Assessment of Healing and Function After Reconstruction Surgery for Bone Sarcomas

Официальное название

Assessment of Healing and Function After Surgical Reconstruction for Neoplasms Involving Bone

Обзор

The purpose of this study is to look at the amount of function that returns in participants that have reconstruction with bone graft or artificial device and in participants who have tumor surgery plus regenerative osseous surgery. The study will look at the level of function for a period of 3 years after the surgery. Another purpose of this study is to look at how well the bone heals in participants undergoing regenerative surgery

Вмешательства

• Поведенческое Toronto Extremity Salvage Score
  Participant-reported outcome score. For lower extremities, this is a 33 item questionnaire containing 32 5 point Likert scale items and 1 open ended response item. For upper extremities, this is a 31 item questionnaire containing 31 5 point Likert scale items and 1 open ended response item. Individual item responses range from 1-5 with higher values indicating a task is easier to complete. A total questionnaire score can also be calculated by taking the sum of the scores minus the number of tota
• Поведенческое Musculoskeletal Tumor Society Score
  Clinician-reported global score. For lower extremities, this is a 6 item questionnaire containing 6 point Likert scale items which cover pain, function, emotional acceptance, walking ability, gait, and necessary support. Individual item scores range from 0-5 with higher values indicating greater function, less pain, or more positive emotional acceptance. For upper extremities, this is a 6 item questionnaire containing 6 point Likert scale items which cover pain, function, emotional acceptance, h
• Поведенческое Timed Get Up and Go Test
  Validated functional measurement, for lower extremities only. The patient is observed and timed while s/he rises from an arm chair, walks 3 meters, turns, walks back, and sits down again. The test predicts the patient's ability to go outside alone safely and quantifies functional mobility. The test requires no special equipment and will take less than one minute to complete.
• Диагностический тест Orthogonal Radiographs
  The distance of bone transport is measured, accounting for calibration of the radiographs. The presence of bone regenerate between the transported segment is determined by the presence of continuous calcified callus from the proximal segment to the distal segment. Each of the orthogonal radiographs is used to visualize two cortices: the AP radiographs visualizes the medial and lateral cortices and the lateral radiograph measures the anterior and posterior cortices. Each continuous calcified cort
• Диагностический тест Weight Bearing for lower extremities only
  As part of the current standard of care, patients are asked to stand on a scale with the affected lower extremity on the scale and the unaffected extremity on a block which is level with the scale. The patient is asked to place as much weight as possible on the affected extremity and this weight Is recorded. Each patient's total weight is then measured and the percent of weight bearing is calculated as the amount of weight bearing over the total body weight.
• Диагностический тест Range of Motion
  As part of the current standard of care, the joints of the affected extremity are assessed for passive range of motion at each follow up visit by the clinician. If surgery is on the femur, the hip and knee joints are assessed for range of motion. Whereas for the tibia, the knee and ankle joints are assessed. These assessments would be measured using a goniometer placed alongside the extremity and recorded for each direction of movement. Hip range of motion includes flexion, extension, abduction,

Первичные конечные точки

• Early recovery level [Срок оценки: 1 year from surgery]
• Mid-recovery level [Срок оценки: 3 years from surgery]

Критерии участия

Критерии включения

• All patients undergoing reconstructive surgery for neoplasms involving bone on the orthopaedic surgery service at MSK
• Current or prior history of primary neoplasms involving osseous structures, including all subtypes
• Confirmation of diagnosis that has been performed by the MSK's Department of Pathology via direct review of tissue/slides
• Patients must read and understand English
• Age >/=4
• Patients must read and understand English

Критерии исключения

• Patients that weight <17 kilograms

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 5 центров

• Memorial Sloan Kettering at Basking Ridge (Consent and Follow Up) — Basking Ridge
• Memorial Sloan Kettering Monmouth (Consent and Followup) — Middletown
• Memorial Sloan Kettering Westchester (Consent and Followup) — Harrison
• Memorial Sloan Kettering Cancer Center — New York
• Memorial Sloan Kettering at Nassau (Consent and Followup) — Uniondale

Идентификаторы

NCT: NCT03442465 · 18-014

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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