Study Comparing SBS and LRTI for Treatment of CMC Arthritis

Официальное название

A Randomized Prospective Multicenter Study Comparing Suture Button Suspensionplasty (SBS) with Ligament Reconstruction and Tendon Interposition (LRTI)

Обзор

A multi-center, randomized control trial comparing the two standard of care surgical treatments for CMC arthritis ; trapezial excision with or without soft tissue interposition and /or ligament reconstruction (LRTI) versus the suture button suspension arthroplasty (SBS). Patient reported outcomes will be collected at 6 and 6 weeks, 3, 6, and 12 months.

Подробное описание

LRTI is a well established treatment of CMC arthritis with good results.However, comparable results have also been reported with SBS, with the latter procedure eliminating the need for flexor carpi radialis (FCR) harvest and interposition, resulting in potential shorter OR time and donor site morbidity. To date, there have been biomechanical studies comparing LRTI vs suture button suspension arthroplasty (SBS), and clinical studies comparing trapeziectomy alone vs SBS, but to the best of our knowledge, no random control studies comparing LRTI with SBS.The primary objective is to determine whether treatment with SBS results in improved overall pain relief compared to LRTI as measured by patient reported outcomes.Secondary outcome measures will be to determine if SBS results in shorter OR time and improved grip and pinch strength compared to LRTI, as well as have comparable return to work times and amount of radiographic shortening as shown on radiographs (metacarpal shortening has been felt to lead to decreased grip strength).

Вмешательства

• Процедура CMC Arthroplasty
  Surgical intervention to treat CMC arthritis

Первичные конечные точки

• Visual Analog Scale- Pain [Срок оценки: 12 Months]
• Disabilities of the Arm, Shoulder and Hand Questionnaire [Срок оценки: 12 Months]
• Patient Related Wrist Evaluation Questionnaire [Срок оценки: 12 Months]

Вторичные конечные точки (4)

• Operative Time [Срок оценки: Intraoperative]
• Strength [Срок оценки: 12 Months]
• Range of Motion [Срок оценки: 12 Months]
• Work Productivity and Activity Impairment: Specific Health Problem Questionnaire [Срок оценки: 12 Months]

Критерии участия

Критерии включения

• Age fifty years or older
• Isolated carpometacarpal (trapeziometacarpal) osteoarthritis
• Failure to respond to non-operative management
• Willing and able to consent on their own behalf and follow the protocol and clinical visits as described
• Able to read and understand English or have interpreter available

Критерии исключения

• Previous surgery for CMC arthritis
• Duration of symptoms for less than 6 months
• Greater than or equal to 30 degrees of ipsilateral metacarpophalangeal (MCP) hyperextension
• Scaphotrapeziotrapezoidal (stage 4 CMC) arthritis
• Other significant ipsilateral wrist or hand pathology
• A history of inflammatory arthropathy
• A requirement for concomitant surgery for another condition
• Any previous hand or wrist fracture
• Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, not mentally competent to give consent, intellectually challenged patients without adequate support, etc.)

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 2 центра

• South Campus Research Unit for Bone and Soft Tissue — Calgary
• Fraser Orthopaedic Research Society — New Westminster

Идентификаторы

NCT: NCT05111405 · FHREB # 2021-112

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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