Outcome of management with poly-sling versus figure-of-eight brace in patients with mid-clavicular fracture

INTRODUCTION

Two to ten percent of all fractures are clavicle fractures.^[1] Every year, 1 in 1000 persons suffer a clavicle fracture.^[2] About two-thirds of all clavicle fractures occur in males, making them the most frequent fractures among children. Males under 25 (due to sports injuries) and patients over 55 (resulting from falls) account for the two peaks in the bimodal distribution of clavicle fractures.^[1,2] More than one-third of boys and 20% of girls with clavicular fractures are between the ages of 13 and 20. Sixty-nine percent of clavicle fractures occur in the middle third, 28% in the distal third, and 3% in the proximal third.^[2]

Ninety-five percent of pediatric fractures occur in the middle region of the clavicle. Most of these are displaced in children over ten, although they are often non-displaced in children under that age. Ninety-five percent of fractures observed after birth are clavicle fractures.^[3,4]

The gold standard of therapy for mid-clavicle fractures is non-operative treatment.^[4] As reported in Sahu et al. and Rowe papers, in which they examined 2000 patients with a very low nonunion rate of 0.13% and an observed nonunion rate of 0.8% in midshaft clavicle fractures, respectively, served as the basis for their proposal to manage such fracture with poly-sling [Figure 1].^[5,6] Acute displaced middle third clavicle fractures are typically effectively treated non-operatively with good to very good outcomes; however, when conservative measures fail, surgery is the preferred course of action.

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Figure 1:

Poly-sling.

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Research has indicated that patients treated with poly-sling have less discomfort than those treated with figure-of-eight braces [Figure 2].^[6,7] In Mumbai, India, a prospective randomized experiment was carried out to assess the outcomes of conservative treatment of mid-clavicular fractures utilizing the broad-arm sling and figure-of-eight brace. The study comprised 296 patients with middle-third clavicle fractures; 144 patients were treated with a broad arm sling, and 152 patients were treated with a figure-of-eight brace. Fifty-eight percent had a displaced fracture, with a mean age of 33.28 ± 10.73 years. In Group 2 (poly-sling), 67% of participants had a displaced fracture, with a mean age of 29.6 years (standard deviation 1.8). Group 1’s Visual Analog Score (VAS) was 3.4, while Group B’s was 2.7.^[6] In a study by Ersen et al.,^[7] the VAS was 6.8 ± 1.7 in the brace group and 5.6 ± 1.85 in the sling group. Another study assessed the degree of shoulder range of motion restriction, and no noticeable difference was found between the groups (P = 1.00).^[8]

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Figure 2:

Figure-of-eight brace.

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Our institution does not have a standardized protocol for the type of immobilization that should be used for clavicle fractures. In our institution, the surgeon’s preferences, rather than the available data, determine the type of immobilization. This study aimed to compare the use of a figure-of-eight brace and a poly-sling for treating mid-clavicular fractures in terms of pain score on the affected side.

MATERIALS AND METHODS

This randomized controlled trial was conducted in the Department of Orthopedics, Medical Teaching Institute, Lady Reading Hospital, Peshawar, Pakistan, from August 2023 to February 2024. We conducted this study on 68 patients aged 20–60, both sexes, presenting with closed mid-clavicular non-pathological fractures with intact neurovascular bundles of <7-day duration, divided equally into two groups. Group A was treated with a figure-of-eight brace, while Group B had a poly-sling. To reduce selection bias, the sampling was randomized with sealed opaque envelopes. The sample size was calculated using the World Health Organization calculator, with a 95% confidence interval and 80% power of the study, based on a sling group VAS of 5.6 ± 1.85 and a VAS of 6.8 ± 1.7 in the brace group.^[7] Expected are 34 patients in each group, totaling 68 patients. We compared the intensity of pain using the VAS in both groups.

Patients who met the inclusion criteria were enrolled in the Orthopedic Department after receiving clearance from the hospital’s ethical board. After outlining the study’s goal, formal informed consent was obtained. Age, sex, and length of injury were among the demographic details recorded. A thorough medical history was taken, and a physical examination was conducted to identify any additional issues. Using block randomization, patients were randomly assigned to two groups. The figure-of-eight brace was used to treat the patients in Group A. For 3 weeks, the figure-of-eight brace was worn and properly tightened. Patients and family members received education on the importance of consistently tightening the brace. It is necessary to modify the figure-of-eight brace to force the shoulder back into an arched posture.

Simple actions were permitted, and the dominant hand was kept free with the figure-eight brace. For 3 weeks, Group B received a normal broad arm sling. To prevent elbow stiffness, patients were instructed to flex and extend their elbows 4 times a day for 10 min while their upper limbs were immobilized in internal rotation with a sling. Both groups received paracetamol to relieve their discomfort. A follow-up was done at 3 weeks to assess their range of motion and VAS score. Data were entered into a pro forma that was specifically created. The Statistical Packages for the Social Sciences version 22.0 was utilized for data entry and analysis.

RESULTS

This study was conducted on 68 patients with middle-third clavicle fractures divided into two groups. In Group A (figure-of-eight brace), the mean age of patients was 37.94 ± 11.281 years. The mean duration of injury was 3.03 ± 1.507 days. The mean range of motion was 79.38 ± 6.840°. In Group B (poly-sling), the mean age of patients was 38.74 ± 10.264 years. The mean duration of injury was 3.44 ± 1.307 days. The mean range of motion in this group was 78.94 ± 5.789° [Table 1]. In Group A, there were 23 (67.6%) male patients and 11 (32.4%) female patients. In Group B, there were 20 (58.8%) male patients and 14 (41.2%) female patients. In Group A, the mean pain score on VAS was 7.24 ± 0.955, while in Group B, the mean pain score on VAS was 5.44 ± 1.186 (P = 0.0001). In Group A, the pain as measured by VAS was significantly higher than in Group B. The stratification of the comparison of pain (VAS) between the two groups, with respect to age, sex, and duration of injury, is presented in Tables 2-4.

DISCUSSION

Clavicle fractures are frequent injuries that can seriously impair shoulder function, especially in younger people. Because middle-third clavicle fractures, in particular, tend to heal with the right support and immobilization, they are frequently treated conservatively.^[9,10] The results of these two approaches were compared in our study, emphasizing functional recovery, range of motion, and pain levels.^[11-13] On the other hand, Craig^[14] has reported that poly-sling permits some shoulder joint movement, which may lessen stiffness and encourage early mobility, improving the overall healing process.^[14]

Our findings show that the two groups pain levels differed significantly. On the VAS, patients in the poly-sling group reported an average pain score of 5.44 ± 1.186, which was significantly lower than the mean pain score of 7.24 ± 0.955 recorded in the figure-of-eight brace group. This difference is statistically significant, as indicated by the P = 0.0001, indicating that the poly-sling causes less discomfort than the figure-of-eight brace.^[15] This is an important factor to consider when evaluating clavicle fracture treatment options, as effective pain management is crucial for achieving better patient outcomes.^[16]

Since the shoulders are major areas of stiffness with the figure-of-eight brace, the poly-sling is less restricting and applies less pressure to them, which is probably why the poly-sling group experienced lower pain levels. In the early stages of healing, patients who experience less pain are likely to be more comfortable, which can make the experience more favorable overall and potentially lead to better functional recovery results.^[17]

It is plausible to anticipate that the poly-sling group may have a faster return to normal function, especially in the first several weeks following fracture healing, based on prior studies. However, our data did not precisely evaluate the range of motion or duration to full recovery.^[18]

In addition, compared to the figure-of-eight brace, which can be more challenging for patients to wear comfortably and modify, the poly-sling is usually simpler to use and lighter. The strain across the shoulders may be painful, particularly at the beginning of therapy, and the figure-of-eight brace often requires more frequent adjustments to maintain correct alignment. In comparison, the poly-sling offers a more straightforward and pleasant option that may improve patient adherence to treatment. Patients could thus be more inclined to follow the suggested immobilization schedule and participate more efficiently in rehabilitative activities when the immobilization phase is over.^[19]

Overall, our research indicates that poly-sling is the better choice, especially when it comes to pain control and patient comfort for the treatment of middle-third clavicle fractures. The poly-sling group’s reduced pain scores, simplicity of usage, and potential for improved early mobility make it a great option for treating these fractures. In addition, by reducing discomfort and promoting early rehabilitation, the poly-sling may enhance overall results and provide patients with a more satisfying recovery experience. Because of these benefits, poly-sling is the recommended treatment for middle-third clavicle fractures.^[20]

The study involves only 68 patients, which is a relatively small sample size. This may limit the generalizability of the findings to a larger population. Pain was measured using the subjective VAS, which varied based on individual pain tolerance and reporting. The study focused on immediate or short-term outcomes (such as pain and range of motion), but it did not explore long-term effects or complications. The study was conducted in a single medical center, which may limit its ability to capture variations in treatment outcomes across different healthcare settings. It also lacks long-term follow-up and randomization in the sampling process.

CONCLUSION

Patients treated with poly-sling demonstrated a notable improvement in pain levels with mid-clavicular fractures. This finding suggests that poly-sling may offer superior pain management and enhanced comfort for individuals suffering from this type of injury. By prioritizing patient outcomes and comfort, the use of poly-sling represents a more effective and valuable alternative to traditional figure-of-eight braces in managing such fractures.