- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03442465
Assessment of Healing and Function After Reconstruction Surgery for Bone Sarcomas
Assessment of Healing and Function After Surgical Reconstruction for Neoplasms Involving Bone
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
Study Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Daniel Prince, MD, MPH
- Phone Number: 212-639-6488
- Email: princed@mskcc.org
Study Contact Backup
- Name: John Healey, MD
- Phone Number: 212-639-7610
- Email: healeyj@mskcc.org
Study Locations
-
-
New Jersey
-
Middletown, New Jersey, United States, 07748
- Recruiting
- Memorial Sloan Kettering Monmouth (Consent and Followup)
-
Contact:
- Daniel Prince, MD, MPH
- Phone Number: 212-639-6488
-
-
New York
-
Harrison, New York, United States, 10604
- Recruiting
- Memorial Sloan Kettering Westchester (Consent and Followup)
-
Contact:
- Daniel Prince, MD, MPH
- Phone Number: 212-639-6488
-
New York, New York, United States, 10021
- Recruiting
- Memorial Sloan Kettering Cancer Center
-
Contact:
- Daniel Prince, MD, MPH
- Phone Number: 212-639-6488
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients with ECOG status score of 4 or 5
- Patients that weight <17 kilograms
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Regenerative Osseous Surgery
Participants undergoing osseous reconstructive surgery (RegOS) for bone neoplasm.
Study visits for post-op assessments will be annually after month-36.
|
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 Names:
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 Names:
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.
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 Names:
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.
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.
|
Other Reconstructive Surgery
Participants undergoing other reconstructive surgery for bone neoplasm.
Study visits for post-op assessments will be annually after month-36.
|
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 Names:
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 Names:
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.
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 Names:
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 neoplasms.
The early time frame is considered at one year from the neoplasm resection surgery.
|
1 year from 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 neoplasms.
The mid-recovery time frame is considered at one year from the neoplasm resection surgery.
|
3 years from surgery
|
Collaborators and Investigators
Investigators
- Principal Investigator: Daniel Prince, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Osteosarcoma
-
Klinikum StuttgartKlinikum Kassel GmbH (COSS-Biobank)Not yet recruitingOsteosarcoma | High Grade Sarcoma | Recurrent Osteosarcoma | Bone Sarcoma | Undifferentiated Pleomorphic Sarcoma | Bone Tumor | Extraskeletal Osteosarcoma | Osseous Sarcoma | Parosteal Osteosarcoma | Osteoblastic Osteosarcoma | Chondroblastic Osteosarcoma | Fibroblastic Osteosarcoma | Conventional Osteosarcoma | Conventional... and other conditions
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedRecurrent Osteosarcoma | Refractory Osteosarcoma | Stage IV Osteosarcoma AJCC v7 | Stage IVA Osteosarcoma AJCC v7 | Stage IVB Osteosarcoma AJCC v7 | Metastatic OsteosarcomaUnited States, Canada, Puerto Rico
-
M.D. Anderson Cancer CenterRecruitingRecurrent Osteosarcoma | Refractory Osteosarcoma | Metastatic Osteosarcoma | Unresectable Osteosarcoma | Locally Advanced OsteosarcomaUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)Not yet recruitingMetastatic Osteosarcoma | Localized Osteosarcoma | Unresectable Osteosarcoma | Resectable Osteosarcoma
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedRecurrent Osteosarcoma | Metastatic Osteosarcoma | Localized Osteosarcoma | Osteoblastic OsteosarcomaUnited States
-
National Cancer Institute (NCI)SuspendedMetastatic Osteosarcoma | Localized Osteosarcoma | High Grade Osteosarcoma | Secondary OsteosarcomaUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedRecurrent Osteosarcoma | Metastatic Osteosarcoma | Localized OsteosarcomaUnited States
-
National Cancer Institute (NCI)Active, not recruitingRecurrent Ewing Sarcoma | Recurrent Osteosarcoma | Stage III Osteosarcoma AJCC v7 | Stage IV Osteosarcoma AJCC v7 | Stage IVA Osteosarcoma AJCC v7 | Stage IVB Osteosarcoma AJCC v7 | Metastatic Osteosarcoma | Metastatic Ewing Sarcoma | Unresectable Ewing Sarcoma | Unresectable OsteosarcomaFrance
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedRecurrent Osteosarcoma | Metastatic Osteosarcoma | Localized OsteosarcomaUnited States
-
Sarcoma Alliance for Research through CollaborationActive, not recruitingOsteosarcoma | Osteosarcoma Recurrent | Osteosarcoma Metastatic | Osteosarcoma in ChildrenUnited States
Clinical Trials on Toronto Extremity Salvage Score
-
Abant Izzet Baysal UniversityCompleted
-
Oslo University HospitalSophies Minde ASCompletedFemoral Lengthening Might Impair Physical Function and Lead to Structural Changes in Adjacent JointsQuality of Life | Osteoarthritis, Knee | Leg Length Inequality | Osteoarthritis of Hip | Leg; LengtheningNorway
-
University Hospital, ToulouseNot yet recruiting
-
National Cancer Institute (NCI)Not yet recruitingNeuroblastoma | Ganglioneuroblastoma