The purpose of this study was to evaluate the efficacy of human recombinant osteogenic protein 1 (rhBMP-7) for the treatment of fracture non-unions and to estimate the health economics aspect of its administration. Twenty-four patients (18 males, mean age 39.1 (range 18-79)) with 25 fracture non-unions were treated with rhBMP-7 in our institution (mean follow-up 15.4 months (range 6-29)). Successful completion of treatment was defined as the achievement of both clinical and radiological union. The cost of each treatment episode was estimated including hospital stay, theatre time, orthopaedic implants, drug administration, investigations, clinic attendances, and physiotherapy treatments. The total cost of all episodes up to the point of receiving BMP-7 and similarly following treatment with BMP-7 were estimated and analysed. Of the 25 cases, 21 were atrophic (3 associated with bone loss) and 4 were infected non-unions. The mean number of operations performed prior to rhBMP-7 application was 3.4, including autologous bone graft in 9 cases and bone marrow injection in one case. In 21 out of the 25 cases (84%), both clinical and radiological union occurred. Mean hospital stay before and after receiving rhBMP-7 was 26.84 days per fracture and 7.8 days per fracture respectively. Total cost of treatments prior to BMP-7 was £346,117 [£13,844.68 per fracture]. Costs incurred following BMP-7 administration were estimated as £183,460 [£7,338.4 per fracture]. rhBMP-7 was used as a bone stimulating agent with or without conventional bone grafting with a success rate of 84% in this series of patients with persistent fracture non-unions. The average cost of its application was £7,338 [53.0% of the total costs of previous unsuccessful treatment of non –unions, p<0.05). Treating non-union is costly, but the financial burden could be reduced by early rhBMP-7 administration when a complicated or persistent non-union is present or anticipated. Therefore, this study supports the view that rhBMP-7 is a safe and power adjunct to be considered in the surgeon's armamentarium for the management of such difficult cases.
The effect of head injury on systemic physiology, including bone healing is still a topic of vivid discussion. We aimed to investigate whether in patients with long bone fractures the presence of head injury is associated with excessive callus formation. Data on patients with head injury and femoral diaphyseal fracture admitted to our trauma unit between 1997- 2002 were collected and analysed. Patients with factors that could influence bone healing such as smoking, NSAIDs and hormonal disorders were excluded. The severity of head injury was quantified using GCS, AIS and CT scan reports. Patients matched for age, sex and ISS with femoral shaft fractures and no head injury formed the control group of the study. All the fractures were stabilised with reamed femoral nail. The quantification of fracture healing response was estimated by taking the radiological ratio of the largest diameter of callus formed into two planes and the adjacent normal diameter of femoral canal. The minimum follow-up of the patients was 12 months. In total 42 patients were studied, 17 with head injury and femoral fracture and 25 with an isolated femoral fracture, (control group). Both groups were comparable in terms of age, sex, ISS. The difference between the mean callus to diaphyseal ratio was statistically significant for both the AP and Lateral projections (AP – mean difference 0.462, 95% CI 0.312 to 0.602, p<0.0001, LAT – mean difference 0.289, 95% CI 0.142 to 0.436, p<0.001) with the head injured patients having more florid callus compared to the control group. This study supports the view that head injury leads to exuberant callus formation in patients with long bone fractures. The mechanisms of this response could be both central and local. Research is ongoing to elucidate the pathways involved in this biological phenomenon.
Guidelines on the care of the seriously injured have led to widespread changes in clinical practice. The ‘hub and spoke’ model of trauma care means increasing numbers of patients with complex problems are concentrated into regional centres. Though providing the highest standards of treatment, this has cost implications for the receiving unit, particularly given the Department of Health's move towards a ‘Payment by Results’ model of health provision. We undertook an economic evaluation of complex limb reconstruction within our tertiary referral unit. Patients referred to the complex trauma service were identified. Patients were assigned to either a ‘complicated’ or ‘straightforward’ group by two consultant surgeons, based on the nature of their treatment. 5 cases from each group were randomly selected for further analysis. Data pertaining to the direct healthcare costs for these patients was analysed. Costs per investigation/intervention were obtained relating to hospital stay, outpatient care, operative interventions and investigations. Overall 26 patients were referred to our complex trauma service from other units over 6 months. A mean of £8,375 (6,163) per patient was recouped using current Service Level Agreements. This amounts to a £26,587 deficit per patient, or £1,394,905 per year assuming current referral rates. Those planning a service treating complex trauma must allow for the considerable costs involved and make provisions to recoup this from the referring Primary Care Trust.
97 grade III open fractures in 95 patients 64 required temporary spanning ex-fix: 23 applied at trauma centre/41 at DGH 14/64 ex-fixes required revision (prior to definitive Ilizarov): poor plastics access(6)/instability(2)/both(6) All 14 revised had been applied in a DGH, i.e. 14/41 DGH ex-fix needed revision (34%) Ex fixes revised after application at trauma centre vs. DGH = 0/23 vs. 14/41, p<
0.01 ×2 Revision of Hoffman hybrid vs. monolateral ex fix = 4/4 vs. 10/60 p<
0.001 ×2 Non modular system (Orthofix) vs. modular systems (Hoffman II/AO) = 7/17 vs. 0/39 p<
0.001
All Hoffman hybrids needed revision, due to both instability and plastics access. Significantly more non modular (Orthofix) ex-fixes required revision compared to modular (Hoffmann II/AO), due to poor plastics access.
- 10/22 participants had not previously attended an ex-fix course. - Pre- vs. post-course score (out of 4) = 2.5 vs. 3.7 (p<
0.001, Mann-Whitney U) - All participants Teaching Hospitals vs. DGHs: - Pre-course scores = 2.9 vs. 1.9 (p<
0.01) - Post-course scores = 3.6 vs. 3.8 (not significant) - Pre-course scores by grade of participant: - SHO vs. Senior SHO = 2.6 vs. 1.5 (p<
0.05) - SpR vs. Senior SHO = 3.0 vs. 1.5 (p<
0.05) - SpR vs. SHO = 3.0 vs. 2.6 (not significant) - Post-course scores by grade: - SpR vs. Senior SHO vs. SHO = 4.0 vs. 3.8 vs. 3.3 (not significant).
Participation in a simple ex-fix course improves knowledge of ex-fix design. Retention of knowledge must be reassessed after several months. This course fills a gap in education of basic external fixation for orthopaedic trainees. We recommend every region with a tertiary referral system for complex trauma utilises this course.
- Ex-fix trays per unit (all manufacturers) mean = 4.14 (1–9) - Majority equipment in unit = Orthofix (11), Hoffman II (5), AO (1) - 12/15 SpRs reported insufficient ex-fix equipment for pelvis, 4 long bones and bridging knees (Damage Control Orthopaedics = DCO) - 7/15 SpRs reported insufficient ex-fix for 4 long bones/ bridging knees
- mean year of training = 2.2 - Experience: Generic trauma course (9) Specific ExFix (6) Manufacturer (9) - 14/15 would value specific regional ex-fix course - DCO patient scenario SpR unable to fix -lack of knowledge vs. lack of equipment 7/15 vs. 12/15 p<
0.01
- 7/31 aware of transfer protocol - 31/31 want referral routes clearly identified - 12/15 would value regular regional audit
All trainees had attended ex-fix teaching. Those who had only attended generic courses were less confident in DCO scenarios. Most favoured a specific regional ex-fix course. Tertiary care protocols have been distributed, but many units are unaware of their existence. A regular regional audit of trauma referrals would provide protocol reinforcement and opportunity for feedback.
- 97 grade III open fractures in 95 patients - 64 required temporary spanning ex-fix: - 23 applied at trauma centre / 41 at DGH - 14/64 ex-fixes required revision (prior to definitive Ilizarov): - poor plastics access (6) / instability (2) /both (6) - All 14 revised were applied in a DGH, i.e. 14/41 DGH ex-fix needed revision (34%) - Ex fixes revised after application at trauma centre vs. DGH = 0/23 vs. 14/41, p<
0.01 X2 - Revision of Hoffman hybrid vs. monolateral ex fix = 4/4 vs. 10/60 p<
0.001 X2 - Non modular system (Orthofix) vs. modular systems (Hoffman II / AO) = 7/17 vs. 0/39 (p<
0.001)
All Hoffman hybrids needed revision, due to instability and plastics access. Significantly more non modular (Orthofix) ex-fixes required revision compared to modular, for poor plastics access. We recommend modular external fixator application (Hoffman II or AO) to avoid problems with temporary external fixation of open tibial fractures. Hybrid temporary external fixation should be abandoned in such injuries.
Gustilo grade, 3A/3B/3C = 6/13/2. Both 3C fractures required early amputation. Wound closure, 5/6 fractures with bone loss required free tissue transfer (FTT); however only 3/15 fractures without bone loss required FTT to achieve soft tissue cover, most requiring fasciocutaneous flap or split skin graft only. Median time in Ilizarov frame was 160 days for patients without bone loss. For those fractures with bone loss frame time ranged from 180–540 days, with some patients still requiring ongoing Ilizarov treatment. All fractures without bone loss united. At mean 14 month follow up only one fracture of 21 had clinical evidence of deep sepsis. 1 tibial fracture showed a 12 degree malunion, while 7/18 patients had a superficial pinsite infection requiring a course of oral antibiotics. One free tissue transfer failed in a grade 3C fracture, leading to early amputation (in conjunction with the recognised vascular injury).
Flap and Frame appears to be a very satisfactory method of treating grade 3 open fractures, with low deep sepsis rate, high union rate, satisfactory times to union, and reduced requirement for free tissue transfer to obtain soft tissue coverage.