Patient Outcomes Following Kinematic and Functional Alignment in Robotic-Assisted Total Knee Arthroplasty With Randomized Insert Types

Официальное название

A Prospective Randomized Controlled Trial Comparing Patient Outcomes Following Kinematic and Functional Alignment in Robotic-Assisted Total Knee Arthroplasty Using the VELYS System

Обзор

This study aims to evaluate patient outcomes following robotic-assisted total knee arthroplasty using the VELYS system. Patients undergoing surgery will receive either kinematic alignment or functional alignment as determined by the operating surgeon as part of routine clinical care. Within each surgical technique group, patients will be randomly assigned to receive different implant insert types (medial stabilised or cruciate retaining) using a REDCap-based randomisation process. Patient-reported outcome measures will be collected before surgery and at follow-up time points after surgery to assess clinical outcomes.

Подробное описание

This is a prospective interventional study evaluating outcomes in patients undergoing robotic-assisted total knee arthroplasty using the VELYS system. The study includes patients treated using either kinematic alignment or functional alignment techniques, which are determined by the operating surgeon based on clinical practice and are not randomized as part of the study protocol.

Within each alignment group, participants are randomized to receive one of two implant insert types: medial stabilised (MS) or cruciate retaining (CR). Randomisation is performed using a REDCap-based allocation system.

The primary objective of the study is to assess patient-reported outcomes following surgery. Secondary outcomes may include clinical and functional measures collected at predefined time points, including pre-operative and post-operative follow-up visits.

This study reflects real-world clinical practice while incorporating a randomized component for implant selection. The design allows for evaluation of both implant-related outcomes and comparisons across different alignment techniques, while maintaining clarity regarding which aspects of the intervention are randomized.

Вмешательства

• Устройство Medial Stabilized Insert
  A medial stabilised polyethylene insert used in robotic-assisted total knee arthroplasty to provide enhanced stability during knee motion.
• Устройство Cruciate Retaining Insert
  A cruciate retaining polyethylene insert used in robotic-assisted total knee arthroplasty that preserves the posterior cruciate ligament.

Первичные конечные точки

• Forgotten Joint Score (FJS) [Срок оценки: Pre-operative, 6 weeks, 6 months, and 2 years post-operatively]

Критерии участия

\*Inclusion Criteria:\*

• Patients undergoing robotic-assisted total knee arthroplasty using the VELYS system
• Diagnosis of knee osteoarthritis requiring surgical intervention
• Able to provide informed consent
• Willing to complete patient-reported outcome measures

\*\*Exclusion Criteria:\*\*

• Patients undergoing revision knee arthroplasty
• Presence of active infection
• Inability to comply with follow-up assessments
• Severe co-morbidities that may affect surgical outcomes or participation in the study

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

Открытое

Основная цель

Лечение

Центры проведения

Сингапур · 1 центр

• Singapore General Hospital — Singapore

Идентификаторы

NCT: NCT07533188 · SGH-VELYS-IMPLANT-RCT-2024 · 2024-4071

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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