OTA 2006 Posters

Scientific Poster #102 Geriatrics

· Review of Healing with rhBMP-2/ACS Use in the Medicare-aged Population
J. Dean Cole, MD (a-Medtronic, USA, Inc); Steve Nguyen, MD (n);
Donna L. Lamb, MBA, BSN (a-Medtronic, USA, Inc);
Fracture Care Center at Florida Hospital,
Orlando, Florida, USA

Background: rhBMP-2/ACS (INFUSE® Bone Graft) has been shown to be beneficial in the treatment of open tibia fractures with intramedullary nailing; however, there are no conclusive studies showing efficacy in Medicare populations (age 60). The purpose of retrospective study was to better understand healing in the age 60 group (60-84 years) as compared to those age <60 (18-59 years) in a variety of orthopaedic surgical procedures and conditions.

Methods: IRB approval was obtained for retrospective review of 98 patients who received rhBMP-2/ACS between May 2004 and July 2005. 35 patients were age 60 and 63 patients age <60. There were 19 males age 60 and 37 age <60. There were 16 females age 60 and 26 age <60:

 

 age 60 group

 age <60 group

   Nonunion

 Primary

  Nonunion  Primary
 Femur

 10

  

 12

 1

 Tibia/fibula

 7

  14

 1

 Humerus

 6

 1

 4

  
 Ulna/radius

 2

 1

 6

 1

 Clavicle

 0

  

 5

  
 Calcaneus

 1

  

 3

 1

 Foot/ankle arthrodesis

 4

 2

 11

 2

 Patella

 0

  

 1

  
 Talus

 0

 1

 1

  


Results: Nonunion/failure occurred in 4 patients age <60 (1 amputation for vascular issue), with varying risk factors. There was no nonunion/failure in the age 60 group. Delayed healing occurred in 2 patients with 1 in each group. Postoperative infection was noted in 4 patients with 2 in each group. One infection in the age 60 group may have been a dormant infection prior to surgery and the other was healed by 6 months. One infection in the age <60 group was the result of a full-thickness necrotic wound of the foot with tibia healing noted by 12 months. The second infection in the age <60 group was a wound infection with bone healing noted at 6 months. No operative complications or allergic reactions were noted in either group.

Conclusion: Both groups had similar orthopaedic conditions with similar rates of healing and infection. No safety issues or allergies were noted in either group. In a consecutive series of patients with challenging orthopaedic conditions, there appears to be a beneficial effect on bone healing when using rhBMP-2/ACS (INFUSE® Bone Graft) in the age 60 group. However, additional prospective study should be undertaken to further define healing in this population.

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.