CClinicalTrials.gg
RecruitingNCT03442465Updated Apr 17, 2026

Assessment of Healing and Function After Reconstruction Surgery for Bone Sarcomas

An observational study in Bone Sarcoma, Osteosarcoma and Chondrosarcoma, sponsored by Memorial Sloan Kettering Cancer Center. Recruiting at 5 sites in United States. Open to participants aged 4 Years and older. Per ClinicalTrials.gov, last updated 2026-04-17.

Sponsored by Memorial Sloan Kettering Cancer Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
4 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Bone Sarcoma
  • Osteosarcoma
  • Chondrosarcoma
  • Ewing's Sarcoma
  • Osseous Sarcoma
  • Bone Neoplasm

Keywords

  • 18-014
  • Memorial Sloan Kettering Cancer Center
03

Who can participate

Ages eligible
4 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All participants who undergo osseous reconstructive surgery at Memorial Sloan Kettering Cancer Center

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

Exclusion Criteria:

  • Patients that weight \<17 kilograms
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • Regenerative Osseous Surgery

    Participants undergoing osseous reconstructive surgery (RegOS) for bone neoplasm. Study visits for post-op assessments will be annually after month-36.

    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

  • Other Reconstructive Surgery

    Participants undergoing other reconstructive surgery for bone neoplasm. Study visits for post-op assessments will be annually after month-36.

    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

Interventions

  • BehavioralToronto 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.

    Also known as: TESS

  • BehavioralMusculoskeletal 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%.

    Also known as: MSTS 3

  • BehavioralTimed 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 testOrthogonal 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.

    Also known as: Radiographic Assessments

  • Diagnostic testWeight 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 testRange 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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year from surgery

  2. 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.

    Time frame: 3 years from surgery

06

Study locations

5 of 5 sites recruiting
  • Memorial Sloan Kettering at Basking Ridge (Consent and Follow Up)
    Basking Ridge, New Jersey 07920, United States
    • Christopher Prince, MD, MPH · Contact · 212-639-6488
    Recruiting
  • Memorial Sloan Kettering Monmouth (Consent and Followup)
    Middletown, New Jersey 07748, United States
    • Daniel Prince, MD, MPH · Contact · 212-639-6488
    Recruiting
  • Memorial Sloan Kettering Westchester (Consent and Followup)
    Harrison, New York 10604, United States
    • Daniel Prince, MD, MPH · Contact · 212-639-6488
    Recruiting
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10021, United States
    • Daniel Prince, MD, MPH · Contact · 212-639-6488
    Recruiting
  • Memorial Sloan Kettering at Nassau (Consent and Followup)
    Uniondale, New York 11553, United States
    • Daniel Prince, MD, MPH · Contact · 212-639-6488
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03442465
Lead sponsor
Memorial Sloan Kettering Cancer Center
Responsible party
Sponsor
First posted
Feb 22, 2018
Start date
Feb 14, 2018
Primary completion
Feb 14, 2027 (estimated)
Completion
Feb 14, 2027 (estimated)
Last update
Apr 17, 2026

Study contacts

Daniel Prince, MD, MPH
Contact
princed@mskcc.org
212-639-6488
Carol Morris, MD
Contact
MorrisC@mskcc.org
212-639-7611
Daniel Prince, MD
principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion