Go Kubota1, Hiroto Kamoda2, Sumihisa Orita3, Kazuyo Yamauchi3, Yoshihiro Sakuma4, Yasuhiro Oikawa5, Kazuhide Inage3, Takeshi Sainoh6, Jun Sato7, Michihiro Ito8, Masaomi Yamashita9, Junichi Nakamura3, Takane Suzuki10, Kazuhisa Takahashi3, Seiji Ohtori11. 1. Department of Orthopedic Surgery, Eastern Chiba Medical Center, Chiba, Japan. 2. Department of Orthopaedic Surgery, Chiba Cancer Center, Chiba, Japan. 3. Department of Orthopedic Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan. 4. Department of Orthopaedic Surgery, National Hospital Organization Chiba Medical Center, Chiba, Japan. 5. Department of Orthopaedic Surgery, Chiba Children's Hospital, Chiba, Japan. 6. Department of Orthopaedic Surgery, Sainou Hospital, Toyama, Japan. 7. Department of Orthopaedic Surgery, Chiba Aoba Municipal Hospital, Chiba, Japan. 8. Department of Clinical Laboratory, Chiba University Medical Hospital, Chiba, Japan. 9. Department of Orthopaedic Surgery, Social Insurance Funabashi Central Hospital, Chiba, Japan. 10. Department of Environmental Medicine, Graduate School of Medicine, Chiba University, Chiba, Japan. 11. Department of Orthopedic Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan. Electronic address: sohtori@faculty.chiba-u.jp.
Abstract
BACKGROUND CONTEXT: Platelet-rich plasma (PRP) accelerates bone union in vivo in a rodent model of spinal fusion surgery. However, PRP's effect on bone union after spinal surgery remains unclear. PURPOSE: The objective of this study was to evaluate the efficacy of PRP after posterolateral lumbar fusion (PLF) surgery. STUDY DESIGN/ SETTING: Single-center prospective randomized controlled clinical trial with 2-year follow-up. PATIENT SAMPLE: The patient sample included a total 62 patients (31 patients in the PRP group or 31 patients in the control group). OUTCOME MEASURES: The outcome measures included the bone fusion rate, the area of bone fusion mass, the duration of bone fusion, and the clinical score using the visual analog scale (VAS). MATERIALS AND METHODS: We randomized 62 patients who underwent one- or two-level instrumented PLF for lumbar degenerative spondylosis with instability to either the PRP (31 patients) or the control (31 patients) groups. Platelet-rich plasma-treated patients underwent surgery using an autograft bone chip (local bone), and PRP was prepared from patient blood samples immediately before surgery; patients from the control group underwent PLF without PRP treatment. We assessed platelet counts and growth factor concentrations in PRP prepared immediately before surgery. The duration of bone union, the postoperative bone fusion rate, and the area of fusion mass were assessed using plain radiography every 3 months after surgery and by computed tomography at 12 or 24 months. The duration of bone fusion and the clinical scores for low back pain, leg pain, and leg numbness before and 3, 6, 12, and 24 months after surgery were evaluated using VAS. RESULTS: Data from 50 patients with complete data were included. The bone union rate at the final follow-up was significantly higher in the PRP group (94%) than in the control group (74%) (p=.002). The area of fusion mass was significantly higher in the PRP group (572 mm2) than in the control group (367 mm2) (p=.02). The mean period necessary for union was 7.8 months in the PRP group and 9.8 months in the control group (p=.013). In the PRP, the platelet count was 7.7 times higher and the growth factor concentrations were 50 times higher than those found in plasma (p<.05). There was no significant difference in low back pain, leg pain, and leg numbness in either group at any time evaluated (p>.05). CONCLUSIONS: Patients treated with PRP showed a higher fusion rate, greater fusion mass, and more rapid bone union after spinal fusion surgery than patients not treated with PRP.
RCT Entities:
BACKGROUND CONTEXT: Platelet-rich plasma (PRP) accelerates bone union in vivo in a rodent model of spinal fusion surgery. However, PRP's effect on bone union after spinal surgery remains unclear. PURPOSE: The objective of this study was to evaluate the efficacy of PRP after posterolateral lumbar fusion (PLF) surgery. STUDY DESIGN/ SETTING: Single-center prospective randomized controlled clinical trial with 2-year follow-up. PATIENT SAMPLE: The patient sample included a total 62 patients (31 patients in the PRP group or 31 patients in the control group). OUTCOME MEASURES: The outcome measures included the bone fusion rate, the area of bone fusion mass, the duration of bone fusion, and the clinical score using the visual analog scale (VAS). MATERIALS AND METHODS: We randomized 62 patients who underwent one- or two-level instrumented PLF for lumbar degenerative spondylosis with instability to either the PRP (31 patients) or the control (31 patients) groups. Platelet-rich plasma-treated patients underwent surgery using an autograft bone chip (local bone), and PRP was prepared from patient blood samples immediately before surgery; patients from the control group underwent PLF without PRP treatment. We assessed platelet counts and growth factor concentrations in PRP prepared immediately before surgery. The duration of bone union, the postoperative bone fusion rate, and the area of fusion mass were assessed using plain radiography every 3 months after surgery and by computed tomography at 12 or 24 months. The duration of bone fusion and the clinical scores for low back pain, leg pain, and leg numbness before and 3, 6, 12, and 24 months after surgery were evaluated using VAS. RESULTS: Data from 50 patients with complete data were included. The bone union rate at the final follow-up was significantly higher in the PRP group (94%) than in the control group (74%) (p=.002). The area of fusion mass was significantly higher in the PRP group (572 mm2) than in the control group (367 mm2) (p=.02). The mean period necessary for union was 7.8 months in the PRP group and 9.8 months in the control group (p=.013). In the PRP, the platelet count was 7.7 times higher and the growth factor concentrations were 50 times higher than those found in plasma (p<.05). There was no significant difference in low back pain, leg pain, and leg numbness in either group at any time evaluated (p>.05). CONCLUSIONS:Patients treated with PRP showed a higher fusion rate, greater fusion mass, and more rapid bone union after spinal fusion surgery than patients not treated with PRP.
Authors: Tucker C Callanan; Antonio T Brecevich; Craig D Steiner; Fred Xavier; Justin A Iorio; Celeste Abjornson; Frank P Cammisa Journal: Eur Spine J Date: 2018-12-03 Impact factor: 3.134