Complications of Bone Morphogenetic Protein-2 Use in Open Transforaminal Lumbar Interbody Fusion
November 27, 2021- 00:06Hello, my name is Allison Miller and my
- 00:09thesis is entitled complications of bone
- 00:12morphogenetic protein to use in open
- 00:15transforaminal lumbar inter body fusion.
- 00:18Degenerative disk disease of the lumbar
- 00:21region causes debilitating symptoms
- 00:23for millions of adults in the US.
- 00:25Today. Increasingly,
- 00:26many individuals with severe disease
- 00:28are electing to undergo surgery.
- 00:31One common technique is the transforaminal
- 00:34approach or transforaminal lumbar inter
- 00:37body fusion lumbar fusion surgeries
- 00:39must be performed within osteo genic
- 00:41material for the fusion to grow,
- 00:43and the gold standard material
- 00:45is bone graft harvested from the
- 00:47patient's iliac Crest.
- 00:49However, there are alternatives
- 00:51to using iliac Crest bone graft.
- 00:54Principally recombinant human bone
- 00:56morphogenetic protein 2 using RH BMP two
- 01:00is thought to be advantageous because
- 01:02it will avoid the morbidity associated
- 01:04with harvesting the patients bone
- 01:07and some studies utilizing different
- 01:09fusion techniques suggests that using
- 01:11RH BMP two may increase fusion rates.
- 01:14For these reasons,
- 01:15RH BMP two is already used in
- 01:18about half of T lift cases.
- 01:20Even though this is an off label
- 01:22indication amid this widespread use,
- 01:24some observation,
- 01:25ULL studies have reported increases
- 01:28in postoperative complications,
- 01:29including increased ridiculopathy,
- 01:32heterotopic ossification,
- 01:34and endplay osteolysis.
- 01:35However,
- 01:35no experimental study to date has
- 01:38quantified the relative risk of
- 01:40these complications in patients,
- 01:42and clinicians must weigh the
- 01:44risks and benefits of RH BMP.
- 01:46Two use with incomplete information.
- 01:49In response,
- 01:50we propose a randomized single
- 01:52blinded 2 arm controlled trial.
- 01:54Our study will seek to characterize
- 01:56the relative risk of radiculopathy,
- 01:58heterotopic ossification,
- 01:59and endplay osteo lysis occurring
- 02:02postoperatively in patients
- 02:04undergoing key lift with RH,
- 02:06BMP two as compared to those
- 02:08undergoing the same procedure
- 02:10using iliac Crest Bone graft.
- 02:12We hypothesize that there will
- 02:14not be a significant difference in
- 02:16postoperative complication risk and
- 02:18each of the three complications.
- 02:20Will be considered independently.
- 02:22Our study will seek to enroll 356
- 02:25patients across 10 clinical sites in
- 02:27the United States over a span of two years.
- 02:29Participants will be randomly
- 02:31assigned to receive either RH,
- 02:32BMP,
- 02:33two or iliac Crest Bone graft
- 02:34during their T lift procedure and
- 02:36each participant will be blinded
- 02:38to their assignment.
- 02:40Through six months of follow-up,
- 02:42we will assess,
- 02:43for each primary outcome,
- 02:44using clinical description the
- 02:46visual analog scale and routine
- 02:49high resolution CT at two weeks
- 02:51and six months after surgery.
- 02:54Our studies experimental design drives
- 02:56many of its advantages over prior studies.
- 02:59Our study will limit selection,
- 03:01respondent and recall biases as well
- 03:03as known and unknown confounding
- 03:05variables to a degree not previously seen
- 03:07in the existing literature on the subject.
- 03:10Our use of high resolution CT
- 03:13will characterize heterotopic
- 03:14ossification and play osteo lysis
- 03:17more reliably than radiograph,
- 03:18and finally are equally sized.
- 03:20Control group will allow for
- 03:22direct comparison of outcomes.
- 03:24However,
- 03:24our study does have limitations.
- 03:26We will be unable to generalize our
- 03:29findings to minimally invasive techniques
- 03:30which may be more popular than open
- 03:33procedures in the coming decades.
- 03:35Our length of follow-up is also limited.
- 03:38It may not be long enough to
- 03:40describe the course of outcomes
- 03:42that may spontaneously resolve.
- 03:43Finally, our study is intensive
- 03:46and rule will require extensive
- 03:48personnel and resources.
- 03:50Since RH BMP two is already used so
- 03:52widely anti lift our study will be
- 03:55of great relevance regardless of
- 03:56the direction of our conclusions.
- 03:58If our findings support increased
- 04:00complication rates when RH
- 04:02BMP two is used in teal,
- 04:04if patients will benefit as they may
- 04:06avoid these complications by choosing
- 04:09alternatives like gold standard,
- 04:10iliac Crest bone graft.
- 04:12However, if her finding support
- 04:14no differences in outcomes,
- 04:16patients will still benefit as they may
- 04:19be reliably encouraged to enjoy them.
- 04:21Potential advantages of RH BMP to use,
- 04:24namely avoiding iliac Crest,
- 04:25bone graft morbidity and
- 04:27heightened fusion rates.
- 04:29Our findings in this case also may
- 04:32support FDA approval for RH BMP,
- 04:34two anti lift which may reduce
- 04:37financial and logistical barriers
- 04:39for patients who may benefit.
- 04:41Thank you for listening.