joint with prosthetic components. TSA is performed today with high success rates, however, complication rates associated with TSA remain prevalent particularly when the arthritis is associated with bone erosion on the glenoid (socket). Given the high rate of revisions associated with TSA treatment in the setting of glenoid bone erosion, a number of surgical strategies have been developed. These surgical techniques include eccentric reaming which involves removing bone from the front of the socket, augmented glenoid component implantation, and posterior bone grafting to compensate for glenoid bone loss, and reverse shoulder arthroplasty. Few research studies have compared these different surgical techniques to one another. Previous studies have been limited to case series with small sample sizes and respective designs. This study is being conducted to determine which approach produces better outcomes. For the purpose of this study we will be comparing total shoulder arthroplasty techniques a) augmented glenoid component and eccentric reaming and b) augmented glenoid component and bone grafting in participants with advanced glenohumeral osteoarthritis.

Подробное описание

Patients who have 10-15 degrees of retroversion will be randomly assigned to one of two standard of care treatment groups: TSA with eccentric glenoid reaming or TSA with augmented glenoid component implantation.

Patients whose condition involves \> 15 degrees of retroversion will be randomly assigned to one of two standard of care treatment groups: TSA with augmented glenoid component implantation or posterior glenoid bone grafting.

The primary objective will be measured by the Western Ontario Osteoarthritis of the Shoulder Index (WOOS) score pre-operatively and at post-operative time intervals (i.e. 3, 6, 12 and 24 months).

Secondary Objectives: i) To determine the survivorship of the components as measured by the degree of radiographic lucencies and component alignment determined by a CT scan at 1 and 5 years post-surgery between study arms in both age groups.

ii) To determine the difference in disease specific quality of life between treatment allocations in both age groups as measured by the Constant score, the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment form (ASES) and the EuroQol Group EQ-5D-5L score pre-operatively and at post-operative time intervals (i.e. 3, 6, 12 and 24 months), as well as adverse events, and health care utilization.

Вмешательства

• Процедура Eccentric Reaming
  Pre-operative CT imaging and surgical planning software based on pre-operative CT scans will be used in each case to determine the degree of eccentric ("high side") anterior reaming to within \< 10 degrees of neutral glenoid version.
• Процедура Augmented Glenoid Component Implantation
  Patients will undergo standard glenoid preparation and implantation of a posteriorly augmented glenoid component. The degree of posterior augment will be based on pre-operative CT scan assessment and templating software with the goal of correcting glenoid retroversion to within 10 degrees of neutral version.
• Процедура Posterior Glenoid Bone Grafting
  Patient will undergo a total shoulder arthroplasty as per standard technique. Glenoid version will be restored to within 10 degrees of neutral with a posterior glenoid bone graft. The bone graft will be harvested from the humeral head and fixed to the posterior glenoid with mini-fragment screws.

Первичные конечные точки

• Western Ontario Osteoarthritis of the Shoulder Index (WOOS) [Срок оценки: 24-Months]
• Western Ontario Osteoarthritis of the Shoulder Index (WOOS) [Срок оценки: 5-Years Post-Operative]

Вторичные конечные точки (8)

• American Shoulder and Elbow Surgeons Standardized Shoulder Assessment form (ASES) [Срок оценки: 24-Months Post-Operative]
• American Shoulder and Elbow Surgeons Standardized Shoulder Assessment form (ASES) [Срок оценки: 5-Years Post-Operative]
• EuroQol EQ-5D-5L [Срок оценки: 24-Months Post-Operative]
• EuroQol EQ-5D-5L [Срок оценки: 5-Years Post-Operative]
• Constant Score [Срок оценки: 24-Months Post-Operative]
• Constant Score [Срок оценки: 5-Years Post-Operative]
• Shoulder Health Utilization [Срок оценки: 5-Years Post-Operative]
• Adverse Events (AE) and Serious Adverse Events (SAE) [Срок оценки: 5-Years Post-Operative]

Критерии участия

Patient Population The target population is both men and women of any age with advanced osteoarthritis of the glenohumeral joint who are considered by the treating surgeon to be a candidate for shoulder replacement. The type of arthritic process will not be considered a deciding factor. The arthritis must be amenable to treatment using either a humeral head replacement (stemmed or stem-less), or a standard total shoulder replacement.

Критерии включения

• Patients who have failed standard non-surgical management of their shoulder osteoarthritis who would benefit from a shoulder arthroplasty. Failed medical management will be defined as persistent pain and disability despite adequate standard non-operative management for 6 months. Medical management will be defined as:

• The use of drugs including analgesics and non-steroidal anti-inflammatory drugs
• Physiotherapy consisting of stretching, strengthening and local modalities (ultrasound, cryotherapy, etc.)
• Activity modification
• Patients will present with a glenoid retroversion between 10-26 degrees.
• Imaging, and intra-operative findings confirming advanced humeral head cartilage loss, with or without glenoid cartilage loss.
• Age 18 years or older

Критерии исключения

• < 10 degrees / > 27 degrees of glenoid retroversion
• Active joint or systemic infection
• Rotator cuff arthropathy
• Significant muscle paralysis
• Charcot's arthropathy
• Major medical illness (life expectancy less than 1 year or unacceptably high operative risk)
• Unable to understand the consent form/process
• Pregnancy
• Psychiatric illness that precludes informed consent
• Unwilling to be followed for the duration of the study
• Retroversion cannot be surgically corrected to within 10 degrees of neutral
• History of previous shoulder surgery on affected side
• Rheumatoid arthritis in the affected shoulder

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• The Ottawa Hospital — Ottawa

Идентификаторы

NCT: NCT02966886 · 20160779-01H

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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