A Prospective Study of Conventional Bone Marrow Biopsies and Bone Marrow Biopsies Performed Through the Portomar(TM), Using a Modified PROMIS Pain Intensity Scale for Pain Assessment

Date de début de l'étude : 22 novembre 2022

Inclusion Criteria: * • Patients with a previous bone marrow disorder diagnosis who will require multiple bone marrow biopsies over the course of their treatment, for example patients with plasma cell dyscrasia or leukemia. * Men and non-pregnant women of age ≥ 21 years with ECOG performance status ≤ 2. * Any hematologic (platelets above 50, ANC \> 1.0, hemoglobin \> 7), renal (patients not on dialysis), or hepatic (patients with bilirubin below 2.5) function status suitable to undergo port implantation and subsequent bone marrow biopsies. * Patients must be able to understand and be willing to sign a voluntary informed consent form and agree to compliance with the protocol schedule; with the knowledge that they may withdraw consent at any time without impact on future medical care. Exclusion Criteria: * • Patients with any other ongoing, concomitant, comorbid illness including but not limited to uncontrolled diabetes, NYHA class III or worse heart failure, uncontrolled coronary artery disease/arrhythmia. * Patients unable to comply with the study schema. * Confirmed pregnancy at time of screening or on implantation day prior to anesthesia/sedation. * Patients unable to come off of anticoagulation medications for their procedure. * Patients with active infection. * Patients with \< 0.5 cm or \> 2.5 cm of soft tissue between screw head and skin at the target site of implantation. This is based on the patient's prior imaging studies (i.e. CT/MR or ultrasound imaging). * Patient has contra-indication to conscious sedation or anesthesia services * Patients who have had prior bone marrow biopsy within 2 weeks of the study biopsy. * Patients with coagulopathy such that INR cannot be corrected \< 2.0. * Patients who are prisoners or wards of the court. * Patients with alcohol or substance abuse disorder defined by DSM V criteria. * Patients with the diagnosis of a major psychiatric disorder such as schizophrenia or major depression defined by the DSM-V criteria. * Patients with osteoporosis defined as L1 vertebrae bone density lower than 90 Hounsfield units