Analysis of the efficacy of Endobutton plate combined with high-strength suture Nice knot fixation in the treatment of distal clavicle fractures with coracoclavicular ligament injuries

doi:10.21203/rs.3.rs-4871464/v1

Objective

To investigate the efficacy of Endobutton plate combined with high-strength suture Nice knot fixation in the treatment of distal clavicular fractures with coracoclavicular ligament injuries.

Methods

A retrospective analysis was performed on 43 patients with distal clavicular fractures accompanied by coracoclavicular ligament injuries, who were treated with an Endobutton plate between January 2017 and December 2023. The fracture sites were categorized based on the fixation method employed: high-strength suture Nice knot fixation (experimental group, n = 23) and acromioclavicular Kirschner wire fixation (control group, n = 20). No significant differences were observed in general demographic data, including age, gender, injury etiology, Craig classification, hospitalization duration, visual analog scale (VAS) scores, American Shoulder and Elbow Surgeons (ASES) Scores, and Constant-Murley scores between the two groups (P > 0.05). In addition to tracking postoperative fracture problems and healing, the injured side's increased coracoclavicular space rate was computed. Utilizing the VAS, determine the affected shoulder's pain threshold. to compare the ASES and Constant-Murley ratings for the shoulder joint before and after surgery.

Results

Both patient groups successfully underwent surgery without any significant complications, such as vessel or nerve injury or coracoid fracture. Postoperatively, the control group experienced one case of mild screw tract infection and one case of Kirschner wire displacement. Conversely, the experimental group did not report any significant complications. Both groups were followed up for a period ranging from 12 to 33 months, with an average follow-up duration of (20.53 ± 5.16) months. The fractures in both groups healed, with healing times of (12.82 ± 1.12) weeks and (17.25 ± 1.71) weeks, respectively. This difference was statistically significant (P < 0.05). At the final follow-up, the coracoclavicular space expansion rate was (9.25 ± 2.53) % in the experimental group and (8.10 ± 2.53) % in the control group, with no significant difference observed (P > 0.05). Both groups demonstrated significant improvements in VAS scores, Constant-Murley scores, and ASES scores post-operatively compared to pre-operative values (P < 0.05). The Constant-Murley score and ASES score at one-month post-operation were significantly superior in the experimental group than in the control group, indicating a statistically significant difference (P < 0.05). However, no statistical difference was observed at three months post-operation or during the final follow-up (P > 0.05).

Conclusion

In the management of distal clavicle fractures accompanied by coracoclavicular ligament injuries, particularly oblique fractures or those with butterfly-shaped fragments, the application of a high-strength Nice knot suture in conjunction with Endobutton plate fixation can effectively stabilize the fracture site. This approach not only mitigates complications associated with Kirschner wire fixation but also enhances fracture healing, leading to favorable postoperative outcomes.

distal clavicle fracture

Endobutton plate

coracoclavicular fixation

Kirschner Wire

Nice knot

In clinical practice, clavicle fractures are typically categorized into proximal, mid-shaft, and distal types. Notably, distal clavicle fractures frequently necessitate surgical intervention. These fractures occur in the outer third of the clavicle and are often associated with damage to the coracoclavicular ligament, leading to pronounced displacement and elevated nonunion rates[1, 2]. While numerous fixation techniques exist, each exhibits certain limitations, and a universally accepted gold standard for treatment remains elusive[3–5]. Most distal clavicle fractures result from injury to the coracoclavicular ligament, which is why coracoclavicular ligament reconstruction has been gaining popularity. Additionally, coracoclavicular fixation has good biomechanical qualities[5, 6] and the coracoid process is stronger than the distal clavicle[7]. As a result, in recent years, coracoclavicular suspension fixation has been suggested as a therapy approach[8].

A popular fixation technique for the coracoclavicular joint is the Endobutton plate[9, 10]. However, it only offers vertical stability to the fracture site, making it challenging to manage horizontal displacement. This can lead to delayed or non-union of the fracture and internal fixation failure[2, 11]. Some studies have suggested combining coracoclavicular fixation with percutaneous Kirschner wire fixation of the fracture site. However, this approach can irritate the surrounding skin and presents risks of infection and Kirschner wire displacement[12], hindering early functional shoulder joint exercise. Suture ligation can be used for the reduction and fixation of fractures and small bone fragments. The Nice knot, a high-tension sliding knot with a double-wire structure, can achieve the maximum tension of the suture. Therefore, Nice knot ligation could potentially enhance Endobutton plate coracoclavicular fixation. We conducted a retrospective analysis of the clinical data pertaining to patients with distal clavicle fractures, accompanied by coracoclavicular ligament injuries, who underwent coracoclavicular fixation using an Endobutton plate between January 2017 and December 2023.This study compared the clinical efficacy of different fixation methods for fracture sites (percutaneous Kirschner wire fixation or high-strength suture Nice knot fixation) and explored the feasibility and advantages of assisting high-strength suture Nice knot fixation of fracture sites based on coracoclavicular elastic fixation. The report is as follows.

Inclusion criteria

1.Fresh closed distal clavicle fracture combined with coracoclavicular ligament injury or avulsion fracture of the coracoclavicular ligament insertio; 2. The fracture line is an oblique or butterfly-shaped fragment in the fracture area; 3. Normal shoulder joint function before injury.

Exclusion criteria

1.Old distal clavicle fracture; 2. Fracture end morphology is transverse type, unable to be fixed by wire tying; 3. With ipsilateral mid-clavicular or proximal fracture, scapular fracture, coronoid process fracture; 4. Follow-up time is less than 1 year.

Patients

From January 2017 to December 2023, a total of 43 patients met the selection criteria and were included in this study. These patients were categorized based on the fracture site fixation method into two groups: the high-strength suture Nice knot fixation group (experimental group, n = 23) and the acromioclavicular Kirschner wire fixation group (control group, n = 20).

The experimental group: The patients consisted of 7 males and 16 females with an average age of 47.08 ± 12.89 (17–72) years, an average BMI of 25.19 ± 3.80 (17.43–31.34) Kg/m2, and the average length of hospital stay of 7.69 ± 1.67(5–12) days. There were 10 cases on the left side and 13 cases on the right side. The causes of injury included 8 traffic accidents, 13 falls, and 2 sports injuries. The fractures were classified according to Craig's classification with 14 cases of type ⅡB and 9 cases of type V. There were 2 cases of rib fractures.

The control group: The patients consisted of 5 males and 15 females with an average age of 45.8 ± 14.52 (19–72) years, an average BMI of 24.49 ± 3.50 (18.42–30.23) Kg/m2, and the average length of hospital stay of 7.55 ± 1.64(5–13) days. There were 8 cases on the left side and 12 cases on the right side. The causes of injury included 9 traffic accidents, and 11 falls. The fractures were classified according to Craig's classification, with 12 cases of type ⅡB and 8 cases of type V.

Pre-operation, both groups of patients underwent bilateral clavicular X-ray imaging and CT three-dimensional reconstruction of the affected shoulder. There were no significant differences in age, gender, cause of injury, Craig classification, comorbidities, length of stay, preoperative visual analog scale (VAS), American Shoulder and Elbow Surgeons (ASES) Score and Constant-Murley scores between the two groups before the operation (Tables 1–5).

Operation

Upon administering general anesthesia, the patient is positioned in a beach chair with their upper torso elevated between 30° and 50°. The affected shoulder is cushioned, the head and neck are gently extended backward, and turned towards the unaffected side. A transverse incision of 4–5 cm is made along the clavicle's long axis above the fracture site. This allows for layer-by-layer dissection of the skin and subcutaneous tissues to expose the fracture site, while also clearing any hematoma and soft tissue in the vicinity. Furthermore, a second incision of 2–3 cm is made on the coracoid process's surface. Blunt separation of the muscle tissue reveals the base of the coracoid process. For fracture reduction under direct vision, the control group uses two 2.0 mm K-wires to fix the fracture site percutaneously from the acromion; the experimental group uses non-absorbable sutures to tie a Nice knot to the fracture site for pre-reduction (note that the bone fragments torn off the insertion points of the trapezius or pyramidal ligaments should be tied to the shaft), and temporary fixation with K-wires can be added depending on the stability of the fracture. With the assistance of the shoulder-lock joint guide (Arthrex, USA), a 1.5 mm K-wire is used as a guide pin to establish a bone tunnel from the clavicle to the base of the coracoid process. A 3.2 mm hollow drill is used to drill through the bone tunnel along the guide pin direction. A self-developed guide (Fig. 3. patent ID ZL 2022 2 2614319.6) is used to introduce a traction wire from the clavicle through the bone tunnel to the coracoid process. The Endobutton (Arthrex, USA) with high-strength sutures is introduced from the bone tunnel on the clavicular. The Endobutton plate is placed at the base of the coracoid process, and another Endobutton plate is placed on the clavicle. Tighten the knot, confirm the satisfactory reduction of the fracture, and tie it up. The research group can tighten the Nice knot tied at the fracture end, and complete the final fixation with 3–5 single knots. The control group retains the Kirschner wire. After confirming the accurate reduction of the fracture and the good position of the plate with C-arm X-ray machine, the incision is closed with layered sutures.

Postoperative Treatment

Postoperatively, antibiotics were administered routinely for either one or two days. Within the first week following surgery, the affected shoulder joint was immobilized while the remaining joints of the limb could be exercised through flexion and extension movements. After a week, pendulum exercises for the shoulder joint were initiated. For the experimental group, activities involving shoulder joint elevation commenced four weeks

post-surgery. In contrast, for the control group, these activities were permitted only after the removal of Kirschner wires six weeks post-surgery.

Efficacy Assessments

Postoperative X-ray examinations were conducted to evaluate fracture healing. Potential complications, including infection, coronoid process fracture, displacement of the Kirschner wire, and local skin irritation, were documented. The distance between the affected and healthy sides of the coronoid process was measured on the X-ray images. The rate of increase in this distance was determined using the following formula: (value of the affected side – value of the healthy side) / value of the healthy side × 100%. Preoperatively, as well as at 1 month and 3 months post-operation, and at the final follow-up, the Visual Analog Scale (VAS), American Shoulder and Elbow Surgeons (ASES) Score, and Constant-Murley scores were assessed.

Statistical Analysis

The measurement data were in normal distribution and expressed as mean ± standard deviation. Independent sample T-tests were used for comparison between the two groups, and repeated measures analysis of variance was used for comparison of VAS, ASES, and Constant-Murley scores between the two groups. If the spherical test was not met, the Greenhouse-Geisser method was used for correction. The comparison between different time points in the same group was performed using Bonferroni method, and the comparison between different groups at the same time point was performed using multi-factor analysis of variance. The Fisher exact probability method was used for comparison between groups of count data. A value of P < 0.05 was considered statistically significant.

Both patient groups successfully underwent the operation without any severe complications, such as vascular and nerve injury, coracoid process fracture, etc. Postoperatively, one case in the control group experienced a minor pin tract infection, which improved after cleaning and dressing change. No complications such as skin necrosis or deep infection were observed. One case of Kirschner wire displacement occurred, which was removed by incision six weeks post-surgery. The experimental group did not experience any significant complications. Both groups were followed up for a period ranging from 12 to 33 months, with an average of (20.53 ± 5.16) months. The fracture healing time in the experimental group and the control group was (12.82 ± 1.12) weeks and (17.25 ± 1.71) weeks respectively, with a statistically significant difference (P < 0.05, Table 1). At the last follow-up, the increase rate of the coracoclavicular space in the experimental group and the control group was (9.25 ± 2.53) % and (8.12 ± 2.53) % respectively, with no statistically significant difference (P > 0.05, Table 2). The VAS, ASES, and Constant-Murley scores of both groups showed significant improvement one month after surgery compared to pre-operation, with statistically significant differences (P < 0.05, Tables 3,4and5). One month after surgery, the experimental group's ASES and Constant-Murley scores were significantly better than the control group, with statistically significant differences (P < 0.05, Tables 4and5). However, there was no statistically significant difference in ASES and Constant-Murley scores at three months post-operation and during the final follow-up (P > 0.05, Tables 4and5).

The coracoclavicular ligament plays a crucial role in maintaining the vertical stability of the distal clavicle. Fractures involving this structure, particularly those with associated ligament injuries, often exhibit poor stability and typically necessitate surgical intervention. Present fixation techniques primarily encompass rigid fixation via the fracture or acromion, flexible fixation through the coracoid process, and a combination of both methods. Rigid fixation predominantly involves the use of a clavicle hook plate and anatomical locking plate fixation. While the clavicle hook plate provides firm fixation, it restricts shoulder joint movement and is associated with numerous complications[13–15]. Conversely, the anatomical locking plate eliminates the need for trans-articular fixation and preserves the range of motion of the acromioclavicular joint. However, for extremely distal fractures, comminuted fractures, or osteoporotic fractures, its screws may not effectively stabilize the distal bone fragment. Therefore, rigid fixation without coracoclavicular ligament reconstruction carries a long-term risk of increasing the coracoclavicular distance[16].

Endobutton plates are prevalent flexible fixation techniques that indirectly stabilize and repair fractures by reconstructing the coracoclavicular ligament. Unlike traditional methods, they do not necessitate consideration of the size and shape of distal bone fragments, making them suitable for fracture types challenging to effectively secure with locking plates. While Endobutton plates efficiently maintain vertical fracture stability, they can potentially cause horizontal displacement, leading to a 'wipers' effect. This effect heightens the risk of nonunion and internal fixation failure[7, 11]. The Nice knot, a high-tension self-locking sliding knot, has shown promise in fracture reduction, fixation, and ligament repair[17]. However, its application in distal clavicle fracture fixation remains limited.

In this study, we examined 43 patients with distal clavicle fractures characterized by an oblique fracture line or a butterfly-shaped bone fragment at the fracture site. We fixed the fractures with an Endobutton plate and high-strength suture Nice knot, achieving good clinical results. Specifically, No. 5 Ethibond non-absorbable suture was employed for the fixation of the fracture ends via loop ligation. This suture is renowned for its superior strength and resistance to breakage, making it a preferred choice for tendon and ligament repairs as well as fracture fragment fixation. The Nice knot, a high-tension self-locking sliding knot, features a two-wire structure that tightens and slides under pressure, analogous to the function of a strapping belt. This design ensures stability, preventing the knot from slipping. Furthermore, the knot is not only easy to loosen but also user-friendly and can be reapplied multiple times. During surgical procedures, the knot's quick adjustment between loosening and tightening facilitates minor modifications and temporary fixation during fracture reduction[12, 14].

The experimental group in this study had a better average fracture healing time than the control group, and there were no cases of nonunion or delayed union. The average fracture healing time was much shorter than in earlier trials when clavicle fractures were fixed rigidly[17]. This is because the Nice knot gets tighter, reducing the fracture's displacement and separation distance while increasing the fracture site's contact area. Furthermore, it can have to do with the reduction and fixing of the fragments of the mall fracture, which serve as the ligaments' attachment points. Two patients in the control group in this trial had complications. Specifically, one patient developed a mild pin tract infection, characterized by local redness, swelling, and minor exudation, which caused shoulder pain and discomfort. Another patient suffered from Kirschner wire displacement and underwent surgical removal six weeks after the initial operation. In the control group, patients were required to wait for six weeks to have the Kirschner wires externally placed removed, leading to early postoperative limitations in shoulder joint function. However, following the removal of these wires, the patients' shoulder joint function demonstrated significant recovery and was effectively sustained at three months post-surgery and during the final follow-up. Conversely, patients in the experimental group opted for a superior treatment method involving the use of an Endobutton plate combined with high-strength suture Nice knot fixation. The primary advantage of this method is the rapid closure of the surgical wound, obviating the need for Kirschner wires to remain externally and eliminating the necessity for a secondary surgery to remove these wires. Consequently, patients in the experimental group were able to commence functional exercises early in the postoperative period. One month after the procedure, their shoulder joint function was significantly superior to that of the control group. As the follow-up period extended, these patients' shoulder joint function continued to improve and remained in a good state for an extended period. This treatment approach not only expedites patient recovery but also contributes to the long-term maintenance of optimal shoulder joint function.

During the tying of the Nice knot, attention should be paid to avoid early tightening to avoid loosening. It is recommended that the Nice knot be retightened after the final fixation of the Endobutton plate. This step can effectively ensure the stability of the Nice knot. When the ends of the sutures are tightened, if necessary, a needle holder can be used to gently push and compact the knot to make it more secure. When the sutures are under high tension, multiple square knots should be tied with both ends to achieve a firm final lock, which can not only improve surgical results but also effectively reduce the risk of knot loosening. The Nice knot uses a double-line structure, and guiding the folded line loop is an important step[18, 19]. The traditional device needs a guide to first draw out a single line, and then use this single line to fix and draw out the folded line loop, which is cumbersome and time-consuming. To simplify the operation, we designed a ring-structured wire loop guide[20].This innovative design allows for close adhesion to the clavicle and facilitates smooth circular guidance of the wire. The unique structure not only streamlines surgical procedures but also significantly boosts their efficiency. Crucially, this guide can accomplish the guidance of the folded line loop in a single step, thereby optimizing the surgical process considerably. This cutting-edge technology has been successfully implemented in our research to date.

Patients with distal clavicle fractures in this study showed a particular pattern of fracture line displacement: the distal end changes forwards and downwards, while the proximal fracture line tends to migrate backwards and upwards. The anterior and middle bundles of the deltoid muscle and the trapezius muscle's connection to the distal clavicle are the main causes of this pattern. A distal clavicle fracture is commonly caused by a direct, severe collision to the shoulder. The proximal clavicle fracture line is immediately pulled by the trapezius muscle, which extends from the back up to the front down, shifting it upward and backward. The distal fracture end is simultaneously pulled by the deltoid muscle, causing a displacement both forward and downward. It is important to recognize the unique anatomical relationship between the coracoid process and the distal clavicle. In the sagittal plane, the coracoid process precedes the distal clavicle, while in the coronal plane, it lies beneath it. This spatial orientation enables the Endobutton plate's bone tunnel to be oriented from front to back, paralleling the direction of fracture displacement. Such alignment confers a distinct advantage to the Endobutton plate in terms of reduction and fixation. It can align with the natural trajectory of fracture displacement, ensuring stable support and fixation, thereby facilitating expedited fracture healing and recovery. In essence, the Endobutton plate's alignment with the fracture displacement direction offers a distinctive benefit in the reduction and fixation of distal clavicle fractures.

In conclusion, Nice knots can be used as an effective supplement to Endobutton plates for oblique fractures or distal clavicle fractures with butterfly bone fragments. The combination of Nice knots and Endobutton plates can significantly improve the stability of the fracture, promote fracture healing, and allow patients to perform early functional rehabilitation. In addition, it can reduce the complications caused by percutaneous Kirschner wire fixation. However, this study is a retrospective case analysis without a prospective design and has limitations such as a small sample size and short follow-up time. Therefore, further large-scale randomized controlled studies with long-term follow-up are needed to confirm our results.

Table 1

Baseline characteristics () in both groups.
	Total (n = 43)	A(n = 23)	B(n = 20)	P
Age (years)	46.28 ± 13.69	47.08 ± 12.89	45.8 ± 14.52	0.76
Gender (female/male)	31/12	16/7	15/5	0.69
BMI(Kg/m2)	24.87 ± 3.64	25.19 ± 3.80	24.49 ± 3.50	0.53
LOS(length of stay)	7.69 ± 1.67	7.82 ± 1.72	7.55 ± 1.64	0.59
Bone healing time	14.88 ± 2.61	12.82 ± 1.12	17.25 ± 1.71	< 0.05
Drinking history	16(37%)	8(35%)	8(40%)	0.72
Smoking history	18(42%)	10(44%)	8(40%)	0.053
Hypertension	16(37%)	8(35%)	8(40%)	0.13
Diabetes mellitus	8(19%)	3(13%)	5(25%)	1.01
Craig's classification
ⅡB	26(60%)	14(60%)	12(60%)	0.95
V	17(40%)	9(40%)	8(40%)	0.95
A: the experimental group; B: the control group; LOS:length of stay in hospital

Table 2

Coracoclavicular space ()
Group	Pre-op.	1month	3months	LFU	p(pre-op.vs.1m)	p(1m vs. 3m)	p(3m vs. LFU)
A	62.76 ± 28.74	9.37 ± 3.46	9.66 ± 2.95	9.25 ± 2.53	< 0.05	0.77	0.62
B	68.36 ± 30.59	7.49 ± 3.41	8.23 ± 2.60	8.10 ± 2.53	< 0.05	0.46	0.88
p(A vs. B)	0.54	0.08	0.10	0.16
A: the experimental group; B: the control group;1month: 1month post-operation; 3 months: 3 months post-operation; LFU:last follow-up

Table 3

Visual analogue scale (VAS; )
Group	Pre-op.	1month	3months	LFU	p(pre-op.vs.1m)	p(1m vs. 3m)	p(3m vs. LFU)
A	7.47 ± 1.01	2.52 ± 0.65	2.26 ± 0.94	1.83 ± 0.86	< 0.05	0.29	0.12
B	7.55 ± 1.02	4.05 ± 0.80	2.25 ± 1.09	1.80 ± 0.67	< 0.05	< 0.05	0.13
p(A vs. B)	0.82	< 0.05	0.97	0.91
A: the experimental group; B: the control group;1month: 1month post-operation; 3 months: 3 months post-operation; LFU:last follow-up

Table 4

Constant-Murley Score ()
Group	Pre-op.	1month	3months	LFU	p(pre-op.vs.1m)	p(1m vs. 3m)	p(3m vs. LFU)
A	43.86 ± 8.87	88.95 ± 1.82	90.52 ± 3.89	91.26 ± 3.21	< 0.05	0.09	0.48
B	40.95 ± 9.31	67.95 ± 5.95	90.65 ± 3.64	91.15 ± 2.70	< 0.05	< 0.05	0.59
p(A vs. B)	0.29	< 0.05	0.91	0.90
A: the experimental group; B: the control group; 1month:1month post-operation; 3 months: 3 months post-operation; LFU:last follow-up

Table 5

American Shoulder and Elbow Surgeons (ASES) Score ()
Group	Pre-op.	1month	3months	LFU	p(pre-op.vs.1m)	p(1m vs. 3m)	p(3m vs. LFU)
A	41.45 ± 7.81	88.54 ± 1.97	89.86 ± 3.42	91.22 ± 2.73	< 0.05	0.13	0.14
B	41.42 ± 9.78	67.63 ± 6.05	91.05 ± 3.06	90.78 ± 2.95	< 0.05	< 0.05	0.91
p(A vs. B)	0.99	< 0.05	0.26	0.71
A: the experimental group; B: the control group; 1month:1month post-operation; 3 months: 3 months post-operation; LFU:last follow-up

Acknowledgments

I want to thank everyone who has supported me while I've been writing this paper. I sincerely thank Haiyang Yu and my supervisor, Professor Jishi Jiang, for their assistance. Throughout the composition of this report, I really appreciate their expert guidance, support, and patience.

Statement of study participation

Consent was obtained from the patients or their guardians in Chinese.

Authors’contributions

Liu bin is the first author and major contributor in writing manuscript and interpreting the data. Shi lei is the co-first author. Ma huifang performed the collection and follow-up investigation. Jiang jishi and Yu haiyang contributed to the procedure and design of the study and critically revised the manuscript and contributed the intellectual content. All authors read and approved the integrity and accuracy of the final manuscript.

Funding

This research was conducted with the financial support of the Fuyang Health and Wellness Scientific Research Project (grant number FY2023-114 and FY2021-017).

Availability of data and materials

According to reasonable requirements, the corresponding authors will provide original data to support the conclusions of this paper.

Ethics approval and consent to participate

The study was conducted according to the guidelines of the Declaration of Helsinki, and approved by the Institutional Review Board of Fuyang people’s Hospital. Written informed consent is obtained from legal guardian of participants.

Consent for publication

Not applicable.

Competing interests

The authors declare no competing interests.

Author details

¹Department of Orthopaedics, Fuyang People’s Hospital Affiliated to Anhui Medical University, Anhui 236000, China.

²Fuyang People's Hospital affiliated to Bengbu Medical University, Anhui 236000, China

³Taihe County Second People's Hospital，Anhui 236000, China

⁴Clinical Research Center for Spinal Deformity of Anhui Province, Anhui 236000, China, China

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No competing interests reported.

Analysis of the efficacy of Endobutton plate combined with high-strength suture Nice knot fixation in the treatment of distal clavicle fractures with coracoclavicular ligament injuries

Status:

Version 1

Abstract

Figures

Introduction

Materials and methods

Operation

Postoperative Treatment

Efficacy Assessments

Statistical Analysis

Results

Discusssion

Declarations

References

Additional Declarations

Status:

Version 1