Bone Health

OTA 2002 - Session 3 Session III - Polytrauma Fri., 10/11/02 Polytrauma, Paper #18, 4:15 PM Functional Outcomes after Lower Extremity Amputations for Trauma: Effects of Amputation Level, Soft Tissue Coverage, and Prosthetic Design Ellen J. MacKenzie, PhD ; Michael J. Bosse, MD; Renan C. Castillo, MS; Douglas G. Smith, MD; and The LEAP Study Group; Center for Injury Research and Policy, The Johns Hopkins University, Bloomberg School of Public Health, Baltimore, Maryland, USA (-NIAMS/NIH Grant)

AAOS Annual Meeting 2004 Thursday, March 11, 2004 Tarun Bhargava, MD Wichita KS Naftaly Attias, MD Phoenix AZ Dana G. Seltzer, MD Phoenix AZ R Curtis Bay Phoenix AZ (*) Retrospective chart review suggests that operative delays of up to twenty-four hours do not adversely affect infection rate. Introduction: This study was undertaken to determine whether time to definitive treatment of open fractures influences probability of patient infection. Previous studies have found time interval between injury and wound debridement to be either nonsignificant or a major prognostic factor. These studies, however, have not included patients for whom the time interval exceeded 24 hours. Previous research has suggested that in order to minimize the probability of infection, operative irrigation and debridement should occur “as soon as possible” or up to twenty-four hours following injury. Methods: This study is a retrospective chart review of all open fractures treated at a level one trauma center in an urban hospital from January 1999 through June 2002. Data were collected concerning patient demographics, etiology of the injury, associated injuries, time of injury, time of arrival to hospital, time of initial operative irrigation and debridement, method of fracture fixation, and wound closure. Fracture grade and infections were also recorded. Fractures were separated by grade and time elapsed from injury to operative treatment. The time elapsed was divided into the following periods: 0-6 hours, 6-12 hours, 12-24 hours, and greater than 24 hours. Univariate and simultaneous logistic regressions were used to assess the impact of these variables on probability of infection. Results: A total of 220 patients with 245 fractures were included in the data set. Overall infection was 7.3%. Infection incidence in those treated before twenty-four hours was 5.2%, for those treated after twenty-four hours, incidence was 24.1%. Fracture grade and delay of greater than twenty-four hours prior to operative irrigation and debridement were significant predictors of infection in both univariate and simultaneous logistic regression analysis. Discussion and Conclusions: Our findings support prior research demonstrating a relationship between fracture grade and infection rate. Additionally, our study and the work of others suggest that delays of up to twenty-four hours do not adversely affect infection rate. Furthermore, we found evidence that delays of greater than twenty-four hours from injury to operative irrigation and debridement are associated with increased infection rate amongst open fractures.

OTA 2002 - Session 3 Session III - Polytrauma Fri., 10/11/02 Polytrauma, Paper #17, 4:09 PM Prosthetic Device Satisfaction among Patients with Lower Extremity Amputation Due To Trauma Juliana K. Cyril, MPH, PhD; Ellen J. MacKenzie, PhD; Douglas G. Smith, MD; Michael J. Bosse, MD; The LEAP Study Investigators; Johns Hopkins University, Bloomberg School of Public Health, Baltimore, Maryland, USA

OTA 2002 - Session 2 Session II - Post-Traumatic Reconstruction Fri., 10/11/02 Post Traumatic Reconstruction, Paper #12, 3:25 PM The Impact of a Dedicated Skeletal Infectious Disease Specialist in the Treatment of Chronic and Post-Traumatic Skeletal Infections Bruce H. Ziran, MD ; N. Rao, MD; Joon Y. Lee, MD; Ronald A. Hall, MD; University of Pittsburgh, Department of Orthopaedics, Pittsburgh, Pennsylvania, USA Purpose: The collaboration of an infectious disease specialist with the orthopaedic surgeon should theoretically provide a more comprehensive approach to the treatment of osteomyelitis. At our institution, the surgeon who treated most of the skeletal infections initially began without dedicated support from the infectious disease department. This was followed by the introduction of an infectious disease specialist who was dedicated to the treatment of skeletal infections. We evaluated the impact of such a collaboration to establish whether there was any benefit from the team approach. We hypothesized that successful ablation or suppression of skeletal infections is improved with use of such a dedicated team. Methods: A consecutive cohort of 70 patients with known skeletal infections was treated. The protocol consisted of staging, debridement and resection, and antibiotic therapy, followed by reconstruction in all cases. All patients had tech/ind scans, MRI when possible, ESR/CRP, and clinical evaluation for staging. A tumor type resection (bleeding bone/soft tissue) was performed followed by the use of antibiotic bead spacers. After antibiotic therapy, reconstruction was performed. Inclusion criteria were all chronic or posttraumatic Cierny-Mader type III and IV infections. The treatment for patients was either suppression or attempted ablation. Patients were evaluated clinically, radiographically, and with laboratory values of ESR/CRP. Ablation was defined as the normalization of laboratory parameters, clinical and radiographic absence of infection, and a salvaged limb. In the cases of suppression, continued antibiotic usage was considered necessary and did not define a failed result. Failure was the persistence or re-emergence of infection. Primary amputations were not included, but amputations after attempted ablation/suppression were considered failures. Statistical analysis was performed using chi square analysis and logistic regression. For the first time period (group I), the antibiotic management was handled by the consulting staff on call for infectious diseases. In the second time period (group 2), a dedicated infectious disease specialist co-managed the patients with a more intense approach to antibiotic regimens and postoperative management. The orthopaedic and infectious disease team saw patients together in the office. Results: We identified 70 patients with posttraumatic osteomyelitis. The skeletal sites in group I included humerus, 3; radius, 2; pelvis, 5; femur,12; tibia, 19; calcaneus, 2; and in group II, humerus,1; radius, 1; pelvis, 5; femur, 5; tibia, 12; and calcaneus, 3. There were 43 patients in group I (non-team) and 27 patients in group II (orthopaedic and infectious disease team). There was no change in the surgical protocol or technique, and the most noteworthy difference was a more refined and prolonged antibiotic regimen. Oral antibiotics were administered for between 3 and 16 months during the healing of the reconstructive phase of treatment to minimize occult seeding of implants and grafts during the revascularization of the reconstructed elements. There were 18 of 43 (42%) successful treatments in group I compared with 21 of 27 (78%) in group II ( P <0.003). Stratification was then done by infection type and host class. Of type III cases, there were 13 of 23 (56%) successes in group I and 9 of 10 (90%) in group II ( P <0.065). For type IV cases, there were 5 of 20 (25%) successes in group I and 12 of 17 (71%) in group II ( P <0.003). When stratified by host class B-local hosts, there were 11 of 22 (50%) successes in group I and 12 of 15 (80%) successes in group II (**). For type B-systemic/local hosts, there were 3 of 13 (23%) successes in group I and 6 of 8 (75%) successes in group II (**). For C hosts, there were 4 of 8 (50%) successes in group I and 3 of 4 (75%) successes in group II (**). Of the 25 patients with failed treatment in group I, 7 went on to either amputation or chronic suppression. The 18 remaining treatment failures had evidence of ongoing and active osteomyelitis and were subsequently treated by the dedicated orthopaedic/infectious disease team separately. Fourteen of these 18 patients went on to successful treatment. Of the six failed treatments in group II, two had amputation, three have ongoing treatment for an aseptic nonunion, and one is chronically suppressed. Discussion: Our results offer an interesting insight into the management of difficult skeletal infections. The main paradigm shift was a more involved and dedicated infectious disease specialist. Multi-drug regimens were implemented that were synergistic and of longer duration of treatment, based on surgical, clinical, laboratory, and radiographic information. The impact of the team approach was especially noted with more severe infections (type IV) and with compromised hosts (B-sys/loc). Although, more expensive in terms of antibiotic usage, the savings in cost may be realized by the efficacy of treatment (fewer hospitalizations, less lost time from work, fewer surgical procedures, etc.). We recognize that the existing literature recommends the need for shorter duration of antibiotic treatment, but we have not been able to duplicate successful results with such a regimen. Furthermore, the patients we treated often had more extensive and established infections, requiring greater resections and more extensive reconstructions. On the basis of our findings, we believe that the team approach to skeletal infections facilitates care for both the patients and the providers. Further study is warranted. Group 1    B-local  B-sys/local  C    Type III   11/14   2/7   0/2  13/23*  Type IV   0/8   1/6   4/6  5/20**    11/22 3/13   4/8  18/43*** Group 2    B-local  B-sys/local  C    Type III   4/5   4/4   1/1  9/10*  Type IV   8/10   2/4   2/3  12/17**    12/15  6/8  3/4  21/27*** * Type III: Group I vs. group II, P <0.065, odds ratio 6.92 (0.89, 54.0) ** Type IV: Group I vs. group II, P <0.006, odds ratio 7.2 (1.75, 29.62) *** Overall: Group I vs. group II, P <0.003, odds ratio 4.86 (1.68, 14.03)

OTA 2002 - Session 2 Session II - Post-Traumatic Reconstruction Fri., 10/11/02 Post Traumatic Reconstruction, Paper #11, 3:19 PM *The Treatment of Complex, Recalcitrant Long-Bone Nonunion with a Human Recombinant Bone Morphogenic Protein: Results of a Prospective Pilot Study Michael D. McKee, MD, FRCS(C) ; Emil H. Schemitsch, MD, FRCS(C); Lisa Wild, BScN; James P. Waddell, MD, FRCS(C); St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada (a-Stryker Biotech, Inc.) Purpose: We sought to determine the safety and efficacy of a human recombinant osteogenic protein (rhBMP-7) in the treatment of recalcitrant human long-bone nonunion. Methods: In a prospective pilot study, we identified 15 patients with complex, recalcitrant long-bone nonunion whose previous treatment was unsuccessful. There were nine men and six women with a mean age of 52.8 years (range, 38 to 76). The involved bones included five tibiae, four clavicles, four humerii, and two femora. All patients had radiographic nonunion, and had had a mean of 2.8 prior unsuccessful operative procedures (range, 0 to 6). Eleven patients had received prior autogenous bone grafting in an attempt to promote union. All patients underwent removal of any previously implanted hardware, debridement of the nonunion, correction of deformity, stable internal fixation, and addition of the rhBMP-7 compound to the nonunion defect. Results: The mean follow-up was 22 months (range, 6 to 52), and no patient was lost to follow-up. The nonunion of 13 patients healed at a mean of 11 weeks postoperatively, and all demonstrated abundant bone formation. The tibia of one patient developed a recurrence of deep infection and required below-knee amputation. One patient with a segmental clavicular defect had delayed radiographic union at the 6-month follow-up but had progressive bone formation, was clinically stable, and declined further intervention. Technically, the rhBMP-7 bone substitute was easy to handle and simple to apply, and there were no adverse clinical events related to its use. Patient satisfaction was high. Conclusions: The bone substitute was technically feasible to use, was not associated with any adverse events, and promoted union in 13 of 15 (87%) patients with refractory long-bone nonunion that had not responded to conventional bone grafting. As part of a standard protocol, this bone graft substitute appears to be safe and effective in providing sufficient biological stimulation for bony union to occur in this difficult-to-treat patient population. Its use eliminates the requirement for autogenous grafting.