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Diagnostic Tests and Questionnaires in Studying Healing and Function in Patients after Surgical Reconstruction for Tumors Involving Bone
Trial Status: active
This study uses diagnostic tests and questionnaires to study how well patients heal and function after surgical reconstruction for tumors involving bone. After the bone tumor is removed, the gap in the bone has to be fixed in a process called reconstruction. Sometimes, the missing bone can be replaced with bone from an organ donor or from another part of the body. Regenerative surgery helps the body to create new bone to fill the gap. No matter which type of reconstruction is done, there is a loss of usual function after the surgery. Studying quality of life in patients receiving reconstructive surgery for bone cancer may help identify the short-and-intermediate term effects of treatment on patients with bone sarcomas.
Inclusion Criteria
All patients undergoing reconstructive surgery involving the bone on the Orthopaedic Surgery Service at MSKCC. This will include primary surgery, revision surgery, and amputations
Current or prior history of primary neoplasms involving osseous structures, including all subtypes
Age >= 4
Patients must read and understand English
Exclusion Criteria
Patients that weigh < 17 kilograms
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03442465.
I. To assess early and mid-level recovery of function of all patients undergoing reconstructive surgery after resection of neoplasms involving bone.
SECONDARY OBJECTIVE:
I. Subgroup analysis of patients undergoing regenerative surgery. Short and intermediate-term functional recovery among these patients will be assessed. In addition, the metabolic profile during distraction osteogenesis and healing in patients undergoing regenerative surgery will be evaluated.
EXPLORATORY OBJECTIVE:
I. To examine the influence of chemotherapy and radiation therapy upon bone metabolism and healing in patients undergoing regenerative surgery. Additionally, exploratory long-term assessments will be analyzed.
OUTLINE: This is an observational study. Patients are assigned to 1 of 2 groups.
GROUP I: Patients undergoing regenerative osseous reconstructive surgery (RegOS) complete the Timed Get Up and Go Test (TGUG), the Musculoskeletal Tumor Society Score (MSTS), and the Toronto Extremity Salvage Score (TESS) questionnaire, as well as radiographic measurements 3, 6, 9, 12, 16, 20, and 24 months, then every 12 months after surgery until study closure. Patients also undergo collection of blood monthly during the distraction and consolidation phase of RegOS for levels of vitamin D, calcium, protein and substances related to bone growth and breakdown, and for inflammation.
GROUP II: Patients undergoing other reconstructive surgeries complete TGUG, MSTS, TESS, and radiographic measurements as in Group I.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationMemorial Sloan Kettering Cancer Center
