Introducing the Surgical Therapeutic Index in trauma surgery: an assessment tool for the benefits and risks of operative fracture treatment strategies.

BACKGROUND: The Surgical Therapeutic Index (STI) has been described as an indicator of the benefits and risks of surgical treatment. The index is calculated by dividing the cure rate of an operative treatment by the complication rate. This study introduces the STI in trauma surgery by comparing the indices for surgical plate fixation (PF) and intramedullary fixation (IMF) of displaced midshaft clavicular fractures. METHODS: In a previously reported, randomized controlled fashion, 120 patients were assigned to PF or IMF. Cure was defined by a Disabilities of the Arm, Shoulder and Hand score of 8 or less. Complications were noted as present or not present for each follow-up assessment, and a panel of experts provided weights to the severity of complications. STIs were reported along with their 95% confidence intervals. The higher a procedure's STI, the higher the benefit/risk balance of that procedure. RESULTS: The nonweighted STI after 6 weeks was significantly higher in the PF group. During further follow- up, the differences leveled out and became nonsignificant. When weighting the STI for severity, the indices decrease but are significantly in favor of the PF group at 6 weeks and 6 months after surgery. At 1 year postoperatively, differences are not significant. CONCLUSION: The STI may be a reliable tool to assess the benefits and risks of operative fracture treatment. Further studies with consistent results of this new scoring system are needed before conclusions can be generalized. When determining the indices of PF and IMF, a significant difference in favor of PF was observed during the early phase of recovery.

Operative treatment of dislocated midshaft clavicular fractures: plate or intramedullary nail fixation? A randomized controlled trial.

BACKGROUND: Over the past decades, the operative treatment of displaced midshaft clavicular fractures has increased. The aim of this study was to compare short and midterm results of open reduction and plate fixation with those of intramedullary nailing for displaced midshaft clavicular fractures. METHODS: A multicenter, randomized controlled trial was performed in four different hospitals. The study included 120 patients, eighteen to sixty-five years of age, treated with either open reduction and plate fixation (n = 58) or intramedullary nailing (n = 62). Preoperative and postoperative shoulder function scores and complications were documented until one year postoperatively. Significance was set at p < 0.05. RESULTS: No significant differences in the Disabilities of the Arm, Shoulder and Hand (DASH) or Constant-Murley score (3.0 and 96.0 points for the plate group and 5.6 and 95.5 points for the nailing group) were noted between the two surgical interventions at six months postoperatively. Until six months after the surgery, the plate-fixation group experienced less disability than the nailing group as indicated by the area under the curve of the DASH scores for this time period (p = 0.02). The mean numbers of complications per patient, irrespective of their severity, were similar between the plate-fixation (0.67) and nailing (0.74) groups (p = 0.65). CONCLUSIONS: The patients in the plate-fixation group recovered faster than the patients in the intramedullary nailing group, but the groups had similar results at six months postoperatively and the time of final follow-up. The rate of complications requiring revision surgery was low. Implant-related complications occurred frequently and could often be treated by implant removal.

Systematic review of complications after intramedullary fixation for displaced midshaft clavicle fractures.

BACKGROUND: The number of displaced midshaft clavicle fractures treated surgically is increasing, and open reduction and intramedullary fixation is an emerging surgical treatment option. The study quality and scientific levels of published evidence in which possible complications of this treatment are presented vary greatly. METHODS: We performed systematic computer-based searches of EMBASE and PubMed/MEDLINE. Studies included for review reported complications after intramedullary fixation alone or in comparison to either treatment with plate fixation and/or nonoperative treatment. The Level of Evidence rating and Quality Assessment Tool were used to assess the methodological quality of the studies. Included studies were ranked according to their levels of evidence. RESULTS: Six articles were eligible for inclusion and final quality assessment; 3 studies were graded the highest level of evidence. Major complications like bone-healing problems and deep infections requiring implant removal were reported at a rate no higher than 7%. Reported rates for minor complications, such as wound infection and implant irritation that could be resolved without further surgery, were as high as 31%. CONCLUSION: The noted rates for major complications requiring additional surgery were low, but implant-related problems that require additional surgery might present with high prevalence. Owing to routine implant removal, treatment with intramedullary fixation often requires an additional surgical procedure.

Systematic review of the complications of plate fixation of clavicle fractures.

BACKGROUND: The number of displaced midshaft clavicle fractures treated surgically is increasing and plate fixation is often the treatment modality of choice. The study quality and scientific levels of evidence at which possible complications of this treatment are presented vary greatly in literature. PURPOSES: The purpose of this systematic review is to assess the prevalence of complications concerning plate fixation of dislocated midshaft clavicle fractures. METHODS: A computer-based search was carried out using EMBASE and PUBMED/MEDLINE. Studies included for review reported complications after plate fixation alone or in comparison to either treatment with intramedullary pin fixation and/or nonoperative treatment. Two quality assessment tools were used to assess the methodological quality of the studies. Included studies were ranked according to their levels of evidence. RESULTS: After study selection and reading of the full texts, 11 studies were eligible for final quality assessment. Nonunion and malunion rates were less than 10% in all analysed studies but one. The vast majority of complications seem to be implant related, with irritation or failure of the plate being consistently reported on in almost every study, on average ranging from 9 to 64%. CONCLUSION: The quantity of relevant high evidence studies is low. With low nonunion and malunion rates, plate fixation can be a safe treatment option for acute dislocated midshaft clavicle fractures, but complications related to the implant material requiring a second operation are frequent. Future prospective trials are needed to analyse the influence of various plate types and plate position on implant-related complications.