Comparison of percutaneous cannulated screw fixation and calcium sulfate cement grafting versus minimally invasive sinus tarsi approach and plate fixation for displaced intra-articular calcaneal fractures: a prospective randomized controlled trial
© The Author(s). 2016
Received: 26 February 2016
Accepted: 9 June 2016
Published: 15 July 2016
The management of displaced intra-articular calcaneal fractures (DIACFs) remains challenging and controversial. A prospective randomized controlled trial was conducted to compare percutaneous reduction, cannulated screw fixation and calcium sulfate cement (PR+CSC) grafting with minimally invasive sinus tarsi approach and plate fixation (MISTA) for treatment of DIACFs.
Ultimately, 80 patients with a DIACFs were randomly allocated to receive either PR+CSC (N = 42) or MISTA (N = 38). Functional outcomes were evaluated using the American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot scores. Radiological results were assessed using plain radiographs and computed tomography (CT) scans, and postoperative wound-related complications were also recorded.
The average time from initial injury to operation and the average operation time in the PR+CSC group were both significantly shorter than those in the MISTA group (p < 0.05). There were significantly fewer complications in the PR+CSC group than those in the MISTA group (7.1 % vs 28.9 %, p < 0.001). The calcaneal width immediate postoperatively and at the final follow-up in the MISTA group were obviously improved compared to those in the PR+CSC group (p < 0.001). The variables of sagittal motion and hindfoot motion of the AOFAS scoring system in the PR+CSC group were significantly higher than those in the MISTA group (p < 0.05). The good and excellent results in the two groups were comparable for Sanders Type-II calcaneal fractures, but the good to excellent rate in the MISTA group was significantly higher for Sanders Type-III fractures (p < 0.05).
The clinical outcomes are comparable between the two minimally invasive techniques in the treatment of Sanders Type-II DIACFs. The PR+CSC grafting is superior to the MISTA in terms of the average time between initial injury and operation, operation time, wound-related complications and subtalar joint activity. However, the MISTA has its own advantages in improving the calcaneal width, providing a more clear visualization and accurate reduction of the articular surface, especially for Sanders Type-III DIACFs.
ChiCTRIOR16008512. 21 May 2016.
KeywordsCalcaneus Intra-articular fractures Minimally invasive Percutaneous fixation Sinus tarsi approach Randomized controlled trial
The management of displaced intra-articular calcaneal fractures (DIACFs) remains challenging and controversial . Open reduction and internal fixation (ORIF) through an extensile lateral approach has been widely accepted and established as a standard treatment for DIACFs [2, 3]. However, a fairly high wound-related complication rate has been reported with this approach, including wound edge necrosis, dehiscence, hematoma, infection and injury to the sural nerve [4–7].
In an attempt to lower the complication rate, various minimally invasive techniques have recently been introduced, including external fixation, percutaneous fixation, arthroscopically assisted fixation, and minimal incision techniques via medial, modified lateral (such as the sinus tarsi approach), longitudinal, or combined approaches [8–14]. These techniques have been reported as effective in minimizing soft tissue trauma, thereby reducing the incidence of wound-related complications.
As one of the most popular and effective minimally invasive techniques, the sinus tarsi approach not only can fully expose the posterior facet and the anterolateral fragment, but it also significantly reduces the incidence of postoperative wound complications [11, 12, 15]. In order to further shorten the operative time and decrease the wound complication rate, we introduced, in 2006, percutaneous reduction, cannulated screw fixation and calcium sulfate cement (CSC) grafting. A preliminary clinical study carried out by our team found that compared with the traditional L-shaped extensile lateral approach, this new technique allowed earlier weight-bearing, reduced subtalar joint stiffness and a reduced wound complication rate, while improving the patients’ satisfaction . The purpose of the present study was to compare the functional and radiological outcomes and complications of our percutaneous reduction, cannulated screw fixation and CSC grafting with those of the minimally invasive sinus tarsi approach and plate fixation for treatment of DIACFs.
Patients with a Sanders Type-II or Type-III calcaneal fracture, who were the consecutive candidates for surgical treatment at our hospital from January 2009 to December 2011, were randomly allocated to either the percutaneous reduction, cannulated screw fixation and CSC grafting (the PR+CSC group) or the minimally invasive sinus tarsi approach and plate fixation (the MISTA group). The patients were randomly divided into the two groups using coin tossing method. Three senior surgeons were randomly assigned to each group to perform the surgeries using either surgical method.
The inclusion criteria were: 1) unilateral Sanders Type-II or Type-III intra-articular calcaneal fracture; 2) the age was greater than or equal to 18 years old; and 3) closed fracture. The exclusion criteria were: 1) severe medical ailments (severe vascular or neurologic injury, diabetes) or contraindications (known local or systemic infection); 2) Sanders Type-IV, bilateral or open calcaneal fractures; 3) severe and polytraumatic injuries or polytrauma of the ipsilateral lower limb when admitted; and 4) refused to accept the treatment plan. All patients agreed to participate in this clinical trial by signing an informed consent form. The study was approved by the Ethical Board Review of the Second Affiliated Hospital of Wenzhou Medical University (Wenzhou, Zhejiang, China), and was performed in accordance with the ethical standards of the Declaration of Helsinki of 1964.
All patients were evaluated using preoperative calcaneal radiographs and computed tomography (CT) scans and two-dimensional reconstruction of the injured foot. The swelling of the hindfoot did not need to subside if the patients were randomly assigned to the PR+CSC group. All surgeries were performed with patients placed in the lateral decubitus position under either epidural or spinal anesthesia. Tourniquets were applied routinely.
All patients in both groups underwent the same postoperative management protocol. The patients were encouraged to do non-weight-bearing exercises including extension and plantar flexion as early as the pain could be endured and use crutch while walking two or three days postoperatively. Partial weight-bearing was permitted at four weeks post-operation and then progressed gradually. Full weight-bearing was not allowed until bony union confirmed on radiographs, which was around three months postoperatively. Each patient received follow-up at 6 weeks, 3, 6, and 12 months post-operation, and then yearly thereafter.
The functional outcomes were assessed using the American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot scores  at the 24-month follow-up. The postoperative wound-related complications were also recorded.
Lateral and axial radiographs and CT scans were obtained immediately post-operation to assess the reduction of the articular surface and the fracture fixation. Physical examination and lateral and axial radiographs of the injured foot were performed at each follow-up evaluation. The calcaneal anatomical parameters, including Böhlers angle, Gissanes angle, height, width, and length were measured by radiographs or CT scans postoperatively and at the final follow up. Hardware was removed from each patient at 12 months postoperatively, unless the patient had indications for earlier hardware removal.
Statistical analysis was performed with SPSS 17.0 software for Windows. Continuous data with a normal distribution were expressed as the mean ± standard deviation. The Mann-Whitney U test and non-paired t test were used to compare differences continuous variables with non-normal distributions and approximately normally distributed respectively. Categorical data were statistically analyzed by Chi-square test or Fisher’s exact test (n < 40 or t < 1). A p value of < 0.05 was considered statistically significant.
Comparison of the general characteristics of the two groups
N = 42
N = 38
39.5 ± 10.5
40.7 ± 10.3
Side of injured
Time to operation (days)
2.9 ± 1.1
4.3 ± 1.4
Operation time (min)
39.7 ± 7.6
64.2 ± 8.6
The functional outcome according to AOFAS scores for the two groups
(x ± s)
(x ± s)
34.0 ± 6.3
33.2 ± 6.2
8.4 ± 1.9
8.2 ± 1.9
3.9 ± 1.5
3.8 ± 1.3
6.0 ± 2.5
5.8 ± 2.4
Sagittal motion (flexion plus extension)
7.0 ± 1.8
6.0 ± 2.2
Hindfoot motion (inversion plus eversion)
5.3 ± 1.3
4.5 ± 1.7
84.6 ± 6.6
82.5 ± 5.7
Good to excellent results in the two groups according to the Sanders classification
Type (II+ III)
32 (100 %)
2 (20 %)
34 (81.0 %)
28 (93.3 %)
6 (75 %)
34 (89.5 %)
Comparison of the postoperative wound-related complications in the two groups
1 (2.4 %)
7 (18.4 %)
Sural nerve injury
2 (5.3 %)
Musculus peroneus brevis injury
2 (4.7 %)
2 (5.3 %)
3 (7.1 %)
11 (28.9 %)
Radiographic results for the two groups
(x ± s)
(x ± s)
Böhler angle (deg)
2.1 ± 5.5
2.2 ± 7.0
30.3 ± 4.0
30.4 ± 3.3
28.6 ± 3.6
29.2 ± 3.5
Gissanes angle (deg)
93.5 ± 7.4
93.3 ± 7.5
120.2 ± 7.2
119.9 ± 6.0
117.1 ± 6.8
117.6 ± 6.1
Calcaneal width (mm)
39.8 ± 2.6
39.1 ± 2.5
34.7 ± 2.2
33.0 ± 1.8
35.3 ± 2.4
33.4 ± 1.9
Calcaneal height (mm)
31.4 ± 4.2
30.9 ± 3.6
40.3 ± 5.4
40.6 ± 4.6
38.7 ± 2.7
39.3 ± 3.1
Calcaneal length (mm)
63.5 ± 2.1
63.2 ± 2.8
67.9 ± 4.3
69.1 ± 2.7
66.9 ± 3.9
68.2 ± 2.6
The mean time from surgery to partial weight-bearing was comparable between the PR+CSC group and the MISTA group (6.2 weeks vs 6.0 weeks; p < 0.05). At the last follow-up, posttraumatic subtalar arthritis was observed in two patients in the PR+CSC group and one patient in the MISTA group as shown by radiographs.
The optimal management of displaced intra-articular calcaneal fractures remains controversial . An increasing number of studies have shown a trend toward better functional outcomes in the operatively managed groups than those treated non-operatively [18, 19]. However, the high concern about wound-related complications with the extensile lateral L-shaped approach has troubled many orthopedic surgeons . The complication rate after surgical treatment has been reported to range from 11 to 25 % [4–7, 20, 21]. As one of the most widely applied minimally invasive techniques, the sinus tarsi approach has the advantage of direct visualization of the posterior articular facet and fewer wound-related complications [11, 12, 15]. In order to minimize the wound-related complications and explore the optimal treatment for DIACFs, in 2006, we introduced percutaneous reduction, cannulated screw fixation and CSC grafting for treatment of DIACFs. We reported the first clinical data using this technique to treat 90 patients with 90 DIACFs in an article published in 2011 . We found that, compared with ORIF, this minimally invasive technique allowed earlier weight bearing, reduced subtalar joint stiffness, and improved patient satisfaction. To further optimize the minimally invasive percutaneous technique in the treatment of DIACFs, in this study, we aimed to compare the functional outcomes, radiographic results and the postoperative wound-related complications between the minimally invasive percutaneous fixation and the minimally invasive sinus tarsi approach.
The assessment of functional outcomes in our study revealed an overall good to excellent rate of 81.0 % in the PR+CSC group compared with 89.5 % in the MISTA group. The mean AOFAS score was 84.6 in the PR+CSC group, which was higher than that 82.5 in the MISTA group. However, both differences were not statistically significant. There was also no significant difference between the two groups in terms of the good to excellent rate for Sanders Type-II fractures. Wang YM et al. reported percutaneous reduction and Steinman pin fixation minimized complications and achieved functional outcomes comparable to those of the open techniques in patients with Sanders Type-II calcaneal fractures . For Sanders Type-III fractures, however, the MISTA group could achieve better functional outcomes than the PR+CSC group. For this reason, we believed that the minimally invasive sinus tarsi approach was superior to the percutaneous cannulated screw fixation in acquiring a better articular surface reduction, especially for Sanders Type-III fractures. Thus different functional outcomes may be attributed to different qualities of articular reduction. Consistently, Mulcahy et al. also suggessted that a minor residual step-off of the posterior facet could cause a significant load shift within the subtalar joint , which might have an adverse effect on functional outcome [24, 25]. Therefore, using the percutaneous reduction and cannulated screw fixation to treat comminuted calcaneal fractures may carry a risk of inadequate reduction of the articular surface.
The results analysis from the partial variables of the AOFAS scoring system suggested that patients in the PR+CSC group suffered from less pain, less activity limitations, less gait abnormality, and less demand on walking surfaces. Meanwhile, they obtained better sagittal motion and hindfoot motion than patients in the MISTA group. However, the difference was only statistically significant for two variables; sagittal motion and hindfoot motion, which suggests, compared with the minimally invasive sinus tarsi approach, that percutaneous reduction and cannulated screw fixation may be more minimally invasive and favor earlier and painless functional exercise.
The radiographic results revealed the significant differences between the two groups in terms of the calcaneal width immediately postoperatively and at the final follow-up. Therefore, the role of the percutaneous reduction and cannulated screw fixation restoring the calcaneal width was weaker than the minimally invasive sinus tarsi approach. Although it is known that the widened calcaneus is the main reason for patients suffering from lateral impingement syndrome [26–28], the difference in the overall functional outcomes between the two groups was not statistically significant. Our data suggested that the reduction of the posterior articular surface might be the most important factor associated with the functional outcome of calcaneal fractures [3, 24, 25].
The wound-healing complication rate was significantly lower in the PR+CSC group than that in the MISTA group (2.4 vs 18.4 %). The minimized disturbance to the blood supply and the soft tissue of the lateral aspect of the calcaneal , coupled with the significantly shorter operative time, may have contributed to the lower rate of wound-healing complications in the PR+CSC group. Furthermore, the PR+CSC group had a lower risk of sural nerve injury and musculus peroneus brevis injury compared with the MISTA group, however, the difference was not statistically significant. Although the overall complication rate was found to be quite high in the MISTA group, most of the complications appeared in the early days. The complication rate decreased significantly as our experience improved and the waiting time to operation extended.
There are a few limitations in this study. First, we had a relatively small number of patients and short average follow-up time. Therefore, further investigation with a larger sample size and longer follow-up time is needed to obtain more overall clinical data. In addition, the differences in surgeons’ performances might have decreased the generalization power of this study. Assigning all the patients to only one surgeon would be much beneficial to reduce the variability caused by the surgeon’s performance, but this would be practically impossible in our hospital. Furthermore, the quality of joint surface reduction was not specifically analyzed or compared between the two groups. It needs to be studied further.
The percutaneous reduction, cannulated screw fixation and CSC grafting for treatment of Sanders Type-II DIACFs can achieve almost equivalent functional outcomes compared with the minimally invasive sinus tarsi approach and plate fixation. The two techniques have their own advantages. The PR+CSC grafting is superior to the MISTA procedure in terms of the average time between initial injury and operation, operation time, wound-related complications and subtalar joint activity. However, the MISTA procedure has its own advantages in improving the calcaneal width, providing clear visualization and more accurate reduction of the articular surface, especially for Sanders Type-III DIACFs. The functional outcomes of Sanders Type-III DIACFs treated by MISTA excelled the PR+CSC grafting.
AOFAS, American Orthopaedic Foot and Ankle Society; CONSORT, Consolidated Standards of Reporting Trials; CSC, calcium sulfate cement; CT, computed tomography; DIACFs, displaced intra-articular calcaneal fractures; MISTA, minimally invasive sinus tarsi approach; ORIF, open reduction and internal fixation; PR, percutaneous reduction
This research was supported by Zhejiang provincial medical and health technology project funding (No.2016KYA138) and Zhejiang provincial traditional chinese medicine scientific research fund project (No. 2016ZA141).
Availability of data and materials
The datasets supporting the conclusions of this article are included within the article.
YF, XS, JW, and JH initiated the study design. JH is the principal investigator. YY is the programme coordinator. YY conceived the intervention and, with the support of XY, is responsible for execution of the intervention, recruitment of participants and the administration of the study. JK helps to coordinate data collection. LC and YF help with the recruitment and, together with JK, provide clinical expertise. All authors are ICH/GCP certified and contributed to the study protocol and approved the final manuscript.
The authors declare that they have no competing interest.
Ethics and consent to participate
All patients agreed to participate in this clinical trial by signing an informed consent form. The study was approved by the Ethical Board Review of the Second Affiliated Hospital of Wenzhou Medical University.
The manuscript was prepared according to CONSORT 2010 guidelines.
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