OTA 2006 Posters

Scientific Poster #30 Reconstruction

·Clinical Outcomes for Long-Bone Nonunions Implanted with Bone Morphogenetic Protein
Clifford B. Jones, MD; James R. Ringler, MD; Terrence J. Endres, MD
(all authors - a-Medtronic and Stryker)
Michigan State University, Orthopaedic Associates of Grand Rapids,
Grand Rapids, Michigan, USA

Background: The use of bone morphogenetic protein (BMP) has been suggested for treatment of long-bone nonunions. Currently two BMP implants are available, Infuse (rhBMP-2) and OP-1 (BMP-7).

Purpose: Our objective was to assess clinical outcomes for patients implanted with BMP for treatment of long-bone nonunions.

Study Design/Patients: This was a retrospective cohort study of clinical outcomes. Twenty patients (6 females, 14 males) treated with rhBMP-2 along with 32 patients (18 females, 14 males) treated with BMP-7 underwent treatment for closure of nonunions of the femur, tibia, or humerus. The BMPs were used in conjunction with other implant materials: autologous platelets (Magellan), 15% of patients; ceramic granules (MasterGraft), 12% of patients; allograft cortical cancellous bone chips, 50% of patients; or autograft (local bone or other sites), 12% of patients.

Outcome Measures/Methods: The outcome measures were radiographs taken at 3, 6, and 12 months postoperatively. Anteroposterior and lateral radiographs were evaluated for evidence of osseous fusion where BMP implants were used. Images were analyzed for evidence of bridging bone and overall union success. Fusion success was graded as definitely fused or not fused. Films were not available for all patients at all time points. Results are presented as percent of patients evaluated at the time point.

Results: The results presented below are the percentage of evaluated patients exhibiting either bridging bone or fusion success (patients exhibiting/patients evaluated).
 Months

 rhBMP-2

 BMP-7

   Bridging Bone  Fusion Success  Bridging Bone Fusion Success 
 3  95% (19/20) 40% (8/20)   84% (26/31)  52% (16/31)
 6 94% (16/17)   88% (15/17)  88% (22/25)  72% (18/25)
 12  100% (10/10)  100% (10/10)  100% (21/21)  95% (20/21)


Matched for time periods, there is no statistical difference between cohorts for either fusion success or presence of bridging bone (P >0.27 in all instances, two-tailed Fisher exact test).

Conclusions: Compared to historical controls, the use of rhBMP-2 or rhBMP-7 for long-bone nonunions exhibited fusion success rates of 95% or better at 12 months. The fusion success at 3 months was nearly 50% for the study population as a whole. Further studies into rhBMP for osseous healing are required.

 Infuse

 Cohort

 OP-1

 Bridging Bone  Fusion Success  Time Postsurgery  Bridging Bone  Fusion Success
 95% (19/20)  40% (8/20)  3 months  84% (26/31)  52% (16/31)
 94% (16/17)  88% (15/17)  6 months  88% (22/25)  72% (18/25)
 100% (10/10)  100% (10/10)  12 months  100% (21/21)  95% (20/21)

 Infuse

 Demographic category

 OP-1

 14

 Male

 14

 6

 Female

 18

46.5; 16 - 84

 Ave. age at surgery (years; range)

 48.7; 19 - 81
 196 ± 64

 Ave. weight at surgery (lbs ± std)

  179 ± 61
 85% (17/20)

 Previous surgery at implant site

  94% (30/32)
 11% (2/18)

 Workers Comp

  0% (0/27)
 28% (5/18)

 Medicare /Medicaid patient

  33% (9/27)
 61% (11/18)

 Private pay

  67% (18/27)
 11% (2/18)

 Diabetes

  30% (9/30)
 28% (5/18)

 Smoker

  46% (13/38)
 40% (6/15)

 Alcohol

  48% (12/25)
 43% (6/14)

 Use of NSAIDs/steroids

  37% (7/19)
 21% (3/14)

 Infected site at implantation

  10% (3/29)
 30% (6/20)

 Femur

  41% (13/32)
 40% (8/20)

 Tibia

  50% (16/32)
 30% (6/20)

 Humerus

  9% (3/32)
 35% (7/20)

 Proximal

  12% (4/32)
 35% (7/20)

 Midshaft

  41% (13/32)
 30% (6/20)

 Distal

  47% (15/32)
 5% (1/20)

 Magellan used

  22% (7/32)
 5% (1/20)

 Local bone used

  6% (2/32)
 15% (3/20)

 Other autograft used

  0% (0/32)
 30% (6/20)

 MasterGraft used

  0% (0/32)
 40% (8/20)

 Allograft chips used

  56% (18/32)
 10% (2/20)

 Subsequent revision, all causes

  13% (4/32)

· The FDA has not cleared this drug and/or medical device for the use described in this presentation (i.e., the drug or medical device is being discussed for an "off label" use). · · FDA information not available at time of printing.

If noted, the author indicates something of value received. The codes are identified as a-research or institutional support; b-miscellaneous funding; c-royalties; d-stock options; e-consultant or employee; n-no conflicts disclosed, and *disclosure not available at time of printing.
· The FDA has not cleared this drug and/or medical device for the use described in this presentation (i.e., the drug or medical device is being discussed for an "off label" use). · · FDA information not available at time of printing.