Assessment of Healing and Function After Reconstruction Surgery for Bone Sarcomas
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| ClinicalTrials.gov Identifier: NCT03442465 |
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Recruitment Status :
Recruiting
First Posted : February 22, 2018
Last Update Posted : March 2, 2022
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Sponsor:
Memorial Sloan Kettering Cancer Center
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
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Brief Summary:
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
| Condition or disease | Intervention/treatment |
|---|---|
| Bone Sarcoma Osteosarcoma Chondrosarcoma Ewing's Sarcoma Osseous Sarcoma Bone Neoplasm | Behavioral: Toronto Extremity Salvage Score Behavioral: Musculoskeletal Tumor Society Score Behavioral: Timed Get Up and Go Test Diagnostic Test: Orthogonal Radiographs Diagnostic Test: Weight Bearing for lower extremities only Diagnostic Test: Range of Motion Diagnostic Test: Osteocalcin Diagnostic Test: Amino terminal propepetide of type 1 collagen Diagnostic Test: N-telopeptide of type 1 collagen |
| Study Type : | Observational |
| Estimated Enrollment : | 150 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Assessment of Healing and Function After Surgical Reconstruction for Osseous Sarcomas |
| Actual Study Start Date : | February 14, 2018 |
| Estimated Primary Completion Date : | February 14, 2024 |
| Estimated Study Completion Date : | February 14, 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Ewing sarcoma
| Group/Cohort | Intervention/treatment |
|---|---|
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Regenerative Osseous Surgery
Participants undergoing osseous reconstructive surgery (RegOS) for bone sarcoma
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Behavioral: 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 total items answered, and dividing this by the maximum possible score based on the number of items answered. This results in a range from 0 -100% with higher values indicating greater ability to complete tasks 31. This scoring allows for the fact that some items may not be answered if they do not apply to an individual. It is anticipated that it will take 20 minutes to complete. Scores for the lower extremity and upper extremity may be combined, but we intend to treat them separately for analysis.
Other Name: TESS Behavioral: 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, hand positioning, manual dexterity, and lifting ability. Individual item scores range from 0-5 with higher values indicating greater function, less pain, or more positive emotional acceptance. A total questionnaire score which is defined as the sum of the individual items divided by the maximum possible score (5 times the number of items) may also be computed. It is represented as a percentage from 0 - 100%.
Other Name: MSTS 3 Behavioral: 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. Diagnostic Test: 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 cortex is counted with a range from 0 to 4 cortices intact.
Other Name: Radiographic Assessments Diagnostic Test: 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. Diagnostic Test: 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, internal rotation and external rotation. Knee range of motion includes flexion and extension. Ankle range of motion includes dorsiflexion and plantarflexion. Diagnostic Test: Osteocalcin This lab assesses bone metabolism and require 5 mL of blood Diagnostic Test: Amino terminal propepetide of type 1 collagen This lab assesses bone metabolism and require 5 mL of blood
Other Name: PINP Diagnostic Test: N-telopeptide of type 1 collagen This lab assesses bone metabolism and require 5 mL of blood |
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Other Reconstructive Surgery
Participants undergoing other reconstructive surgery for bone sarcoma
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Behavioral: 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 total items answered, and dividing this by the maximum possible score based on the number of items answered. This results in a range from 0 -100% with higher values indicating greater ability to complete tasks 31. This scoring allows for the fact that some items may not be answered if they do not apply to an individual. It is anticipated that it will take 20 minutes to complete. Scores for the lower extremity and upper extremity may be combined, but we intend to treat them separately for analysis.
Other Name: TESS Behavioral: 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, hand positioning, manual dexterity, and lifting ability. Individual item scores range from 0-5 with higher values indicating greater function, less pain, or more positive emotional acceptance. A total questionnaire score which is defined as the sum of the individual items divided by the maximum possible score (5 times the number of items) may also be computed. It is represented as a percentage from 0 - 100%.
Other Name: MSTS 3 Behavioral: 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. Diagnostic Test: 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 cortex is counted with a range from 0 to 4 cortices intact.
Other Name: Radiographic Assessments Diagnostic Test: 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. Diagnostic Test: 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, internal rotation and external rotation. Knee range of motion includes flexion and extension. Ankle range of motion includes dorsiflexion and plantarflexion. |
Primary Outcome Measures :
- Early recovery level [ Time Frame: 1 year from surgery ]The primary objective is to assess early recovery level of function of all participants undergoing reconstructive surgery after resection of osseous sarcomas. The early time frame is considered at one year from the sarcoma resection surgery.
- Mid-recovery level [ Time Frame: 3 years from surgery ]The primary objective is to assess mid-recovery level of function of all participants undergoing reconstructive surgery after resection of osseous sarcomas. The mid-recovery time frame is considered at one year from the sarcoma resection surgery.
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| Ages Eligible for Study: | 6 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
All participants who undergo osseous reconstructive surgery at Memorial Sloan Kettering Cancer Center
Criteria
Inclusion Criteria:
- All patients undergoing reconstructive surgery for new bone sarcomas on the orthopaedic surgery service at MSK
- Current or prior history of primary sarcomas 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
Exclusion Criteria:
- Patients with ECOG status score of 4 or 5
- Patients that weight <17 kilograms
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03442465
Contacts
| Contact: Daniel Prince, MD, MPH | 212-639-6488 | princed@mskcc.org | |
| Contact: John Healey, MD | 212-639-7610 | healeyj@mskcc.org |
Locations
| United States, New Jersey | |
| Memorial Sloan Kettering Monmouth (Consent and Followup) | Recruiting |
| Middletown, New Jersey, United States, 07748 | |
| Contact: Daniel Prince, MD, MPH 212-639-6488 | |
| United States, New York | |
| Memorial Sloan Kettering Westchester (Consent and Followup) | Recruiting |
| Harrison, New York, United States, 10604 | |
| Contact: Daniel Prince, MD, MPH 212-639-6488 | |
| Memorial Sloan Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10021 | |
| Contact: Daniel Prince, MD, MPH 212-639-6488 | |
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
| Principal Investigator: | Daniel Prince, MD | Memorial Sloan Kettering Cancer Center |
Additional Information:
| Responsible Party: | Memorial Sloan Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT03442465 |
| Other Study ID Numbers: |
18-014 |
| First Posted: | February 22, 2018 Key Record Dates |
| Last Update Posted: | March 2, 2022 |
| Last Verified: | March 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Memorial Sloan Kettering Cancer Center:
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18-014 Memorial Sloan Kettering Cancer Center |
Additional relevant MeSH terms:
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Sarcoma Osteosarcoma Sarcoma, Ewing Chondrosarcoma Bone Neoplasms Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type |
Neoplasms Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms by Site Bone Diseases Musculoskeletal Diseases |