Novel Triangular Anchor Reduction Forceps versus Towel Forceps for Long Oblique or Spiral Distal Tibial Fractures: A Comparative Study

doi:10.21203/rs.3.rs-3194442/v1

Objective: To compare the efficacy of triangular anchor repositioning forceps and scarf forceps in the treatment of long oblique or spiral distal tibial fractures with intramedullary nailing.

Methods: Finally, 58 patients were included. According to the intraoperative repositioning method, they were divided into the scarf clamp repositioning group (n=26) and the triangular anchor repositioning group (n=32). The operative time, a number of intraoperative fluoroscopies, intraoperative bleeding, quality of postoperative fracture reduction, length of hospital stay, fracture healing time, American orthopedic foot and ankle society (AOFAS) score, efficacy and complications at the last follow-up were compared between the two groups.

Results: All patients participated in more than 1 year of follow-up. ①There were no significant differences in the composition ratios of age, sex, underlying disease, and mechanism of injury between the two groups; ②The operating time and intraoperative fluoroscopy number of patients in the triangular anchor reduction group were significantly lower than those in the scarf clamp reduction group (P<0.05), while the quality of fracture reduction was higher than that in the scarf clamp reduction group (P<0.05), and the differences in the remaining perioperative indexes were not significant; ③Patients in the triangular anchor reduction group had shorter postoperative fracture healing time and better ankle function than those in the scarf clamp reduction group (P<0.05); ④Patients in the two groups had various There was no significant difference in the incidence of various complications between the two groups, but the overall complication rate was significantly lower in the triangular anchor reduction group (P<0.05).

Conclusion: The use of triangular anchor repositioning forceps can improve the quality of fracture repositioning, shorten fracture healing time, reduce the occurrence of complications, reduce the operative time and the number of intraoperative fluoroscopies, and no significant increase in local infection was observed, which is an effective and reliable repositioning method.

Distal tibial fracture

Resetting forceps

Intramedullary nail

Distal tibial fractures account for approximately 10% of all tibial fractures^{[1, 2]} and are a relatively common type of injury in clinical practice. Due to the proximity of the distal tibia to the ankle joint, difficulties in fracture reduction and fixation, local soft tissue coverage, and poor blood supply have become challenging clinical problems^[3]. The occurrence of ankle osteoarthritis due to poor repositioning is predictable^[4]; therefore, the closer the anatomic repositioning, the fewer adverse effects on the ankle^[5]. Currently, there is a growing consensus on the treatment of tibial fractures with intramedullary nailing, which stems from the biomechanical advantages of its central fixation and the protection of local blood flow due to minimally invasive implantation. The prerequisite for achieving these advantages is a satisfactory minimally invasive reduction of the fracture before implantation of the intramedullary nail and reliable maintenance of the fracture reduction.

There are various ways to maintain fracture repositioning, for example, the use of a repellent band for fracture repositioning and the maintenance of repositioning, and also reported in the literature^[6] the use of a scarf clamp for repositioning and studied the safety during scarf clamp repositioning, which confirmed that scarf clamp repositioning can avoid vascular nerve damage and is a safe repositioning method.Forman JM et al^[7] reported a percutaneous clamp technique for repositioning distal tibial fractures with intramedullary nailing treatment, and they concluded that until a superior technique is available, percutaneous scarf clamp reduction is a more desirable means of reduction technique. It has also been reported in the literature that the fracture was first temporarily repositioned and temporarily fixed with external fixation pins avoiding the intramedullary nail implantation channel, and satisfactory results were also achieved^[8].

However, the above reset methods have some shortcomings. The expelling belt is not suitable for obese patients, the temporary reduction of the external fixator will increase the cost of patients, and the compression injury of local skin caused by traditional towel clamp reduction can not be ignored, in addition, when reaming or changing position due to fluoroscopy, towel clamp is easy to cause the loss of reduction. In this study, we used our special tibial resetting forceps, the triangular anchor (Fig. 1), which can effectively avoid skin compression injury and does not cause clamping failure, and can satisfactorily achieve fracture reduction and maintenance of the reduction.

Patient and methods

Retrospective analysis of 58 patients with displaced long oblique or spiral distal tibial fractures admitted to our institution between January 2020 and March 2022, all treated with intramedullary nail fixation (TriGen META; YZB/USA 0391–2012). Patients who met the following criteria were included: (1) distal tibial fracture; (2) spiral or long oblique fracture; (3) fresh fracture; (4) closed fracture; (5) age > 16 years; and (6) no medullary deformity or medullary stenosis. Patients who met the following criteria were excluded: (1) old fractures; (2) open fractures; (3) age less than 16 years; (4) transverse tibial fractures; (5) comminuted tibial fractures; and (6) those with medullary cavity deformity or stenosis. Finally, a total of 58 patients were included in our study for analysis. The patients were divided into two groups according to the method of repositioning: the scarf clamp repositioning group, with 26 patients, 15 males, and 11 females, aged 42–78 years; and the triangular anchor repositioning group, with 32 patients, 18 males and 14 females, aged 37–75 years. Preoperative X-ray frontal and lateral tibiofibular radiographs, as well as CT plain + 3D reconstruction images of all patients, were perfected, and multidisciplinary consultations were held to assess the underlying disease, and prompt surgical treatment was performed after the general status was stable and the skin of the affected limb was decongested. Both groups of patients were treated with intramedullary nail fixation by the same team.

Operative technique

The patient is placed in a flat position, the area is disinfected and toweled, the fracture line is located, and a triangular anchor repositioning forceps clamp point is taken at the distal and proximal ends of the fracture, generally 1–2 cm from the fracture line, then the repositioning forceps are positioned on the skin of the lower leg, the medial clamp point is near the posterior edge of the tibia, the lateral is located on the middle and lower two-thirds of the lateral tibial surface, a 5mm incision is made as marked, and a 2.5mm diameter kerf pin is drilled for the ball end of the repositioning forceps. The ball head of the restoration forceps was drilled with a 2.5 mm diameter kerf pin for clamping. The tip of the ball end of the triangular anchor resetting forceps is placed against the pre-drilled hole, the assistant traction rotates the lower limb, gradually tightens the resetting forceps, fluoroscopically verifies the fracture repositioning, and after satisfaction with the skin and subcutaneous tissues of the opening are routinely cut, the needle entry site is revealed, the positioning guide is inserted in the correct position, the medullary cavity is drilled, the long ball end guide needle is placed with the assistance of the golden finger, the position is fluoroscopically verified, the main nail of the intramedullary nail is placed, and fluoroscopy shows The fluoroscopy verified the fracture repositioning and internal fixation position. The gauze instruments were counted correctly, the wound was closed layer by layer, and postoperative symptomatic treatment such as anti-inflammation and rehydration was given. The surgical approach was the same in both groups, with the difference being that in the towel clamp reduction group, a towel clamp was used instead of a triangular anchor reduction clamp to maintain the fracture position during intraoperative fracture reduction. Intraoperative pictures are shown in Fig. 2.

Post-operative management and follow-up

Postoperatively, cephalosporins of the 1st and 2nd generation were routinely given intravenously to prevent infection for no more than 24 hours, with an appropriate extension to 48 hours for patients with wound erythema or combined diabetes. 4000 U of low molecular heparin sodium was routinely administered subcutaneously once daily after 10 hours. Immediately after surgery, a full-length frontal and lateral tibiofibular X-ray was taken to assess the fracture reduction. Functional exercises of the knee and ankle joints were started on the second day after surgery and about one week after surgery, the patients were discharged from crutches to walk normally, and moderate functional exercises were performed according to the review after discharge. All patients underwent routine full-length frontal and lateral tibiofibular radiographs at 1, 2, 3 and 6 months after surgery, followed by annual review. The general condition, operative time, number of fluoroscopies, quality of fracture reduction, fracture healing time, AOFAS score at the last follow-up, and complications were recorded for both groups. Fracture healing was defined as the union of at least three cortices on follow-up radiographs, and healing time longer than six months was defined as delayed healing^[9]. Quality of fracture repositioning was defined as (1) an angle of < 10° at the fracture end on measured orthopantomography, (2) displacement between major fracture fragments < 5 mm, and (3) gap between major fracture fragments < 5 mm. good repositioning met all three criteria, acceptable repositioning met two criteria, and poor repositioning met one or all of the noncompliance criteria^[10].

Statistical analysis

SPSS 26.0 software was used for statistical analysis.The continuous data were expressed as mean ± standard deviation (SD), and the differences between groups were evaluated by independent Student’s t-test. The classified data are represented by numbers and percentages (%), and the differences between groups are evaluated by chi-square test. When P < 0.05, there was statistical difference between the two groups.

Patient and baseline information

In our study, 58 patients with displaced long oblique or spiral distal tibial fractures completed the final follow-up. Of these, 26 patients, including 15 men and 11 women (mean age:56.81 ± 6.48 years, range:42–75 years), were treated with scarf clamp repositioning and 32 patients, including 18 men and 14 women (mean age:55.88 ± 5.70 years, range:40–72 years), were treated with triangular anchor repositioning clamp repositioning. The mechanism of injury was mainly traffic injuries, followed by falls. No significant group differences were observed between the two groups in terms of baseline information. Detailed information is shown in Table 1.

Table 1

Comparison of baseline data of patients of two groups
Project	Scarf clamp repositioning group (n = 26)	Triangular anchor repositioning group (n = 32)	t /x²	P
Age (years)	56.81 ± 6.48	55.88 ± 5.70	t = 0.583	0.779
Gender [n (%)]			x² = 0.012	0.912
Male	15(58%)	18(56%)
Female	11(42%)	14(44%)
Underlying diseases [n (%)]
High blood pressure	4(15%)	6(19%)	x² = 0.114	0.736
Diabetes	1(4%)	1(3%)	x² = 0.022	0.881
Coronary artery disease	1(4%)	2(6%)	x² = 0.169	0.681
Injury mechanism [n (%)]			x² = 0.275	0.600
Fall	5(19%)	8(25%)
Traffic injury	21(81%)	24(75%)

Comparison of perioperative indicators

There was a significant difference (P < 0.05) in the operative time (16.42 ± 3.59 days in the towel clamp group versus 15.41 ± 2.63 days in the triangular anchor group; P = 0.004) and the number of intraoperative fluoroscopies (19.19 ± 2.56 days in the towel clamp group versus 16.00 ± 1.67 days in the triangular anchor group; P = 0.002) between the two groups, which may be because that the triangular anchor resetting forceps can the fracture ends can be firmly fixed at the time of resetting to avoid temporary fixation failure leading to fracture displacement, thus reducing the number of intraoperative fluoroscopic views and saving operative time. It is worth noting that the use of triangular anchor repositioning forceps required three additional small incisions compared to towel forceps, but there was no significant difference in intraoperative blood loss between the two groups (91.85 ± 12.37 ml in the towel forceps group versus 100.31 ± 16.32 days in the triangular anchor group; P = 0.288). The quality of fracture reduction in the towel clamp group (difference: 15%) was significantly worse than that in the triangular anchor reduction group (difference: 0%) (P < 0.05), which may be analyzed because the triangular anchor uses its own three-ball head design to form a stable triangular structure, thus not shifting the clamping site due to changing limb position and vibration during medullary expansion, resulting in a better quality of postoperative reduction. In addition, there was no significant difference in the length of hospital stay between the two groups. No perioperative mortality occurred in the patients. Detailed information is shown in Table 2.

Table 2

Comparison of perioperative data between the two groups
Project	Scarf clamp repositioning group (n = 26)	Triangular anchor repositioning group (n = 32)	t /x2	P
Length of stay (d)	16.42 ± 3.59	15.41 ± 2.63	t = 1.245	0.155
Operation time (min)	97.00 ± 14.39	83.34 ± 8.78	t = 4.445	0.004
Perspective times	19.19 ± 2.56	16.00 ± 1.67	t = 5.722	0.002
Intraoperative blood loss (ml)	91.85 ± 12.37	100.31 ± 16.32	t=-2.183	0.288
Fracture reduction quality [n (%)]
Excellent	13(50%)	25(78%)
Acceptable	9(35%)	7(22%)
Poor	4(15%)	0(0%)	x² = 5.288	0.021

"-" means using Fisher's exact test.

Postoperative follow-up analysis

All patients were successfully discharged from the hospital and both groups were followed up for more than 1 year. There was no significant difference in the VAS score at the final follow-up (2.35 ± 0.85 in the towel clamp group versus 2.44 ± 1.05 in the triangular anchor group; P = 0.242). Time to fracture healing (> 6 months: 27% in the towel clamp group. 3% for the triangular anchor group, P = 0.009) and AOFAS score at the last follow-up (poor: 11% for the towel clamp group and 0% for the triangular anchor group, P = 0.048) were significantly different. Detailed information is shown in Table 3.

Table 3

Comparison of postoperative follow-up data between the two groups
Project	Scarf clamp repositioning group (n = 26)	Triangular anchor repositioning group (n = 32)	t /x²	P
Fracture healing time [n (%)]			x² = 6.832	0.009
≤ 6 months	19(73%)	31(97%)
＞6 months	7(27%)	1(3%)
AOFAS score [n(%)]
Excellent	8(31%)	13(41%)
Good	9(35%)	16(50%)
Acceptable	6(23%)	3(9%)
Poor	3(11%)	0(0%)	x² = 3.894	0.048
VAS score	2.35 ± 0.85	2.44 ± 1.05	t=-0.36	0.242

Complications

Two patients (8%) in the scarf clamp repositioning group developed a shortened deformity and received rehabilitation. Three patients (11%) in the scarf clamp repositioning group and one patient (3%) in the triangular anchor repositioning group developed ankle osteoarthritis and received symptomatic treatment such as weight reduction and anti-inflammatory treatment. One patient (4%) in the scarf clamp repositioning group and one patient (3%) in the triangular anchor repositioning group developed superficial wound infection, which was treated with an alcohol dressing and appropriate antibiotics, and the wound healed well. One patient (4%) in the scarf clamp reduction group developed bone nonunion, and the fracture healed after a second surgery. All symptoms of complications improved or disappeared after conventional treatment. In addition, there was a significant difference in the overall complication rate between the two groups (37% in the scarf clamp group versus 6% in the triangular anchor group; P = 0.031), but there was no significant group difference in each complication (P > 0.05). Detailed information is shown in Table 4.

Table 4

Comparison of postoperative complications between the two groups[n(%)]
	Scarf clamp repositioning group (n = 26)	Triangular anchor repositioning group (n = 32)	x²	P
Shortening deformity	2(8%)	0(0%)	2.549	0.110
Ankle arthritis	3(11%)	1(3%)	1.581	0.209
Incision infection	1(4%)	1(3%)	0.022	0.881
Bone nonunion	1(4%)	0(0%)	1.252	0.263
Total complication	7(37%)	2(6%)	4.677	0.031

The current study involved 58 patients with displaced long oblique or spiral distal tibial fractures treated with intramedullary nailing who showed a significant increase in the quality of fracture healing and a significant decrease in fracture healing time when using the triangular anchor repositioning forceps technique compared with the conventional scarf clamp repositioning technique. In addition, the triangular anchor repositioning forceps technique minimized the number of intraoperative fluoroscopies and operative time and improved postoperative ankle function. This new resetting forceps has shown significant results in the treatment of long oblique or spiral distal tibial fractures.Typical cases are shown in Fig. 3.

The percutaneous scarf clamp technique for resetting distal tibial fractures with intramedullary nailing has been described by^[7], whose study showed that 100% of the 27 patients included (OTA types 42-A, 43-A, and 43-B) achieved acceptable alignment, i.e., < 5° displacement in any plane, and concluded that percutaneous scarf clamp resetting is an effective and better technique than the commonly used techniques. However, in our study, four cases of malrotation were found after using scarf clamp reduction, which had a higher rate of malrotation than the triangular anchor reduction technique (P < 0.05). This may be due to the different types of patients included and the different criteria for assessing the quality of fracture reduction. However, it still proved that the percutaneous scarf clamp reduction technique does not perform a perfect fracture reduction in the face of long oblique or spiral distal tibial fractures. We could observe no significant difference in intraoperative blood loss between the two groups (P > 0.05), but intraoperative blood loss was lower in the scarf clamp group (91.85 ± 12.37 ml) than in the triangular anchor group (100.31 ± 16.32 ml). This may be due to the three-ball head design of the triangular anchor resetting forceps, which required three additional incisions, even though the incisions were small, and still caused additional damage to the soft tissues of the skin. However, the ball-tip connecting rod of the triangular anchor has a rounded design with a diameter larger than the calf diameter, which in turn prevents the formation of pressure damage to the soft tissues of the skin during the resetting process.

A study by Rolando M et al^[4] found that the higher the degree of malalignment of the ankle joint, the higher the rate of joint morbidity. They concluded that tibial fractures should be repositioned as close to the anatomy as possible to reduce the incidence of early degenerative arthritis. In our follow-up, we found that AOFAS scores were worse in the scarf clamp reduction group (P < 0.05) and the incidence of ankle arthritis was greater (11%) than in the triangular anchor reduction group (3%). These are in line with the findings of RolandoM et al. and further demonstrate that the triangular anchor resurfacing clamp has a superior resurfacing effect. Whereas a previous report^[11] compared the efficacy of retractor and manipulative traction repositioning techniques combined with minimally invasive plate osteotomy (MIPO) for distal tibial fractures, they suggested that the difficulty in MIPO treatment is to achieve satisfactory fracture repositioning and to maintain this repositioning by indirect repositioning techniques. Interestingly, the same difficulty was found in our study. However, the ingenious design of the triangular anchor repositioning forceps solved this problem. Its ball tip is designed to match exactly the 2.5 mm diameter kerf pin borehole, so that the ball tip can be perfectly placed in the hole as well as the design of three ball tips can take advantage of the stability principle of the triangle, thus achieving firm fixation without displacement of the clamping site, temporary fixation failure and fracture displacement due to changing limb position and vibration during medullary expansion.

In terms of complications, it has been demonstrated that intramedullary nailing for distal tibial fractures has a high incidence of postoperative complications, including instability, malunion, and bone nonunion^{[12, 13]}. In our study, this phenomenon could be observed. The overall complication rate after repositioning with a scarf clamp was 37%, while the overall complication rate after triangular anchor repositioning was 7%, with a significant difference between the two groups (P < 0.05). However, interestingly, the various complications were not significantly different between the two groups (P > 0.05), which was also reported in a study by Lu et al^[14]. Therefore, the use of triangular anchor repositioning forceps can reduce the incidence of complications after intramedullary nailing for long oblique or spiral distal tibial fractures and greatly improve the outcome of intramedullary nailing.

There are several limitations to this study. First, the triangular anchor resetting forceps had limited value in resetting transverse tibial fractures and limited effectiveness in resetting comminuted fractures due to lack of fulcrum, limiting its applicability; second, the long oblique and spiral distal tibial fractures were not further subdivided for comparative study during the study, which will be refined in our future clinical work.

In conclusion, the use of the triangular anchor repositioning forceps in the treatment of long oblique or spiral distal tibial fractures with intramedullary nailing can improve the quality of fracture repositioning, shorten fracture healing time, reduce the occurrence of complications, reduce the operative time and the number of intraoperative fluoroscopies, and show no significant increase in local infection, which is an effective and alternative new internal fixation repositioning modality. We suggest that in the treatment of long oblique or spiral distal tibial fractures with significant displacement, the triangular anchor repositioning forceps can be utilized to maintain intraoperative repositioning, improve the quality of postoperative fracture repositioning, and bring better outcomes to patients.

Acknowledgements

Not applicable.

Author contributions

Xu X designed the study and critically revised the manuscript. Li T wrote the manuscript. Li T and Wu Z collected the data. Wang J andTang Y introduced the surgical strategy and Xu X helped to modify the procedure. All authors reviewed the manuscript.

Funding

This research is supported by the 2021 Anhui Province Key Research and Development Program Project (9101193201).

Data Availability

The data and materials can be obtained by contacting the corresponding author via email.

Competing interests

The authors declare no competing interests.

Ethics approval and consent to participate

This study received approval from the ethical committee of the Second Affiliated Hospital of Anhui Medical University (Approval No.SL-YX2022-137). All experiments were conducted following pertinent guidelines and regulations, including adherence to the Declaration of Helsinki. Written informed consent was obtained from all patients participating in the study.

Consent for publication

Not applicable.

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No competing interests reported.

Novel Triangular Anchor Reduction Forceps versus Towel Forceps for Long Oblique or Spiral Distal Tibial Fractures: A Comparative Study

Status:

Version 1

Abstract

Figures

Background

Methods

Patient and methods

Operative technique

Statistical analysis

Results

Patient and baseline information

Comparison of perioperative indicators

Postoperative follow-up analysis

Complications

Discussion

Conclusion

Declarations

References

Additional Declarations

Status:

Version 1