Osteosarcoma Clinical Trial
Official title:
Assessment of Healing and Function After Surgical Reconstruction for Neoplasms Involving Bone
NCT number | NCT03442465 |
Other study ID # | 18-014 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | February 14, 2018 |
Est. completion date | February 14, 2025 |
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
Status | Recruiting |
Enrollment | 180 |
Est. completion date | February 14, 2025 |
Est. primary completion date | February 14, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan Kettering Westchester (Consent and Followup) | Harrison | New York |
United States | Memorial Sloan Kettering Monmouth (Consent and Followup) | Middletown | New Jersey |
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 |
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