The purpose of the study was to determine the effectiveness of rhBMP-2 when applied to an absorbable collagen sponge for interbody fusion with allograft spacers.

Seventy-seven consecutive patients requiring inter-body fusion with one hundred and eighteen levels were included in the study. In thirty-six patients cervical or lumbar interbody fusions were performed using allograft and rhBMP-2. In the remaing allograft was used with demineralised bone matrix. In patients undergoing anterior cervical decompression and fusion (ALIF) machined allograft spacers were supplemented with anterior locking plates. In those scheduled for anterior lumbar inter-body fusion (ALIF) or transforaminal lumbar interbody fusion (TLIF), machined allograft spacers were supplemented with posterior pedicle screw constructs. There were no stand alone ALIF procedures. All patients undergoing surgery were assessed preoperatively and at two weeks, six weeks, three, six, twelve, twenty-four months following surgery.Their Oswestry disability index (ODI) questionaires, Visual analogue scale (VAS) scores and a pain diagram were recorded. Radiographic measurements were made on the electronic public access computer system (EPACS).

All patients with allograft plus rhBMP-2 showed radiographic evidence of fusion by six months following surgery. The allograft with demineralised bone matrix group took considerably longer to achieve the same radiographic end plate appearance. Subsidence was obvious on radiographs in greater than 50% of cases with allograft and rhBMP-2 at three months. It was noted to occur between six weeks and three months and there was no significant subsidence after six months. This was statistically significant with a p< 0.0001 (fisher exact test). The average subsidence for the entire rhBMP-2 group at twelve months was 16.5%(SE 2.5% and range 0–58%) and for the allograft and bone matrix group was 4.6%(SE.74% range 0–15%)with a p< 0.0001 (independant t test).

Although high rates of fusion can be accomplished with allograft and rhBMP-2 (100%), significant subsidence occurs in greater than 50% of lumbar spine cases and 30% of cervical spine cases. This is possibly a result of early bone turnover with loss of structural support of the allograft spacer and end plate resorption.

We carried out a prospective study to determine whether the addition of a recombinant human bone morphogenetic protein (rhBMP-2) to a machined allograft spacer would improve the rate of intervertebral body fusion in the spine. We studied 77 patients who were to undergo an interbody fusion with allograft and instrumentation. The first 36 patients received allograft with adjuvant rhBMP-2 (allograft/rhBMP-2 group), and the next 41, allograft and demineralised bone matrix (allograft/demineralised bone matrix group). Each patient was assessed clinically and radiologically both pre-operatively and at each follow-up visit using standard methods. Follow-up continued for two years.

Every patient in the allograft/rhBMP-2 group had fused by six months. However, early graft lucency and significant (> 10%) subsidence were seen radiologically in 27 of 55 levels in this group. The mean graft height subsidence was 27% (13% to 42%) for anterior lumbar interbody fusion, 24% (13% to 40%) for transforaminal lumbar interbody fusion, and 53% (40% to 58%) for anterior cervical discectomy and fusion. Those who had undergone fusion using allograft and demineralised bone matrix lost only a mean of 4.6% (0% to 15%) of their graft height.

Although a high rate of fusion (100%) was achieved with rhBMP-2, significant subsidence occurred in more than half of the levels (23 of 37) in the lumbar spine and 33% (6 of 18) in the cervical spine. A 98% fusion rate (62 of 63 levels) was achieved without rhBMP-2 and without the associated graft subsidence. Consequently, we no longer use rhBMP-2 with allograft in our practice if the allograft has to provide significant structural support.