P-450: Comparison of a battery powered device (OnControl) versus manual Jamshidi needle for bone marrow biopsy in adult patients with plasma cell disorders: A prospective randomized control trial (RCT)

Introduction: Bone marrow aspiration and biopsies (BMA&B) provide diagnostic and prognostic information in patients with plasma cell disorders. The use of Jamshidi needle for manual BMA&B has been the established method of choice. Powered biopsy devices (OnControl) are gaining popularity due to shorter procedural time and operator convenience, but are limited by increased incidence of crush artifact and inadequate sampling. We performed a prospective randomized control trial (RCT) to assess the quality of BMA&B and the patient and provider convenience.

Methods: Adult patients with plasma cell disorders undergoing BMA&B were consented by nine operators who are familiar with both techniques. A total of 100 patients underwent randomization to receive BMA&B by OnControl drill vs manual Jamshidi needle. A questionnaire was used to assess the intensity of pain and the impact of BMA&B on general activity, work, and sleep at baseline and on days 1, 3 and 7. Sedation information, time for completion of procedure, and demographic data were collected. The BM core biopsy length (in mm), crush artifact, and adequacy of the BMA&B were assessed by a pathologist blinded for randomization. The provider convenience with both techniques were collected from the operators prior to the availability of results.

Results: There were no significant demographic differences between the 2 groups (OnControl vs Jamshidi, respectively). The median age was 65.5 (37-79) vs 63 (35-81) years. Overall, 50% of patients were male, and 35% were black. 91% had a prior BMA&B within the last 2 years (65.9% had 2-4 prior BMA&B and 83.5% had a prior OnControl drill experience). 31% had chronic pain. 38% had lytic lesions, 6% had osteoporosis, 5% had osteopenia and 31% were on active bisphosphonates. 22% had compression fractures and 11% had a prior h/o kyphoplasty. 26% (11% vs 15%, p=0.247) had inadequate sampling - unsuccessful core biopsy (1% vs 4%, p=0.181), aspiration artifact (3% vs 2%, p=0.530), cortical bone only (3% vs 3%, p=0.631) and hemodiluted specimen (5% vs 6%, p=0.575) but were not statistically different between 2 groups. The core length was significantly longer for the OnControl [14 (5-30) vs 9.5 (3-23) mm, p=0.003]. The time for procedure was significantly shorter for OnControl [7 (3-24) vs 10.5 (4-30) minutes, p=0.06]. There were no differences observed between the 2 groups in terms of pain post procedure, or the impact of pain. Operator assessment unanimously favored the use of OnControl device. On a scale of 1-10 (1 being the least inconvenient and 10 the most convenient), median operator convenience for OnControl vs Jamshidi was 10 (range, 9-10) vs 3 (range, 2-7), p< 0.001.

Conclusions: The OnControl system was associated with less procedural time and a better core biopsy without increased incidence of crush artifact. The robust size of the core biopsy may negate the need for repeat procedures. The operators favored the use of OnControl device over a manually exhausting Jamshidi needle for BMA&B.