Minimal Pain Decrease Between 2 and 4 Weeks After Nonoperative Management of a Displaced Midshaft Clavicle Fracture Is Associated with a High Risk of Symptomatic Nonunion.

BACKGROUND: The main long-term benefit of operative treatment of displaced midshaft clavicular fractures is the reduction in nonunion risk, and as this risk is generally low, the ideal approach would be to operate only patients at high risk of nonunion. However, most current surgical decision models use baseline variables to estimate the nonunion risk, and the value of these models remains unclear. Pain in the early weeks after fracture could be potentially be an indirect measurement of fracture healing, and so it is a potential proxy variable that could lead to simpler prediction models. QUESTIONS/PURPOSES: (1) Is pain a possible proxy variable for the development of symptomatic nonunion after nonoperative treatment of midshaft clavicular fractures? (2) How reliable is the model we created that uses pain as a proxy variable for symptomatic nonunion of nonoperatively treated clavicle fractures? METHODS: In this secondary retrospective analysis of an earlier randomized trial, we studied prospectively collected data from 64 nonoperatively treated patients aged 18 years to 60 years. In the original randomized trial, we compared operative and nonoperative treatment of displaced midshaft clavicular fractures. In all, 150 patients were included in the study, of whom 71 received nonoperative treatment. Patients were predominantly males (75%, 48 of 64) with a mean age of 38 ± SD 12 years; most fractures were comminuted and shortened more than 1 cm. All 71 patients who were nonoperatively treated were potentially eligible for this secondary analysis; of those, 11% (8 of 71) were lost to follow-up, leaving 63 patients from the nonoperative treatment arm and one patient from the operative treatment arm (who declined surgical treatment after randomization but was followed in this group according to the intention-to-treat principle) for analysis here. Nonunion was defined as lack of callus formation, persistent fracture lines and/or sclerotic edges of the bones at the fracture site on plain radiographs at 6 months follow-up. Nonunions were regarded as symptomatic if pain, tenderness, and local crepitation were present at the fracture site. Seventeen percent (11 of 64) of patients had symptomatic nonunions. After investigating differences in early pain scores between the union and nonunion groups, we defined the VASratio as the VAS pain score at 4 weeks divided by the VAS pain score at 2 weeks. Week 2 VAS pain score was chosen as baseline after visual inspection of a linear mixed model that showed increased divergence in pain scores between union and nonunion group at 2 weeks after fracture. Week 4 was chosen as the cutoff because we wanted a reasonable time frame for the detection of pain reduction and did not want to delay surgical treatment more than necessary. Odds ratios for various risk factors were calculated using logistic regression analyses. We used a receiver operating characteristic curve analysis to identify cutoff values for the VASratio. RESULTS: An increase in absolute pain score at 4 weeks after fracture (odds ratio 1.8 per 1 point increase [95% confidence interval 1.1 to 3.4]) was associated with an increased risk of nonunion 6 months after fracture. Likewise, we found that an increasing VASratio (OR 1.02 per 0.01 point increase [95% CI 1.002 to 1.06]) was also associated with nonunion. Receiver operating curve analysis found that the best cutoff value of VASratio was about 0.6. Patients with a VASratio above 0.6 had a relative risk of developing nonunion of 18 (95% CI 2 to 130) compared with patients with a VASratio below 0.6. Sparse-data bias could be present, as is evident from this wide confidence interval, though even at the low end of the confidence interval, the relative risk was 2, which may still improve surgical decision-making. CONCLUSION: A pain score that exhibits no or minimal change from 2 to 4 weeks after nonoperative treatment of a displaced midshaft fracture of the clavicle is associated with a high risk that symptomatic nonunion will develop. Patients with no or minimal change in pain in the early weeks may be candidates for surgery to reduce the risk of symptomatic nonunion. As this was a retrospective study, with a risk of sparse-data bias, the predictive value of the VASratio needs to be further investigated in large prospective studies before clinical use. LEVEL OF EVIDENCE: Level III, diagnostic study.

Operative treatment of displaced midshaft clavicular fractures is not cost-effective.

BACKGROUND: Conventional treatment of displaced midshaft clavicular fractures is nonoperative. Recent studies have implied that operative treatment might result in a faster return to work, resulting in a decreased productivity loss for society. The cost utility of plate fixation vs. nonoperative treatment of displaced midshaft clavicular fractures has not previously been investigated using a societal perspective. METHODS: Decision analytical modeling of incremental costs and quality-adjusted life-years (QALYs) was performed. Data on utility, hospitalization, and productivity costs were retrieved from a Danish randomized controlled trial. Supplementary data were taken from randomized controlled trials identified in the literature. A 1-year time horizon was applied, and all prices were reported with respect to a 2016 level. RESULTS: Operative treatment was associated with a larger QALY gain in patients and a higher cost compared with nonoperative treatment. The incremental cost-effectiveness ratio (ICER) was estimated in Danish currency (Danish krone [kr]) at kr1,360,000 (€182,306) per QALY from a health-sector perspective and kr1,388,738 (€186,158) per QALY from a societal perspective. Considering a subgroup analysis of patients with a high-load shoulder profession, operative treatment was dominated by nonoperative treatment from a health-sector perspective. Considering a societal perspective, the ICER was estimated at -kr889,091 (-€119,181) per reduction of 1 QALY. One-way and probabilistic sensitivity analyses showed that the results were subject to uncertainty. CONCLUSION: Operative treatment is not cost-effective when considering a threshold of €34,000/QALY. However, for a subgroup of patients with a high-load shoulder profession, operative treatment might be cost-effective compared with nonoperative treatment.

No need to use both Disabilities of the Arm, Shoulder and Hand and Constant-Murley score in studies of midshaft clavicular fractures.

Background and purpose - Most newer randomized studies examining plate fixation and nonoperative treatment of midshaft clavicular fractures utilize both Disabilities of the Arm, Shoulder and Hand (DASH) and Constant-Murley score (CS) in the evaluation of patient outcomes. Compared with DASH, the use of CS requires on-site trained personnel and patient visits to obtain the score. The use of both DASH and CS should provide extra value compared with the use of a single functional outcome score; if this value is not provided, the combined use is not necessary. We evaluated the agreement between DASH and CS in patients with displaced midshaft clavicular fractures.Patients and methods - We used prospectively collected data from 146 patients enrolled in a randomized study comparing operative and nonoperative treatment of midshaft clavicular fractures. We determined correlation between DASH and CS at all follow-up points and calculated mean bias in the Bland-Altman plot.Results - We found moderate to high correlation (from 0.82 at 6 weeks' follow-up to 0.58 at 1-year follow-up) between DASH and CS score, and a small bias (2.21 [95% CI 0.22-4.20]) in the Bland-Altman plot.Interpretation - In patients with displaced midshaft clavicular fractures DASH and CS measures the same degree of disability. Unless specifically studying strength and range of motion, we recommend the sole use of DASH as it would eliminate potential observer-induced bias along with removing the economic and logistic burden of obtaining CS without compromising the value of the collected data.

Minimal early functional gains after operative treatment of midshaft clavicular fractures: a meta-analysis of 10 randomized controlled trials including 1333 patients.

Background: There is substantial evidence that operative treatment reduces the risk of nonunion but offers no long-term functional gains compared with nonoperative treatment. Despite some studies citing quicker recovery with surgery, the promise of accelerated functional recovery remains under-investigated. The aim of this meta-analysis of randomized controlled trials was to investigate the possible early functional gains (≤6 months) after operative treatment of displaced midshaft clavicular fractures compared with nonsurgical treatment. Methods: A systematic search was performed to identify randomized controlled trials comparing plate osteosynthesis with nonoperative treatment. We evaluated shoulder function outcomes measured by Constant Score or Disability of the Arm, Shoulder, and Hand (DASH) questionnaire. Other outcomes of interest were sick leave and return to previous activity (work, leisure). Results: Ten studies including 1333 patients were included. The mean difference in DASH score after 6 weeks was 9.4 points (95% confidence interval [CI] 13.7-5.1) in favor of operative treatment. At 3 months, the difference was 3.6 points (95% CI 6.9-0.4), and at 6 months, the difference was 3.2 points (95% CI 5.2-1.1), both in favor of operative treatment. Results for Constant Score were similar to that of DASH score. Conclusion: This meta-analysis shows that there is an early functional gain at six weeks following plate fixation of midshaft clavicular fractures compared with nonoperative treatment. At three and six months, the functional gain is lesser and not clinically relevant.