TY - JOUR

T1 - Randomized double blind clinical trial of ABM/P-15 versus allograft in non-instrumented lumbar fusion surgery

AU - Kjær Jacobsen, Michael

AU - Andresen, Andreas Duch Killerich

AU - Bennedsgaard Jespersen, Annette

AU - Støttrup, Christian

AU - Carreon, Leah Y

AU - Overgaard, Soren

AU - Andersen, Mikkel Østerheden

PY - 2020/5

Y1 - 2020/5

N2 - BACKGROUND CONTEXT: Due to poor bone stock in the elderly, a noninstrumented fusion is commonly performed in Scandinavia when instability is present. Allograft bone is often used as graft extender with consequent low fusion rates. The use of 15 amino acid residue (ABM/P-15) has shown superior fusion rates in dental and cervical spinal surgery but no clinical studies have been conducted in noninstrumented lumbar fusion surgery.PURPOSE: To evaluate patient reported outcomes (PROs) and the intertransverse fusion rate in noninstrumented posterolateral fusion with either ABM/P-15 or allograft.STUDY DESIGN: Double-blind randomized clinical trial.PATIENT SAMPLE: Patients 60 years or older with degenerative spondylolisthesis undergoing decompression and noninstrumented posterolateral fusion.OUTCOME MEASURES: Visual analog scales for back and leg pain, Oswestry Disability Index and EuroQoL-5D.METHODS: One hundred one patients were enrolled in the study and randomized 1:1 to either ABM/P-15 (mixed 50/50, 5cc/level) or allograft bone (30 g/level), both mixed with local bone graft. PROs were collected at baseline and at 12 and 24 months after surgery. The patients underwent 1-year postoperative fine cut computed tomography-scans (0.9 mm) with reconstructions, independently evaluated by three reviewers. Fusion status was concluded by consensus of two of the three as "fusion" or "no fusion."RESULTS: There were 49 patients available for analysis in both cohorts. The two groups were similar in terms of sex distribution, age, and number of levels fused. The fusion rate was significantly higher in the ABM/P-15 group with 50% fused compared with 20% in the allograft group. PROs at baseline and at all follow-up time points were similar between the two groups.CONCLUSIONS: Patients undergoing noninstrumented posterolateral fusion augmented with ABM/P-15 had a statistically significantly higher fusion rate compared with allograft when evaluated with postoperative fine cut computed tomography-scans (0.9 mm) with reconstructions. However, this did not translate to better clinical outcomes.

AB - BACKGROUND CONTEXT: Due to poor bone stock in the elderly, a noninstrumented fusion is commonly performed in Scandinavia when instability is present. Allograft bone is often used as graft extender with consequent low fusion rates. The use of 15 amino acid residue (ABM/P-15) has shown superior fusion rates in dental and cervical spinal surgery but no clinical studies have been conducted in noninstrumented lumbar fusion surgery.PURPOSE: To evaluate patient reported outcomes (PROs) and the intertransverse fusion rate in noninstrumented posterolateral fusion with either ABM/P-15 or allograft.STUDY DESIGN: Double-blind randomized clinical trial.PATIENT SAMPLE: Patients 60 years or older with degenerative spondylolisthesis undergoing decompression and noninstrumented posterolateral fusion.OUTCOME MEASURES: Visual analog scales for back and leg pain, Oswestry Disability Index and EuroQoL-5D.METHODS: One hundred one patients were enrolled in the study and randomized 1:1 to either ABM/P-15 (mixed 50/50, 5cc/level) or allograft bone (30 g/level), both mixed with local bone graft. PROs were collected at baseline and at 12 and 24 months after surgery. The patients underwent 1-year postoperative fine cut computed tomography-scans (0.9 mm) with reconstructions, independently evaluated by three reviewers. Fusion status was concluded by consensus of two of the three as "fusion" or "no fusion."RESULTS: There were 49 patients available for analysis in both cohorts. The two groups were similar in terms of sex distribution, age, and number of levels fused. The fusion rate was significantly higher in the ABM/P-15 group with 50% fused compared with 20% in the allograft group. PROs at baseline and at all follow-up time points were similar between the two groups.CONCLUSIONS: Patients undergoing noninstrumented posterolateral fusion augmented with ABM/P-15 had a statistically significantly higher fusion rate compared with allograft when evaluated with postoperative fine cut computed tomography-scans (0.9 mm) with reconstructions. However, this did not translate to better clinical outcomes.

U2 - 10.1016/j.spinee.2020.01.009

DO - 10.1016/j.spinee.2020.01.009

M3 - Journal article

C2 - 32001384

VL - 20

SP - 677

EP - 684

JO - Spine Journal

JF - Spine Journal

SN - 1529-9430

IS - 5

ER -