Assessment of Healing and Function After Reconstruction Surgery for Bone Sarcomas
1 other identifier
observational
300
1 country
5
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2018
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 14, 2018
CompletedFirst Submitted
Initial submission to the registry
February 15, 2018
CompletedFirst Posted
Study publicly available on registry
February 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 14, 2027
April 17, 2026
April 1, 2026
9 years
February 15, 2018
April 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Early recovery level
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
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
Study Arms (2)
Regenerative Osseous Surgery
Participants undergoing osseous reconstructive surgery (RegOS) for bone neoplasm. Study visits for post-op assessments will be annually after month-36.
Other Reconstructive Surgery
Participants undergoing other reconstructive surgery for bone neoplasm. Study visits for post-op assessments will be annually after month-36.
Interventions
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.
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%.
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.
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.
Eligibility Criteria
All participants who undergo osseous reconstructive surgery at Memorial Sloan Kettering Cancer Center
You may qualify if:
- 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
You may not qualify if:
- Patients that weight \<17 kilograms
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Memorial Sloan Kettering at Basking Ridge (Consent and Follow Up)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Consent and Followup)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Westchester (Consent and Followup)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10021, United States
Memorial Sloan Kettering at Nassau (Consent and Followup)
Uniondale, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Prince, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2018
First Posted
February 22, 2018
Study Start
February 14, 2018
Primary Completion (Estimated)
February 14, 2027
Study Completion (Estimated)
February 14, 2027
Last Updated
April 17, 2026
Record last verified: 2026-04