Assessment of Healing and Function After Reconstruction Surgery for Bone Sarcomas

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 4 years and older
• All sexes
• No healthy volunteers
• Child, Adult, Older adult

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

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

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

Conditions

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

Being tested

Toronto Extremity Salvage Score, Musculoskeletal Tumor Society Score, Timed Get Up and Go Test, Orthogonal Radiographs, Weight Bearing for lower extremities only

Keywords

18-014, Memorial Sloan Kettering Cancer Center

Medical subject headings

Bone Neoplasms, Osteosarcoma, Chondrosarcoma, Sarcoma, Ewing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Toronto Extremity Salvage ScoreBehavioural

  Also called TESS

  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.

• Musculoskeletal Tumor Society ScoreBehavioural

  Also called MSTS 3

  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%.

• Timed Get Up and Go TestBehavioural

  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.

• Orthogonal RadiographsDiagnostic test

  Also called Radiographic Assessments

  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.

• Weight Bearing for lower extremities onlyDiagnostic test

  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.

• Range of MotionDiagnostic test

  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 being measured

The primary outcome is the main question the study is designed to answer.

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.

   Measured: 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.

   Measured: 3 years from surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted22 Feb 2018
2. Study start14 Feb 2018
3. Primary completion14 Feb 2027 (estimated)
4. Study completion14 Feb 2027 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Bone SarcomaStudies of the same condition, open and under way.
• More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.