Идёт набор NCT05073263

Full Vs Partial Weightbearing During the First Six Weeks of Rehab. After Fibular Collateral Ligament Reconstruction

Без фазы С лечением Knee Injuries

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Physical Therapy.
Кому может быть актуально: Состояния в реестре: Knee Injuries. Базовые параметры: 14 лет — 59 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Full Weightbearing Versus Partial Controlled Weightbearing During the First Six Weeks of Rehabilitation After Reconstruction of the Fibular Collateral Ligament: a Randomized Controlled Trial

Обзор

This is a prospective randomized controlled trial with the purpose to determine if patients undergoing fibular collateral ligament (FCL) reconstruction alone or combined FCL and anterior cruciate ligament (ACL) reconstructions can safely begin full controlled weightbearing for the first six weeks after surgery.

Подробное описание

Patients will be randomly assigned to one of two rehabilitation protocols for the first six weeks post-surgery:

1. partial weightbearing 2. full controlled weightbearing

An immobilizer brace in extension will be used from post-operative day 0 through 13 and a CTi ligament knee brace (Össur Americas, Foothill Ranch, California) will be used from 14 to 42 days post-surgery to protect against side-to-side motion while weight bearing.

Specific Aims

1. Primary Aim: To determine if there is a difference in millimeters of varus gapping on anteroposterior (AP) stress radiographs at six months post-surgery between patients who are partial weight bearing versus full controlled weight bearing during the first six weeks of post-surgical rehabilitation. This distance will be compared to varus gapping measured on the contralateral uninjured control knee. 2. Secondary Aim: To determine if there is a difference in pain, edema, and range of motion, gait, quadriceps strength, and patient reported outcomes between groups.

The Investigators hypothesize that there will be no clinically significant difference (\< 2 mm change) in varus gapping between the control and treatment groups. Results of this study will help to expedite return to pre-injury levels of activity and decrease adverse sequelae associated with non-weight bearing such as osteopenia, muscle atrophy, loss of ankle range of motion, and increased risk of deep vein thrombosis.

The current standard of care for FCL reconstruction is early controlled partial weight -bearing for the first six weeks after surgery.

Вмешательства

Другое Physical Therapy
Patient is randomized to the weightbearing group the day after surgery.

Первичные конечные точки

Gapping (mm) measured on Standard of Care Varus stress radiographs [Срок оценки: Pre-operative]
Gapping (mm) measured Standard of Care Varus stress radiographs [Срок оценки: 6 months post-surgery]

Вторичные конечные точки (5)

Numeric Pain Scale (NPS) (0-10 rating) [Срок оценки: Baseline and 6 months]
Measurements by physical therapists (Edema, thigh circumference) [Срок оценки: 4,7, and 10 months after surgery]
Measurements by physical therapists (Range of Motion) [Срок оценки: 4,7, and 10 months after surgery]
Measurements by physical therapists (Quadriceps strength, gait analysis) [Срок оценки: 4,7, and 10 months after surgery]
Patient reported outcome scores [Срок оценки: Baseline, 3 months, 6 months, 1 year]

Критерии участия

Критерии включения

≥ 14 years old, <60
Reconstruction of FCL alone
Combined FCL + ACL reconstructions
Males or females
Is willing and able to comply with the clinical trial plan and able to understand and sign the Patient Informed Consent Form.