Assessment of Healing and Function After Reconstruction Surgery for Bone Sarcomas

Recruiting

• Conditions: Osteosarcoma; Chondrosarcoma; Bone Sarcoma; Ewing's Sarcoma; Bone Neoplasm; Osseous Sarcoma
• Interventions: 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

• Registration Number: NCT03442465
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-14
• Study First Submitted: 2018-02-15
• Study First Submitted QC: 2018-02-20
• Study First Posted: 2018-02-22
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15
• Primary Completion: 2025-02-14
• Study Completion: 2025-02-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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

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Exclusion Criteria

• Patients that weight <17 kilograms

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Regenerative Osseous Surgery	Weight Bearing for lower extremities only	Participants undergoing osseous reconstructive surgery (RegOS) for bone neoplasm. Study visits for post-op assessments will be annually after month-36.
Regenerative Osseous Surgery	Musculoskeletal Tumor Society Score	Participants undergoing osseous reconstructive surgery (RegOS) for bone neoplasm. Study visits for post-op assessments will be annually after month-36.
Regenerative Osseous Surgery	Toronto Extremity Salvage Score	Participants undergoing osseous reconstructive surgery (RegOS) for bone neoplasm. Study visits for post-op assessments will be annually after month-36.
Regenerative Osseous Surgery	Timed Get Up and Go Test	Participants undergoing osseous reconstructive surgery (RegOS) for bone neoplasm. Study visits for post-op assessments will be annually after month-36.
Regenerative Osseous Surgery	Range of Motion	Participants undergoing osseous reconstructive surgery (RegOS) for bone neoplasm. Study visits for post-op assessments will be annually after month-36.
Other Reconstructive Surgery	Range of Motion	Participants undergoing other reconstructive surgery for bone neoplasm. Study visits for post-op assessments will be annually after month-36.
Regenerative Osseous Surgery	Orthogonal Radiographs	Participants undergoing osseous reconstructive surgery (RegOS) for bone neoplasm. Study visits for post-op assessments will be annually after month-36.
Other Reconstructive Surgery	Musculoskeletal Tumor Society Score	Participants undergoing other reconstructive surgery for bone neoplasm. Study visits for post-op assessments will be annually after month-36.
Other Reconstructive Surgery	Orthogonal Radiographs	Participants undergoing other reconstructive surgery for bone neoplasm. Study visits for post-op assessments will be annually after month-36.
Other Reconstructive Surgery	Toronto Extremity Salvage Score	Participants undergoing other reconstructive surgery for bone neoplasm. Study visits for post-op assessments will be annually after month-36.
Other Reconstructive Surgery	Timed Get Up and Go Test	Participants undergoing other reconstructive surgery for bone neoplasm. Study visits for post-op assessments will be annually after month-36.
Other Reconstructive Surgery	Weight Bearing for lower extremities only	Participants undergoing other reconstructive surgery for bone neoplasm. Study visits for post-op assessments will be annually after month-36.

Primary Outcome Measures

Name	Time	Method
Early recovery level	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.
Mid-recovery level	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.

Trial Locations

Locations (3)

Memorial Sloan Kettering Monmouth (Consent and Followup); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Westchester (Consent and Followup); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States