Abstract
Background
External fixation is an effective treatment for high-energy tibial shaft fractures (HETSFs), often with severe soft tissue damage. The purpose of this study was to provide preliminary insights into potential differences in clinical outcomes between the Carefix Hexaxial Spatial Frame (CHSF) and the Ilizarov Circular External Fixator (ICEF) in the definitive treatment of HETSFs.
Methods
We retrospectively analyzed 46 HETSFs patients, treated with CHSF (n = 26) or ICEF (n = 20), in our department from January 2019 to July 2022. The patient characteristics, operation time, radiological union time, external fixation time, final radiological outcomes, complications, and clinical outcomes were collected and analyzed. Complications that occurred during the treatment were classified according to Paley, which categorizes complications into three groups: problems, obstacles, and sequelae. The final clinical assessment was conducted using the criteria established by the Association for the Study and Application of the Method of Ilizarov (ASAMI) during the patients’ last follow-up visit. The mean follow-up time was 17.2 ± 2.8 months (range 12–24 months).
Results
The CHSF had a significantly shorter operation time (85.9 ± 11.5 min) than the ICEF (95.8 ± 4.2 min) (P < 0.001). Both groups achieved full bone clinical union. Radiological union time was similar: CHSF (24.5 ± 3.2 weeks) vs. ICEF (25.8 ± 3.5 weeks) (P > 0.05). External fixation duration (equivalent to clinical union time) was similar: CHSF (26.0 ± 3.8 weeks) vs. ICEF (26.5 ± 4.1 weeks) (P > 0.05). Translation and angulation in lateral view for the CHSF were all less than those for the ICEF (P < 0.001). Complication rates were comparable: CHSF 57.7%, ICEF 55.0%. No significant difference in ASAMI scores and complication rates was noted between groups at final follow-up (P > 0.05).
Clinical trial number
Not applicable.
Conclusion
In terms of final clinical outcomes, our findings suggest that both CHSF and ICEF may achieve comparable therapeutic effects for HETSFs, with no significant difference in complication rates. CHSF appeared to demonstrate shorter operation times and improved radiological alignment compared to ICEF.
Keywords: Tibial shaft fractures, Carefix hexaxial Spatial frame, Ilizarov circular external fixator
Background
The treatment of high-energy tibial shaft fractures (HETSFs) has long been a subject of clinical interest due to their inherent complexity and the challenges they pose in terms of both fracture and soft tissue management [1]. While non-operative treatment is effective for simple tibial shaft fractures, surgical methods, such as open reduction and internal fixation with plates and screws, are preferred for complex cases. However, these surgical methods can lead to complications such as infections and bone exposure, especially for HETSFs, necessitating careful preoperative preparation and surgical techniques [2, 3]. External fixation was indicated for HETSFs with open fractures, or closed tibial fractures deemed unsuitable for internal fixation due to poor surrounding soft tissue conditions. External fixation techniques, such as the Carefix hexaxial spatial frame (CHSF) and Ilizarov circular external fixator (ICEF), have become the preferred treatment methods for HETSFs due to their minimally invasive nature, adjustability, and preservation of the biomechanical microenvironment around the fracture site. As a result, external fixation was preferred over internal fixation for HETSFs to minimize soft tissue disruption, and allow early weight-bearing [4–6].
There have been many studies on CHSF and ICEF for lower extremity trauma, but comparative studies of these methods for treating HETSFs are rare. Consequently, the potential differences between CHSF and ICEF in treating HETSFs remain unclear [7–9, 11–14, 15]. Given the limitations of retrospective designs in controlling for biases, this study aimed to provide preliminary insights into potential differences in clinical outcomes between CHSF and ICEF for HETSFs by addressing three testable research questions: (1) Does CHSF reduce operation time compared to ICEF? (2) Does CHSF provide improved radiological alignment (AP/lateral translation and angulation) compared to ICEF? (3) Are complication rates (e.g., pin tract infections, nonunion) comparable between CHSF and ICEF?
Methods
The data of 46 patients (27 in right tibia, 19 in left tibia) with HETSFs were retrospectively analyzed in the Department of Traumatic Orthopaedics in Tianjin Hospital between January 2019 and July 2022. 26 patients were treated with CHSF (Shanghai Carefix Medical Instrument Co., Ltd., Shanghai, China) and 20 patients were treated with ICEF (Shanghai Carefix Medical Instrument Co., Ltd., Shanghai, China), including 35 males and 11 females with an average age of 46 years (range 20 to 65 years).
The inclusion criteria were as follows: (1) open fractures (Gustilo-Anderson Type I-IIIB), (2) closed tibial fractures deemed unsuitable for internal fixation due to poor surrounding soft tissue conditions (e.g., severe swelling, extensive contusion, or blistering at the fracture site.), (3) patients treated with CHSF or ICEF as definitive fixation, and (4) surgical operations performed by a fixed team of 5 senior orthopedic surgeons with expertise in external fixation techniques. The same group of physicians performs surgical operations. The exclusion criteria were: (1) fractures accompanied by neurovascular injuries, (2) pathological fractures, (3) congenital or acquired tibial deformities, (4) fractures in other parts of the body, and (5) the follow-up data were incomplete and the follow-up time was less than 12 months, follow-up time was calculated from the date of surgery to the last clinical visit.
This retrospective cohort study was designed to compare CHSF and ICEF in managing high-energy tibial fractures. The ICEF group acted as the control, reflecting its established role as the traditional standard for treating complex fractures [5]. This choice was based on its well-documented efficacy in treating similar fracture types [6], which ensures comparability and relevance to current clinical practices.
The open fractures were classified based on the Gustilo and Anderson classification [3]. The patient characteristics, operation time, radiological union time, external fixation time, final radiological outcomes, complications and clinical outcomes were recorded. Translation and angulation in both anteroposterior (AP) and lateral views were measured using the last available radiographs for both the CHSF and ICEF. The clinical outcomes were evaluated by the ASAMI [16] at the final follow-up. Complications that occurred during the treatment were classified according to Paley’s criteria [17], which categorizes complications into three groups: problems (resolved without surgery, e.g., superficial pin tract infections, temporary joint stiffness), obstacles (requiring surgical intervention, e.g., delayed union needing bone grafting, malalignment requiring frame adjustment), and sequelae (permanent sequelae, e.g., delayed union needing bone grafting, malalignment requiring frame adjustment). The study was proved by the Ethics Committee of Tianjin Hospital (approval no. 2023–088) and was conducted in accordance with the principles of the Declaration of Helsinki.
Preoperative preparation
The tibia fractures with open soft tissue injury underwent debridement in the emergency room and were then transported back to the ward for calcaneal traction.
Under general or epidural anesthesia, the patients were placed in a supine position on the radiolucent operating table and received antibiotic prophylaxis. In cases where patients exhibit unfavorable wound healing progress, we resort to techniques such as skin grafting or flap surgery for intervention.
Surgery method
One or two rings of suitable diameter were positioned at both ends of the tibial fracture line. When two rings were used at one end of the fracture line, they were connected by 3 threaded rods. The ‘ring first’ technique was used in both groups. Each ring was crossed with 2–3 2.0-mm olive wires and reinforced with 1 to 2 6-mm hydroxyapatite (HA)-coated half wires. For the CHSF group, six quick universal adjustment rods connected two sets of rings and were locked after manual reduction. The fracture displacement could be adjusted by measuring the AP and lateral view with the help of computer-based software. For the ICEF group, closed reduction was attempted under the C-arm, stabilized the fracture site if necessary with push-pull wires and arched wires, and fixed the two sets of rings with 4 threaded rods.
Evaluation
The operation time, radiological union time, external fixation time, final radiological outcomes, complications, and clinical outcomes were documented and analyzed between the two groups. Two independent orthopedic surgeons evaluated radiological outcomes, with discrepancies resolved by a senior surgeon. The final clinical assessment was conducted between the two groups at the final follow-up. At the final follow-up, the ASAMI score was employed to assess bone healing and functional recovery. ASAMI criteria classify bone healing into four categories: degree of bone healing, presence or absence of infection, correction of angular deformities, and discrepancy in lower limb length. The overall prognosis is graded as excellent, good, fair, or poor. For lower limb function recovery, ASAMI provides a six-point evaluation scale: restoration of joint mobility, pain level, presence or absence of intermittent claudication, local tissue nutrition, knee and ankle contracture angle, and decrease in knee and ankle joint motion range. This evaluation also results in a prognosis classification of excellent, good, fair, or poor.
Postoperative management
Pin tract care involved the daily application of 75% ethanol to prevent infection, which could be discontinued once the pin tract was dry and non-exudative. Postoperative care began with isometric contraction training of the quadriceps femoris muscle, as well as knee and ankle flexion and extension exercises, starting on the first day. By the second day, patients were encouraged to ambulate with assistance, initially getting out of bed and then progressing to standing and walking with weight bearing using double crutches.
Patients were followed up monthly for radiological and clinical evaluations. The final assessment (including ASAMI scores and complication analysis) was performed at the last follow-up visit, with a mean follow-up of 17.2 ± 2.8 months. Radiological union time was defined as the duration from surgery to radiographic confirmation of bone healing (bridging callus in ≥ 3 cortices on AP/lateral views), time to clinical union was defined as the interval from surgery to pain-free full weight-bearing, extracted from clinical records, which directly corresponded to the external fixation duration. After approximately 1 week of dynamization following radiological union, the external fixator is removed only after achieving clinical union, and thus the external fixation time (26.0 ± 3.8 weeks for CHSF vs. 26.5 ± 4.1 weeks for ICEF) served as a proxy for time to clinical union. Clinical union time was operationally defined as the duration of external fixation, as the fixator was removed exclusively upon confirmation of the clinical union. This approach aligns with prior studies [18] using external fixation as a marker of healing progression. The fixators were removed by the surgical team in the operating room under general anesthesia. All patients were then protected with an inflatable walking boot for 1 month afterward. In cases where the fracture site did not heal, autogenous iliac crest bone grafting was performed.
Statistical analysis
The sample size was determined by the availability of eligible patients during the study period, with no formal a priori calculation.
Data analysis was performed using SPSS 21.0 statistical software (IBM Corp, USA). The normality of continuous variables was assessed using Shapiro-Wilk tests and visual inspection of histograms. For non-normally distributed data, medians with interquartile ranges (IQR) are reported, and Mann-Whitney U tests were used for group comparisons. Continuous variables were analyzed by Independent-samples T-tests and expressed as mean ± standard deviation. Count variables were analyzed by the Chi-square or Fisher’s test, representing as a number. P < 0.05 was considered statistically significant.
Results
This study evaluated 46 patients with HETSFs, with 26 patients in the CHSF and 20 in the ICEF.
Baseline characteristics of the two groups, including gender, age, classification, injury mechanism, open versus closed fracture, Gustilo-Anderson grading, and time from injury to operation, are summarized (Table 1).
Table 1.
Patient characteristics
| Variable | CHSF (n = 26) | ICEF (n = 20) |
|---|---|---|
| Gender | ||
| Male | 20 (76.9%) | 15 (75.0%) |
| Female | 6 (23.1%) | 5 (25.0%) |
| Age (year) | 46.0 ± 12.4 | 41.2 ± 13.7 |
| Injury mechanism | ||
| Traffic accident injury | 17 (65.4%) | 11 (55.0%) |
| High falling injury | 5 (19.2%) | 3 (15.0%) |
| Crushing injury | 3 (11.5%) | 4 (20.0%) |
| Sports injury | 1 (3.9%) | 2 (10.0%) |
| Injured bone | ||
| Left tibia | 11 (42.3%) | 8 (40.0%) |
| Right tibia | 15 (57.7%) | 12 (60.0%) |
| Open/closed fracture | ||
| Open | 18 (69.2%) | 13 (65.0%) |
| Closed | 8 (30.8%) | 7 (35.0%) |
| Compartment syndrome | 1 (3.8%) | 1 (5.0%) |
| Preoperative blisters | 4 (15.4%) | 5 (25.0%) |
| Failed closed reduction | 3 (11.6%) | 1 (5.0%) |
| Gustilo-Anderson grading | ||
| Type I | 2 (7.7%) | 1 (5.0%) |
| Type II | 10 (38.5%) | 4 (20.0%) |
| Type IIIA | 5 (19.2%) | 7 (35.0%) |
| Type IIIB | 1 (3.9%) | 1 (5.0%) |
| Time from injury to operation (day) | 3.5 ± 1.9 | 3.7 ± 1.8 |
Data are presented as mean ± SD or n (%). No statistical tests were performed for baseline comparisons, as recommended for observational studies. Data on smoking, alcohol use, diet, and occupation were not systematically collected in this retrospective study
Among 15 closed fractures (CHSF: 8; ICEF: 7), complications included: Osteofascial compartment syndrome: CHSF 1/8 (12.5%) vs. ICEF 1/7 (14.3%). Preoperative blisters: CHSF 4/8 (50.0%) vs. ICEF 5/7 (71.4%). Failed closed reduction: CHSF 3/8 (37.5%) vs. ICEF 1/7 (14.3%).
In 3 Type I cases and 12 Type II cases, direct debridement and suturing were applied to handle the open wounds; in 2 Type II cases and 12 Type IIIA cases, Vacuum sealing drainage (VSD) and skin grafting were applied after wound closure; in 2 Type IIIB cases, saphenous nerve flap was applied. The osteofascial compartment syndrome was cured by timely incision to reduce tension and dressing changes in the first stage, skin grafting and external fixation of fractures in the second stage.
The mean operation time in the CHSF group (85.9 ± 11.5 min) was shorter than that in the ICEF group (95.8 ± 4.2 min) (P < 0.001). All patients successfully achieved complete bone clinical union. Radiological union time was similar: CHSF (24.5 ± 3.2 weeks) vs. ICEF (25.8 ± 3.5 weeks) (P > 0.05). The mean external fixation time (equivalent to clinical union time) was (26.0 ± 3.8 weeks) for the CHSF group and (26.5 ± 4.1 weeks) for the ICEF group (P>0.05). The Follow-up time was (16.6 ± 2.5 months) for the CHSF group and (17.7 ± 3.2 months) for the ICEF group (P>0.05). (Table 2).
Table 2.
Clinical and radiological results at the final follow-up
| Variable | CHSF | ICEF | P value |
|---|---|---|---|
| Operation time (min) | 85.9 ± 11.5 | 95.8 ± 4.2 | P < 0.001 |
| Radiological union time (week) | 24.5 ± 3.2 | 25.8 ± 3.5 | 0.202 |
| External fixation time/ Clinical union time (week) | 26.0 ± 3.8 | 26.5 ± 4.1 | 0.674 |
| Follow-up time (month) | 16.6 ± 2.5 | 17.7 ± 3.2 | 0.211 |
| Radiological results | |||
| Translation in AP view (mm) | 1.3 ± 0.9 | 1.7 ± 1.1 | 0.325 |
|
Translation in lateral view (mm) (mm) |
0.9 ± 1.2 | 1.8 ± 1.3 | P < 0.001 |
|
Angulation in AP view (°) (°) |
0.9 ± 0.8 | 1.2 ± 0.7 | 0.271 |
|
Angulation in lateral view (°) (°) |
1.8 ± 0.9 | 2.9 ± 1.2 | P < 0.001 |
After tibial fracture union, the AP and lateral view were analyzed, and the mean translation and angulation in the AP view for the CHSF group were (1.3 ± 0.9) mm, (0.9 ± 0.8) °, respectively. The mean translation and angulation in AP view for the ICEF group were (1.7 ± 1.1) mm, (1.2 ± 0.7) °, respectively. No significant differences in the two groups concerning translation and angulation in AP view (P > 0.05) were found. As for the lateral view, the mean translation and angulation were (0.9 ± 1.2) mm and (1.8 ± 0.9) ° in the CHSF group, while (1.8 ± 1.3) mm and (2.9 ± 1.2) ° in the ICEF group. Translation and angulation in lateral view for the CHSF group were all less than that for the ICEF group (P < 0.001) (Table 2).
When the superficial pin tract infection was observed, daily pin tract care and oral antibiotics were administered to the 10 cases in the CHSF and the 7 cases in the ICEF, and there was no deep infection in the two groups. 2 cases in the CHSF suffered delayed union and were cured by installing 2 threaded rods and compressing the fracture site to improve stability, and the fracture ultimately healed. 2 case suffered nonunion in the ICEF, and the bone union was finally made by using autogenous iliac crest bone grafting. 3 cases in the CHSF and 2 cases in the ICEF experienced joint stiffness and were resolved by functional exercises. According to Paley’s classification, the problem rates were 50.0% (CHSF) and 45.0% (ICEF), the obstacle rates were 7.7% (CHSF) and 0% (ICEF), and the complication rates were 0% (CHSF) and 10.0% (ICEF). Complication rates were 57.7% in the CHSF, compared to 55.0% in the ICEF. No significant difference in complication rates was noted between groups (P > 0.05) (Table 3).
Table 3.
Complications of the two groups
| Variable | CHSF (%) | ICEF (%) | P value |
|---|---|---|---|
| Complication | |||
| Pin tract infection | 10 (38.5) | 7 (35) | 0.813 |
| Osteomyelitis | 0 (0) | 0 (0) | 1.000 |
| Malreduction | 0 (0) | 0 (0) | 1.000 |
| Delayed union | 2 (7.7) | 0 (0) | 0.494 |
| Nonunion | 0 (0) | 2 (10.0) | 0.494 |
| Joint stiffness | 3 (11.5) | 2 (10.0) | 1.000 |
| Category | |||
| Problems | 13 (50.0) | 9 (45.0) | 0.787 |
| Obstacles | 2 (7.7) | 0 (0) | 0.494 |
| Sequelae | 0 (0) | 2 (10.0) | 0.494 |
| Complication rate | 57.7% | 55.0% | 0.826 |
Problems: resolved without surgery, obstacles: requiring surgical intervention, complications: permanent sequelae
At the final follow-up, based on the ASAMI bone results, in the CHSF, 20 cases showed excellent results, 5 cases had good results, and 1 case experienced fair results. In the ICEF, 16 cases achieved excellent results, 2 cases had good results, 1 case had a fair result, and 1 case experienced poor results. Based on the ASAMI functional results, in the CHSF, 14 cases showed excellent results, 10 cases had good results, and 2 cases experienced fair results. In the ICEF, 12 cases achieved excellent results, 5 cases had good results, and 3 cases had fair results. No statistically significant distinctions were observed in ASAMI scores between the two groups (P > 0.05). (Table 4).
Table 4.
Outcomes of ASAMI scores in the two groups
| Variable | Excellent | Good | Fair | Poor | Failure | P value |
|---|---|---|---|---|---|---|
| Bone scores | 0.576 | |||||
| CHSF | 20 | 5 | 1 | 0 | 0 | |
| ICEF | 16 | 2 | 1 | 1 | 0 | |
| Functional scores | 0.533 | |||||
| CHSF | 14 | 10 | 2 | 0 | 0 | |
| ICEF | 12 | 5 | 3 | 0 | 0 |
Two typical cases in CHSF and ICEF treatment are shown in Figs. 1 and 2.
Fig. 1.
Images of treating a 36-year-old male with HETSFs due to high falling using CHSF. a, b X-ray images of injured HETSFs preoperatively. c, d Computer tomography images of injured HETSFs preoperatively. e Appearance image shows poor local soft tissue conditions in the right lower leg preoperatively. f, g X-ray images show tibial fracture displacement 1 day after surgery. h, i X-ray images show satisfactory reduction of tibial fracture with the help of computer software. j, k X-ray images show good fracture union, one week after removal of CHSF. l, m Clinical follow-up appearance images, obtained 1 month after CHSF removal
Fig. 2.
Images of treating a 42-year-old female with HETSF due to a traffic accident by using ICEF. a, b X-ray images of injured HETSFs preoperatively. c, d Computer tomography images of injured HETSFs preoperatively. e Appearance images show poor local soft tissue conditions in the right lower leg preoperatively.f, g X-ray images show satisfactory reduction of tibial fracture. h, i Appearance images show external fixation in the right lower leg postoperatively. j, k X-ray images show good fracture union, one week after removal of ICEF
Discussion
Both CHSF and ICEF have achieved satisfactory outcomes in the treatment of HETSFs [10, 11, 18–21]. However, our study demonstrated that CHSF significantly reduced operation time (85.9 ± 11.5 vs. 95.8 ± 4.2 min, P < 0.001) and improved radiological alignment in lateral view (translation: 0.9 ± 1.2 vs. 1.8 ± 1.3 mm, P < 0.001; angulation: 0.9 ± 0.8 vs. 1.2 ± 0.7 P < 0.001) compared to ICEF, while complication rates (57.7% vs. 55.0%) and functional recovery (ASAMI scores) showed no significant differences. The efficiency of CHSF aligns with its computer-assisted reduction system [4], whereas ICEF’s reliance on manual adjustments [5] may explain prolonged operation times. While ASAMI functional scores showed no intergroup difference, CHSF’s improved lateral alignment may reduce long-term osteoarthritis risk—a hypothesis warranting validation through extended follow-up [22].
Complications
Pin tract infections emerged as the predominant challenge in both groups (CHSF: 38.5% vs. ICEF: 35%), aligning with reported rates of 30–40% in external fixation systems for tibial fractures [21]. Notably, our rates were lower than the 45% observed by Tucker et al. [11] in hexapod frame applications, potentially attributable to our standardized protocol of daily ethanol care, which has demonstrated efficacy in reducing bacterial colonization [11]. Furthermore, the CHSF’s computer-assisted reduction may indirectly mitigate soft tissue trauma, thereby lowering infection risk—a mechanism supported by Liu et al. [7]. These findings underscore the importance of integrating technological advancements with evidence-based postoperative care [5] to optimize outcomes in high-energy trauma settings.
Knee or ankle joint stiffness is also a common problem after external fixation technology for treating proximal or distal tibial fractures [23]. Joint stiffness rates in CHSF and ICEF groups were similar (11.5% and 10.0%, respectively). This similarity in rates may be attributed to the comparable duration of external fixation in both groups: 26.0 ± 3.8 weeks for the CHSF and 26.5 ± 4.1 weeks for the ICEF. In this study, knee joint stiffness was observed in 2 patients and ankle joint stiffness in 3 patients, all of whom experienced improvement following exercise guidance. The occurrence of joint stiffness may result from the insertion of wires near the knee or ankle joints, which can restrict their range of motion. Consequently, it is essential to preserve the range of motion of the knee or ankle joint as much as possible when inserting wires.
In the CHSF group, 2 patients experienced delayed union of the fracture, which might have been related to slight postoperative instability caused by micro-movement of the universal adjustment rods. This aligns with prior studies reporting that insufficient initial stability significantly prolongs healing time in external fixation systems [11]. Therefore, when applying CHSF, it is advisable to use rigid fixation in the early stage to enhance the stability of the fracture fixation. Notably, delayed union rates in our cohort (7.7%) were comparable to those reported by Tafazal et al. [20] using similar hexapod frames (5–10%). Additionally, in the ICEF group, there were 2 cases of nonunion, which might be associated with the disruption of the biomechanical microenvironment around the fracture site due to repeated reduction attempts [24–26]. These fractures were ultimately healed following autologous iliac bone grafting. Notably, no cases of delayed union were observed in the ICEF group, which may be attributed to the use of push-pull and arched wires that reduce shear forces and improve stability [27]. However, confounding factors such as smoking or metabolic comorbidities (e.g., diabetes) were not systematically recorded, which may influence healing outcomes as suggested by Fowler et al. [24].
The use of Paley’s classification allowed nuanced categorization of complications, distinguishing temporary issues (problems) from surgically addressable obstacles and permanent complications. This framework enhances comparability with prior studies [7].
The AP and lateral view
The CHSF’s ability to achieve improved alignment postoperatively aligns with studies by Henderson et al. [4], who attributed this precision to computer-assisted reduction systems. However, our observation of residual lateral view discrepancies in ICEF (translation: 1.8 ± 1.3 mm vs. CHSF: 0.9 ± 1.2 mm, P < 0.001; angulation: 2.9 ± 1.2° VS. CHSF: 1.8 ± 0.9°, P < 0.001) echoes findings by Rogers et al. [5], who noted similar challenges in manual reduction techniques for complex tibial fractures. This discrepancy might be attributed to the ICEF, where manual reduction can lead to instability along the fracture line due to an emphasis on the AP view while potentially overlooking the lateral view. The ICEF’s reliance on manual reduction under fluoroscopy, as described by Liu [7], inherently increases the risk of residual malalignment, particularly in lateral views. If the displacement of the tibial fracture cannot be restored to anatomic reduction during surgery, it becomes more challenging to correct any residual deformity using threaded rods postoperatively. Therefore, when applying ICEF, it is crucial to consider both the AP and lateral views.
Previous studies suggest that lateral angulation > 5° may increase osteoarthritis risk [22]. In our cohort, ICEF angulation (2.9 ± 1.2°) and CHSF angulation (1.8 ± 0.9°) were both below this threshold. However, CHSF’s closer alignment to anatomical reduction may further mitigate long-term degenerative changes. Although both groups achieved acceptable alignment, CHSF’s superior lateral reduction (0.9 ± 1.2 mm vs. 1.8 ± 1.3 mm, P < 0.001) may reduce abnormal joint loading, potentially delaying post-traumatic osteoarthritis [22]. The smaller translational discrepancy in CHSF could also minimize soft tissue irritation, improving postoperative comfort [7].
Limitations
The present study has several limitations. Firstly, our study inherently possesses bias due to its retrospective comparative nature, which introduces randomness between the two groups, and inevitable selection bias, and the lack of a priori sample size calculation is a key limitation, potentially increasing the risk of Type II errors. Therefore, the results of this study warrant validation through a prospective randomized controlled trial. Second, the study is single-center, and the sample size is small, which may lead to deviations in the outcomes of the statistical analysis. Therefore, it is necessary to expand the sample size to enrich this study, and even multi-center studies to obtain more accurate conclusions. Thirdly, this study conducted a comparative analysis with a short follow-up time. Consequently, it was unable to evaluate long-term outcomes. Future studies should consider extending the follow-up duration for a more comprehensive evaluation. Fourthly, this study did not collect data on key prognostic factors such as smoking, alcohol consumption, dietary habits, or occupational activities. These variables could influence fracture healing rates and functional outcomes, potentially confounding our results. Future studies should incorporate these factors to enhance the robustness of comparative analyses. Fifthly, the distribution of Gustilo-Anderson types is the uneven between groups. Although no significant differences in complications were observed, this imbalance may introduce confounding. Future studies with larger cohorts or stratified designs are needed to clarify this relationship. Nevertheless, this study directly compared the final clinical outcomes of CHSF and ICEF in the treatment of HETFs and preliminarily concluded.
Conclusion
In terms of final clinical outcomes, our findings suggest that both CHSF and ICEF may achieve comparable therapeutic effects for HETSFs, with no significant difference in complication rates. CHSF appeared to demonstrate shorter operation times and improved radiological alignment compared to ICEF.
Acknowledgements
Not applicable.
Abbreviations
- HETSFs
High-energy tibial shaft fractures
- CHSF
Carefix hexaxial spatial frame
- ICEF
Ilizarov circular external fixator
- ASAMI
The Association for the Study and Application of the Method of Ilizarov
- VSD
Vacuum sealing drainage
- AP
Anteroposterior
- HA
Hydroxyapatite
Author contributions
ZMZ: Conducted the study. Collected, analyzed and interpreted the data. Wrote the manuscript. XC: Interpreted and analyzed the data. Edited the manuscript. FG: Interpreted and analyzed the data. Edited the manuscript. YBL: Created and statistically analyzed the data. Edited the manuscript. BWS: Conducted the study and provided the data. GQJ: Provided software assistance. CGC: Conducted the study and provided the data. WGX: Planned the project. Reviewed the manuscript.
Funding
None.
Data availability
A reasonable request for the datasets used in the current study can be made to the corresponding author.
Declarations
Ethics approval and consent to participate
The present study was approved by the Ethics Committee of Tianjin Hospital (approval no. 2023–088), and was conducted in accordance with the principles of the Declaration of Helsinki. All patients gave their written informed consent.
Consent for publication
All patients gave written informed consent for publication.
Competing interests
The authors declare no competing interests.
Footnotes
Publisher’s note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
A reasonable request for the datasets used in the current study can be made to the corresponding author.