Randomized double blind clinical trial of ABM/P-15 versus allograft in noninstrumented lumbar fusion surgery.

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.