AimsRecent studies of nonoperatively treated displaced midshaft clavicular fractures have shown a high incidence of nonunion and unsatisfactory functional outcome. Some studies have shown superior functional results and higher rates of healing following operative treatment. The aim of this study was to compare the outcome in these patients after nonoperative management with those treated with fixation.Patients and MethodsIn a multicentre, parallel randomized controlled trial, 146 adult patients with an acute displaced fracture of the midthird of the clavicle were randomized to either nonoperative treatment with a sling (71, 55 men and 16 women with a mean age of 39 years, 18 to 60) or fixation with a pre-contoured plate and locking screws (75, 64 men and 11 women with a mean age of 40 years, 18 to 60). Outcome was assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) Score, the Constant Score, and radiographical evidence of union. Patients were followed for one year.ResultsA total of 60 patients in the nonoperative group and 64 in the operative group completed one-year follow-up. At three months’ follow-up, both the median DASH (1.7 vs 8.3) and median Constant scores (97 vs 90) were significantly better in the operated group (both p = 0.02). After six months and one year, there was no difference in the median DASH or Constant scores. The rate of nonunion was lower in the operative group (2 vs 11 patients, p < 0.02). Nine patients in the nonoperative group underwent surgery for nonunion. The plate was subsequently removed in 16 patients (25%). One patient had a new fracture after removal of the plate and one underwent revision surgery for failure of fixation.ConclusionFixation of a displaced midshaft clavicular fracture using a pre-contoured plate and locking screws results in faster functional recovery and a higher rate of union compared with nonoperative management, but the function of the shoulder is equal after six months and at one year. Cite this article: Bone Joint J 2018;100-B:1385–91.
Background: Frozen shoulder is a painful joint disease. Patients with diabetes seem to have worse clinical symptoms and surgery in this patient population is believed to be more common. The objective postoperative evaluation indicates inferior results when surgically treating diabetics, but no previous studies have investigated exclusively the subjective patient satisfaction with arthroscopic capsular release. Materials and methods: A total of 93 patients were included. All had persistent symptoms despite conservative treatment for at least six months. The patients were retrospectively divided into two groups based on diabetes status: Group 1 consisted of patients with type 1 or type 2 diabetes (18) and group 2 consisted of the remaining patients (75). Evaluation was performed prior to arthroscopic capsular release and at six months follow-up. The web-based questionnaire consisted of two different evaluation forms: The Oxford Shoulder Score (OSS) and a visual quality scale (VQS). Results: Both groups reported a statistically significant improvement in both evaluations. OSS in group 1 improved by 11.5 [95% CI: 6.2 ; 16.4] and by 15.8 [95% CI: 13.6 ; 17.9] in group 2. The improvement was more pronounced in group 2, though not statistically significant (p = 0.09). The VQS improved 39.6 in group 1 and 44.5 in group 2, (p = 0.50). Conclusion: Diabetic and non-diabetic patients reported equal symptom relief after arthroscopic capsular release of frozen shoulder when selected for operation without considering diabetic status. We will continue to select patients for arthroscopic release without differences in preoperative counseling between diabetics and non-diabetics.
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.
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