Knee Flexionater to Avoid Motion Restoring Surgery

Официальное название

Comparing High Intensity Stretch Device Combined With Physical Therapy Versus Physical Therapy Alone to Prevent Motion-Restoring Surgery Following Primary Total Knee Arthroplasty: Study Protocol for a Randomized Controlled Trial

Обзор

The goal of this clinical trial is to learn whether adding a stretching device to standard physical therapy can help people regain knee bending after total knee replacement surgery. Some people have difficulty bending their knee during recovery. When this happens, doctors may recommend another procedure called motion-restoring surgery to improve knee movement. This study aims to answer two main questions. First, does adding a hydraulic high-intensity stretching device to physical therapy help people regain knee bending after surgery? Second, does using the device affect recovery, daily activities, or the chance of needing another procedure? Researchers will compare two treatment approaches. One group will receive standard physical therapy alone. The other group will receive standard physical therapy and will also use a hydraulic high-intensity stretching device called the Ermi Knee Flexionater at home. Participants who receive the device will use it at home each day in addition to attending their physical therapy sessions. Researchers will measure how well participants can bend their knee and will ask questions about pain, daily function, and activity level. Participants will also complete simple walking and mobility tests. Study visits will occur about four weeks after surgery when participants enroll, and again at about eight weeks, twelve weeks, six months, one year, and two years after surgery. Researchers will compare results between the two groups to see whether the stretching device improves recovery after knee replacement.

Вмешательства

• Устройство Hydraulic high Intensity Stretch Device
  A hydraulic high-intensity mechanical stretch device (Ermi Knee Flexionater) used as an adjunct to standard postoperative physical therapy following primary total knee arthroplasty. The device is designed to apply controlled, patient-actuated stretch to increase knee flexion range of motion. Participants assigned to this intervention will use the device at home daily for approximately one hour, in addition to attending prescribed physical therapy sessions. Device use will begin at approximately
• Другое Standard Physical Therapy
  Supervised postoperative physical therapy following primary total knee arthroplasty. Therapy includes range of motion exercises, strengthening, neuromuscular re-education, manual therapy, and functional rehabilitation as determined by the treating clinician.

Первичные конечные точки

• Change from Enrollment in Active and Passive Knee Flexion Range of Motion (Degrees) [Срок оценки: Baseline (Enrollment at 4 weeks post-operative), 8 weeks post-operative, 12 weeks post-operative, 6 months post-operative, 1 year post-operative, and 2 years post-operative]

Вторичные конечные точки (6)

• Change from Enrollment in KOOS Score [Срок оценки: Baseline (Enrollment), 8 weeks, 12 weeks, 6 months, 1 year, and 2 years post-operative]
• Change from Enrollment in WOMAC Score [Срок оценки: Baseline (Enrollment), 8 weeks, 12 weeks, 6 months, 1 year, and 2 years post-operative]
• Change from Enrollment in Visual Analog Scale (VAS) Pain Score [Срок оценки: Baseline (Enrollment), 8 weeks, 12 weeks, 6 months, 1 year, and 2 years post-operative]
• Change from Enrollment in Timed Up and Go (TUG) Test Time (Seconds) [Срок оценки: Baseline (Enrollment), 8 weeks, 12 weeks, 6 months, 1 year, and 2 years post-operative]
• Change from Enrollment in Six-Minute Walk Test (6MWT) Distance (Meters) [Срок оценки: Baseline (Enrollment), 8 weeks, 12 weeks, 6 months, 1 year, and 2 years post-operative]
• Number of Participants Experiencing Adverse Events [Срок оценки: From enrollment to 2 years post-operative follow-up]

Критерии участия

Критерии включения

• Age 40 years or older
• Undergoing primary total knee replacement surgery
• Knee flexion less than 105 degrees at approximately 4 weeks after surgery
• Considered a candidate for motion-restoring surgery, with any surgery delayed until after 2 months of nonoperative treatment

Критерии исключения

• Not willing to participate
• Diagnosis of advanced rheumatoid arthritis
• Neurological deficit affecting the operative leg
• Revision total knee replacement or previous major surgery on the same knee
• Cognitive impairment
• Prior total hip replacement on the same side (ipsilateral total hip arthroplasty)
• Living more than 2 hours from the study site or unwilling to attend required local physical therapy visits

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

США · 1 центр

• INOV8 Orthopedics — Houston

Идентификаторы

NCT: NCT07454356 · RCT-EF-225

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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