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Patient Education Series

Current Research Results:
Surgical Decision Making Study
Prospective Analysis of Fusion Rate with BMP and Allograft Bone

 

 

Does Collaboration Change Surgical Decisions In Spine Surgery?
Abstract
James Reynolds, M.D., Paul Slosar, M.D., Noel Goldthwaite, M.D., Edward Sun, M.D.

Background Context: There has been collaboration for the purpose of improving surgical decisions in spine surgery for many years in many different formats such as case presentations and case reviews. The effect of collaboration on the surgical decision making process, however, has never been evaluated. Recently, on-line peer to peer collaboration has become popular. In our practice it is routine that the attending surgeon present all planned surgeries in a multi-disciplinary face to face format. The effects of such collaboration on the final surgery decision have not been previously investigated.

Purpose: To determine the effects of collaboration on potential changes in surgical decisions.

Study Design: Consecutive review of scheduled surgical cases.

Outcome measures: Any changes to the original surgical plan as a result of collaboration. Changes were divided into major or minor. A major change was classified as a change in approach, surgical level, modification (i.e. addition or subtraction of instrumentation, fusion, fusion techniques such as addition or subtraction of biologic or autogenously graft, or decompression), or cancellation of the procedure. A minor change was classified as different instrumentation, additional testing before surgery, addition or subtraction of monitoring and intraoperative imaging, or a positioning change.

Methods: All elective surgical cases were reviewed in a regularly scheduled case conference. Each attending surgeon completed a surgery scheduling form that included: patient name, diagnosis, planned procedure, positioning, instrumentation, additional equipment, and additional monitoring. Other details recorded: surgical levels, approach, need for decompression and need for fusion. Surgical procedures were subdivided into simple and complex. Simple procedures included one or two level decompressions, one level fusions, kyphoplasty, and hardware removal. All other procedures were considered complex. The surgeon presented the case including history, physical examination, imaging studies, and the planned procedure. All cases were then discussed. If there was disagreement, then discussion occurred about the recommended procedure. For each case consensus was reached. If the procedure was changed, the change was classified as major or minor.

Results: A total of 56 cases were reviewed. There were 35 complex and 21 simple procedures. Changes from the original plan occurred in 7 (12.5%) of all cases presented. There were 5 major changes and 2 minor changes. All 7 changes occurred in the complex procedures (20%).

Conclusions: Collaboration in the form of case presentations at a weekly surgical conference resulted in changes in the surgical plan of 20% of complex surgeries. The routine review of planned complex spine surgical procedure by peer collaboration appears to improve surgical decisions.

 

Accelerating Lumbar Fusions by combining rhBMP-2 with allograft bone: A Prospective Analysis of Interbody Fusion Rates and Clinical Outcomes
Abstract
Paul J. Slosar, MD; Robert Josey, MD; James Reynolds, MD

Background Context: Recombinant human bone morphogenetic protein-2 (rhBMP-2) is an osteoinductive protein approved for use in the anterior lumbar interspace. High fusion rates with rhBMP-2 have been reported with threaded interbody allograft dowels. There may be a clinical benefit for the patient by adding rh-BMP 2 to the allograft.

Purpose: To compare the fusion rates and clinical outcomes of patients treated with allograft interbody fusions with and without the addition of rh-BMP 2.

Study Design: Prospective consecutive patient enrollment with minimum 24 month follow-up.

Patient Sample: 75 patients with lumbar interbody fusions at 1-3 spinal segments.
Outcomes Measures: Clinical: Numerical Rating Scale (NRS) and Oswestry Disability Index (ODI).

Radiographic: X-ray and CT scan analysis using the Molinari-Bridwell fusion scale.

Methods: 75 patients scheduled for lumbar fusion were enrolled sequentially. Group 1: 30 patients had anterior interbody allografts alone. Group 2: 45 patients had anterior interbody allograft filled with rhBMP-2. All cases had posterior pedicle screw instrumentation. A total of 165 surgical levels (62 allograft alone /103 allograft + BMP) were included. Fusion data and clinical outcomes were collected for a minimum of 2 years after surgery.

Results: Statistically higher fusion rates were observed in the patients with BMP at all time points compared to allograft alone. Group 2 (+ BMP) fusion rates were 94%, 100%, and 100% at 6, 12 and 24 months after surgery. Group 1 (-BMP) fusion rates were 66%, 84%, and 89% at the same time intervals. Clinical outcomes were significantly improved in Group 2 compared to Group 1 at 6 months. There were no revisions (0%) in the BMP group and 4 revision fusion surgeries (13%) in the allograft group. No untoward effects were attributable to the rhBMP-2.

Conclusions: Our study confirms the efficacy of an innovative lumbar fusion technique: an interbody femoral ring allograft, combined with an osteoinductive stimulant (rhBMP-2), protected by pedicle screws. This combination of a structural interbody allograft with rhBMP-2 eliminates the insult of iliac crest harvest, allows for reliable radiographic analysis and results in successful fusion formation in 100% of the cases in this study.


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