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Intramedullary nailing in open tibia fractures: a comparison of two techniques |
Ziran B H, Darowish M, Klatt B A, Agudelo J F, Smith W R |
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Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. Health technology Patients with open tibia fractures were treated with intramedullary nailing, which was performed using the "reamed-to-fit" (RTF) method. A comparator group of patients had their open tibia fractures treated with nailing without reaming. All the fractures were assigned a Gustilo grade. All open fractures received early antibiotic treatment. Gustilo I and II fractures were treated with cefazolin, while patients allergic to penicillin were given clindamycin. Grade IIIa fractures received cefazolin and gentamicin. Grade IIIb and IIIc fractures received 2 mU of intravenous penicillin in addition to cefazolin and gentamicin. The RTF approach also used antibiotic-impregnated beads for Grade IIIb open fractures before tissue coverage was obtained.
Economic study type Cost-effectiveness analysis.
Study population The study population comprised patients with open tibia fractures attending one hospital. Patients were excluded from the study if the fractures were within the distal one-fifth of the bone and within the proximal one-fourth.
Setting The setting was secondary care. The economic study was carried out in the USA.
Dates to which data relate The dates to which the effectiveness and resource evidence related were not reported. The price year was not given.
Source of effectiveness data The effectiveness data were derived from a single study.
Link between effectiveness and cost data The same patients provided the effectiveness data and cost data. The costing appears to have been carried out retrospectively.
Study sample No power calculations were reported. There was no sample selection. There were 51 patients in the study, 22 in the RTF group and 29 in the no reaming (NR) group.
Study design Patients were allocated to the treatment group depending on the day they needed treatment and which of the two surgical teams was on duty that day, as each team carried out one of the treatments. The duration of follow-up was 24 months.
Analysis of effectiveness The basis of the analysis was treatment completers only. The following health outcomes were used:
the percentage healed at 12, 18 and 24 months;
the number of supplementary procedures;
the number of secondary procedures;
the number of patients suffering from infections; and
the number of screw failures.
The authors stated that the two patient groups were comparable in terms of demographic and medical data, but they only gave evidence on the mean age, gender composition and Gustilo fracture score in the two groups. There appears to have been important differences in the Gustilo fracture scores between the two groups.
Effectiveness results Twenty-one of the 22 patients in the RTF group and 28 of the 29 patients in the NR group had their fractures heal.
The healing rate was 73% in the RTF group and 85% in the NR group at 12 months, 82% (RTF group) and 92% (NR group) at 18 months, and 95% (RTF group) and 96% (NR group) at 24 months. The differences in healing rates were not statistically significant.
There were 11 supplemental procedures in the RTF group and 28 in the NR group.
The number of secondary procedures was greater in the NR group (32) than in the RTF group (11), (p<0.05).
Infections developed in 2 of the RTF group and 7 of the NR group.
There were 3 screw failures in the NR group and 1 in the RTF group.
There was 1 amputation in each group.
Clinical conclusions The authors concluded that although there was no clear difference between the healing rates in the two groups, the patients in the RTF group had to undergo fewer supplemental and secondary procedures, and also suffered fewer infections. Thus, the authors argued that there appears to be an advantage for patients if reaming-to-fit is carried out.
Measure of benefits used in the economic analysis No summary measure of benefits was produced. In effect, the authors carried out a cost-consequences analysis.
Direct costs No discounting was carried out since the costs were incurred during less than 2 years. The quantities and the costs were not analysed separately. Operating room, surgical and anaesthesia costs were included. The costs were estimated using actual data obtained from the hospital. No dates for the quantities were given. No price year was reported.
Statistical analysis of costs No statistical analysis of the costs was carried out.
Indirect Costs No indirect costs were estimated.
Sensitivity analysis No sensitivity analysis was carried out.
Estimated benefits used in the economic analysis Since a cost-consequences analysis was conducted, the reader is referred to the 'Effectiveness Results' section.
Cost results The mean cost of the RTF technique was $3,600, while that of the non-reamed technique was $8,500.
It appears that all surgical, operating room and anaesthesia costs have been included for 2 years after the initial operation, but other hospital and health care costs were not included. Thus, only the surgical, operating room and anaesthesia costs resulting from adverse events would appear to have been included.
Synthesis of costs and benefits The costs and benefits were not combined as the study was, in effect, a cost consequences analysis. The RTF technique was the dominant strategy (more effective and less costly).
Authors' conclusions The reamed-to-fit (RTF) technique used in the study dominated the non-reamed technique for patients with open tibia fractures. This is because it cost less and resulted in fewer supplementary procedures and fewer infections.
CRD COMMENTARY - Selection of comparators The selection of the comparator (nailing without reaming) was implicitly justified by it often representing current practice. You should decide whether it represents current practice in your own setting.
Validity of estimate of measure of effectiveness The effectiveness data were obtained from a single study in which treatment depended on which surgeon was in charge of the case. The study design was not, therefore, ideal as the patients were not randomly selected to receive the different treatment. Although the authors stated that the two patient groups were comparable, they did not provide sufficient data to show this. Moreover, the data on Gustilo fracture grade suggested that the two groups were not comparable. Since details on the study sample were limited, it was not certain that the study sample was representative of the study population. However, all adult patients meeting the inclusion criteria were included, so they probably are representative. Apart from these factors the analysis of effectiveness was handled credibly.
Validity of estimate of measure of benefit The authors did not derive a summary measure of health benefit. The study was, in effect, a cost-consequences analysis. Therefore, the comments in the 'Validity of estimate of measure of effectiveness' field (above) apply.
Validity of estimate of costs >From the cost perspective adopted (i.e. the hospital), not all of the relevant categories of cost were included. However, if all of the non-operating room costs had been included, this would have probably strengthened the authors' conclusions that the RTF technique cost less, as it involved fewer supplemental and secondary procedures. The costs and the quantities were not reported separately. The resource use quantities were taken from a single study, while the prices were taken from the authors' setting. No other sources were used for the resource quantities. No statistical, sensitivity, or any other kinds of analyses of the quantities or prices were conducted. In addition, the price year was not reported, which inhibits reflation exercises. These aspects of the study indicate that the cost results should be treated with some caution.
Other issues The authors compared their results with the findings from other studies. The issue of generalisability to other settings was not addressed. The authors did not present their results selectively and their conclusions reflected the scope of the analysis. Limitations of the study were noted. For example, the authors acknowledged that their sample size was too small for the differences in infection rate to be statistically significant, and that the patients were not randomly allocated to the two treatment groups. In addition, the use of antibiotic beads might have reduced the rate of infection in the reamed group; this may partially account for the difference in infection rate.
Implications of the study There is a need for a large-scale randomised trial to evaluate RTF techniques. Such a trial should consider all of the health care costs of the two kinds of treatment,
Bibliographic details Ziran B H, Darowish M, Klatt B A, Agudelo J F, Smith W R. Intramedullary nailing in open tibia fractures: a comparison of two techniques. International Orthopaedics 2004; 28(4): 235-238 Indexing Status Subject indexing assigned by NLM MeSH Adolescent; Adult; Aged; Female; Fracture Fixation, Intramedullary /methods; Fractures, Open /surgery; Humans; Male; Middle Aged; Tibial Fractures /surgery; Treatment Outcome AccessionNumber 22004001116 Date bibliographic record published 30/09/2005 Date abstract record published 30/09/2005 |
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