The efficacy and safety of small incision open reduction and intramedullary nail fixation surgery in the treatment of simple tibial shaft fracture

doi:10.21203/rs.3.rs-919258/v1

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The efficacy and safety of small incision open reduction and intramedullary nail fixation surgery in the treatment of simple tibial shaft fracture

https://doi.org/10.21203/rs.3.rs-919258/v1

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Objective: To explore the clinical efficacy and safety of small incision open reduction and intramedullary nail internal fixation surgery in the treatment of simple tibial shaft fracture compared to the closed reduction surgery.

Methods: A total of fifty patients with simple tibial shaft fractures admitted to our hospital were randomly and equally assigned into the observation group and the control group. Patients in the observation group received small incision open reduction surgery with intramedullary nail while patients in the control group received the closed reduction surgery. The clinical efficacy, prognosis as well as safety profile were compared between the two groups.

Results: Our data indicated that the average bleeding volume of patients in the observation group was increased while the operation time was decreased compared to the control group. No significant difference of postoperative complications, fracture healing time, and Johner-Wruhs scores was identified between the two groups.

Conclusion: The small incision open reduction surgery can significantly shorten the operation time while achieved a similar clinical efficacy compared to the closed reduction surgery in simple tibial shaft fracture.

Orthopedic Surgery

Orthopedics

Closed reduction

small incision open reduction

simple tibial shaft fracture

intramedullary nail

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Tibial fracture is a common type of fracture with an incidence of 16.9/100,000/year and accounts for approximately 13.7% of all fractures. Simple tibial shaft fractures (type A, B and C1, C2 in the AO classification) accounted for 34% of all tibial fractures[1, 2]. The simple tibial shaft fracture mainly presents as calf pain, swelling, deformity and so on. In recent years, many studies [3-8]have shown that closed reduction or open reduction with intramedullary nail has a better efficacy compared to the conventional treatment method and can effectively shorten the fracture healing time as well as reduce the incidence of postoperative complications. However, these studies were mostly retrospective and included not only simple fractures, but also comminuted fractures, and Gustilo A, B, and C fractures. To further explore the clinical efficacy of closed or limited open reduction surgery and internal fixation with intramedullary nails for the treatment of simple tibial shaft fractures, we conducted a prospective study including 50 cases patients. The research results were reported as follows:

1.1 Inclusion and exclusion criteria
Inclusion criteria: 1. Patients with simple tibial shaft fractures (Type A, B and C1, C2 according to the AO classification); 2. No open wound discovered around the fracture area; 3. No significant ipsilateral displacement that affecting reduction of ankle and knee fractures; 4. Normal cardiopulmonary function and stable hemodynamics; 5. No obvious osteoporosis;

Exclusion criteria: 1. Patients with complex, comminuted or multi-segment tibial shaft fracture; 2. Complicated with open injury involved the operation area; 3. Ipsilateral knee and ankle joint injury and/or fracture displacement that affecting the operation method; 4. Patients with refractory severe hypertension (>180/110mmHg); patients with refractory blood sugar> 13.9mmol/L; patients with severe cardiopulmonary, liver and kidney insufficiency; patients with systemic diseases and immunodeficiency; patients with severe malnutrition or conditions unsuitable for surgery; patients with infection, bacteremia, and/or sepsis; other conditions which might render the patient intolerable for surgery; 5. patients with severe osteoporosis that affect the stability of intramedullary nail fixation; 6. patients who refused to participate the study; 7. Patients with severe mental illness or other cognitive disorders that might seriously affect postoperative functional evaluation; 8. Patients with pathological fractures;

1.2 Surgical procedures
All patients were operated on by the same experienced orthopedic and trauma surgeon. To prevent biases, all records were examined by two independent orthopedic surgeons who had no relation with the patient‟s treatment.

All patients were in the supine position and received spinal anesthesia. All intramedullary nails were non-reamed locking tibial interlocking intramedullary nail system (CanTN) provided by CANWELL.

In this study, all surgeries used infrapatellar approach. Some other studies[9, 10] might argue that the suprapatellar approach was a better approach but this study was not powered to examine the difference between different approaches.

The observation group (small incision reduction intramedullary nail fixation method): Centered by the end of the fracture, a small incision, usually 3 cm, was made with limited stripping of the periosteum before reducing the fracture end and temporarily fixing with bone clamp. Another longitudinal incision about 5cm above the tibial tubercle was carried out and the patellar ligament was split longitudinally to expose the "slope" of the tibial plateau. The medial side of the intercondylar crest of the tibial plateau was used as the entry point, and the platform was opened to the medullary cavity with a triangular pyramidal. Then the guide pin was inserted into the medullary cavity, followed by the selected intramedullary nail along the guide pin under C-arm fluoroscopy. After inserting the intramedullary nail, the temporarily fixed bone clamp was removed and the remote locking nail was installed followed by 2 suitable locking nails through the sleeve of the remote sight. Draw with the intramedullary nail backwards, and appropriately pressurize the fracture area. Insert 2 or 3 proximal locking nails through the sleeve of the proximal sight and remove the bracket and screw in the tail cap before the completion of the surgery.

The control group (closed reduction intramedullary nail fixation ): The closed reduction operation was used to reduce the fracture end, and the intramedullary nail was inserted after C-arm fluoroscopy identified the ideal position of the fracture end. The rest of the operation was carried out the same as the observation group.

1.3 Postoperative management

One day after the operation, antibiotics was given to prevent infection as well as other supportive treatments to relieve pain and other symptoms. On the second day after the operation, active flexion and extension exercises of knee joint, ankle joint and toe were performed in bed. After clinical and X-ray examinations showing clinical healing of the fracture, crutches can be gradually abandoned. Series of imaging were regularly taken to monitor the fracture healing process.

1.4 Observation indicators:

The operation time, blood loss and intraoperative complications (such as whether there is blood vessel or nerve damage) were documented. Patient was followed up at 2 weeks, 1 month, 3month and 6 months after the operation by either on-site or telephone follow-up. At two weeks and one month after the operation, the local incision healing of the patients was evaluated as well as the presence or absence of postoperative incision infection. The fracture healing and the function of the affected limb were observed at 1 month, 3month and 6 months after the operation (according to the Johner-Wruhs scoring standard[11] and was graded into four levels: excellent, good, moderate, and poor).

1.5 Statistical methods:
All data was processed by statistical software SPSS12.0. The comparison between groups was examined by t test and χ2 test. P<0.05 indicated that the difference was statistically significant.

1.6 Safety indicators:
The two surgical methods applied in the study were verified for safety and the surgical technology was mature. In the process of closed reduction of the fracture end, the posterior tibial blood vessels and nerves might be damaged when the bone clamp was applied, but the incidence was extremely low. In this experiment, 3 patients with vascular and nerve damage were selected for safety indicators. If the adverse event exceeded the predetermined index, the experiment would be immediately terminated.
This study complies with relevant ethical standards and was approved by the hospital ethics committee.

2.1 Study population
A total of 50 patients with simple tibial fracture diagnosed at our hospital from 2019 to 2020 were prospectively enrolled in this study. All patients signed informed consent forms and were randomly and equally divided into the observation group and the control group. In the observation group, there were 19 male patients and 6 female patients ranged from 27 to 63 years, with an average age of (43.28±2.62) years and consisting of 9 type A, 11 type B, and 5 type C fractures. In the control group, there were 17 male patients and 8 female patients ranged from 25 to 63 years old, with an average age of (43.88±2.32) years and consisting of 10 type A, 12 type B, and 3 type C fractures. No significant difference was observed in the baseline characteristics between two groups.
2.2 Operation time, blood loss and fracture healing time
In this group, the average operation time of the observation group was (56.12±1.392min), the average operation time of the control group was (76.84±1.827min); the average blood loss of the observation group was (72.88±2.938ml), and the average blood loss of the control group was (56.16± 2.306ml). The fracture healing time of the observation group was (162.0±7.425) days, and the healing time of the control group was (158.8±8.770) days. (See Figure 1 for details)

As shown in table 1, the average operation time was significantly decreased in the observation group compared to the control group (56.12±1.392min vs 76.84±1.827min, P＜0.05). Meanwhile, the average blood loss in the observation group was significantly increased compared to the control group ( 72.88±2.938ml vs 56.16± 2.306ml, P＜0.05). However, the implicit bleeding was not counted in the control group. Furthermore, no significant difference of postoperative complications and fracture healing time was observed between groups (P>0.05). (See Table 1 for details)

Table 1 Comparison of various indicators between the small incision open reduction group and the closed reduction group（`x±s）

	Number	Surgery time （min）	Blood（ml）	Fracture healing（day）
Observation group	25	56.12±1.392	72.88±2.938	162.0±7.425
Control group	25	76.84±1.827	56.16±2.306	158.8±8.770
P value	0.8647	＜0.0001^*	＜0.0001^*	0.7845

2.3 Complications
One patient in the observation group experienced redness and swelling of the incision at the fracture end with limited exudation. Local infection was considered and successfully treated with prolonged antibiotic use and wound dressing. One patient in the control group developed local skin redness and swelling at the knee joint and was recovered after repeated wound dressing. No serious infection was identified in both groups.
All patients received small incision open reduction surgery achieved, or at least close to, anatomical reduction at the fracture. While all patients in the closed reduction group had a good reduction of the fracture end with alignment accuracy exceeded 80% and limited limb shortening (within 1cm). In addition, no one in the observation group developed internal rotation in the ankle joint and the external rotations were all within 10°.

One patient in the observation group and one in the control group had delayed union of the fracture end after the operation.

A total of 5 patients in the observation group and 4 in the control group complained pain in the knee area after surgery, mainly in the deep part of the anterior knee incision.

2.4 Postoperative function
According to the Johner-Wruhs scoring standard, 18 patients in the observation group fall into the excellent category while 6 in good and 1 in fair categories resulting a 96% rate in achieving good or beyond postoperative function. On the other hand, 18 patients in the control group fall into the excellent category while 5 in good and 2 in fair categories, resulting a 92% rate in achieving good or beyond postoperative function. No significant difference was observed in term of postoperative function (P＞0.05).

Table 2 Comparison of postoperative complications and excellent rate of small incision open reduction group and closed reduction group

	Number	Delay healing（个）	Poor incision healing （个）	Knee pain （个）	The excellent and good rate of Johner-Wruhs（%）
Observation group	25	1	1	5	96
Control group	25	0	0	4	92
P values	-	>0.9999	>0.9999	>0.9999	>0.9999

Case 1: A 55-year-old male who had a fracture in the middle and lower segment of right tibia. A-B, preoperative X-ray: short spiral fracture in the middle of the tibia with dislocation of the fracture end; C-F, open reduction with a small incision, and internal fixation with intramedullary nails. Postoperative X-ray indicated anatomical reduction of the fractured end; G-H, 1 year after operation, follow-up X-ray indicated good fracture healing;

Case 2:A Case 2: 50-year-old male with left calf pain, deformity, and limited movement. A-B, after admission, emergency X-ray revealed transverse fracture of the left tibia and fibula in the middle section, with significant displacement of the fracture end. C-D emergency orthopedic surgeon performed closed reduction and cast fixation. X-ray revealed a slight displacement of the fracture end. E-H, "closed reduction and internal fixation with intramedullary nail", the fibula was not treated. Postoperative X - ray showed good alignment and anatomical condition. I-L, 1 year after surgery, follow-up X-ray showed good fracture healing;

The efficacy and safety of small incision open reduction and intramedullary nail fixation surgery in the treatment of simple tibial shaft fracture

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