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RCT
ACE Report #9163

Percutaneous cannulated screws vs. MIS plate fixation for displaced IA calcaneal fractures


Study Type:Therapy
OE Level Evidence:2
Journal Level of Evidence:N/A

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

BMC Musculoskelet Disord. 2016 Jul 15;17(1):288

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Synopsis

96 patients with a displaced, intraarticular calcaneal fracture were randomized to either a percutaneous reduction and cannulated screw fixation or a minimally invasive sinus tarsi approach for plate and screw fixation. The purpose of this study was to compare functional and radiological outcomes between the two treatment options over a 24-month follow-up. American Orthopaedic Foot and Ankle Society scores overall did not significantly differ between groups, though the subscales of sagittal motion and hindfoot motion significantly favoured the percutaneous reduction and cannulated screw fixation group. With the exception of calcaneal width, groups did not significantly differ in radiographic parameters, either.

Publication Funding Details +
Funding:
Non-Industry funded
Sponsor:
Zhejiang Provincial Medical and Health Technology Project Funding; Zhejiang Provincial Traditional Chinese Medicine Scientific Research Fund Project
Conflicts:
None disclosed

Risk of Bias

4.5/10

Reporting Criteria

17/20

Fragility Index

N/A

Was the allocation sequence adequately generated?

Was allocation adequately concealed?

Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?

Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?

Blinding Patients: Was knowledge of the allocated interventions adequately prevented?

Was loss to follow-up (missing outcome data) infrequent?

Are reports of the study free of suggestion of selective outcome reporting?

Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?

Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?

Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?

Yes = 1

Uncertain = 0.5

Not Relevant = 0

No = 0

The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.

4/4

Randomization

2/4

Outcome Measurements

4/4

Inclusion / Exclusion

4/4

Therapy Description

3/4

Statistics

Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65

The Fragility Index is a tool that aids in the interpretation of significant findings, providing a measure of strength for a result. The Fragility Index represents the number of consecutive events that need to be added to a dichotomous outcome to make the finding no longer significant. A small number represents a weaker finding and a large number represents a stronger finding.

Why was this study needed now?

Open reduction and internal fixation (ORIF) is often used in the management of displaced intraarticular calcaneal fractures. The incidence of postoperative wound-related complications observed with the use of a full-exposure lateral approach has led to the development of alternative strategies. One such method is a minimally invasive sinus tarsi approach, which has demonstrated excellent results in previous trials. A percutaneous reduction, cannulated screw fixation method augmented with a calcium sulfate cement-graft has also been recently developed and demonstrated positive results compared to traditional ORIF. Nevertheless, there has yet to be a comparison between the percutaneous reduction cannulated screw fixation method and minimally invasive sinus tarsi approach to plate fixation.

What was the principal research question?

In the operative management of displaced intra-articular calcaneal fractures, are there any significant differences in functional and radiological outcome between percutaneous reduction and cannulated screw fixation with a calcium sulfate cement-graft versus plate fixation via a minimally invasive sinus tarsi approach when assessed over a 24-month follow-up?

Study Characteristics -
Population:
96 patients, 18 years of age or older, with a closed, Sanders type II-III intra-articular calcaneal fracture scheduled for fixation. Cases of polytrauma were excluded. Postoperative rehabilitation was standardized across groups.
Intervention:
Percutaneous reduction and cannulated screw fixation group: Percutaneous reduction was performed using 6.5mm Schanz pins under fluoroscopic guidance. Once the Bohler's angle and articular surface were reduced satisfactorily, Kirschner wires were used for temporary fixation, and later replaced with 6.5mm and 3.5mm cannulated screws. A calcium sulfate cement-graft was then injected into the bone void to supplement fixation. Hardware was routinely removed at 12 months unless indicated earlier.
Comparison:
Minimally invasive sinus tarsi approach group: A minimally invasive sinus tarsi approach was used for exposure of the fracture. A 3.5mm Steinmann pin was inserted into the calcaneus tuberosity and used to reduce the fracture. Once reduced, the Steinmann pin was advanced into the anterior calcaneus. Once reduction was confirmed on C-arm fluoroscopy, a plate and screws were used for internal fixation. Hardware was routinely removed at 12 months unless indicated earlier.
Outcomes:
Functional outcome was assessed using the American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score. Radiographs and CT were used assess the Bohler's angle, Gissane's angle, and calcaneal height, width, and length. Any complications were documented.
Methods:
RCT; Single-center
Time:
Follow-up scheduled for 6 weeks, and 3, 6, 12, and 24 months postoperatively.

What were the important findings?

  • At final follow-up, mean total AOFAS scores did not significantly differ between the percutaneous reduction and cannulated screw fixation group (84.6+/-6.6) and the minimally invasive sinus tarsi approach group (82.5+/-5.7) (p>0.05). Scores on the sagittal motion and hindfoot motion subscores of the AOFAS were significantly higher in the percutaneous reduction and cannulated screw fixation group compared to the minimally invasive sinus tarsi approach group (p=0.037 and 0.021, respectively).
  • The rate of "good to excellent" outcome on the AOFAS score did not significantly differ overall between the percutaneous reduction and cannulated screw fixation group (34/42) and the minimally invasive sinus tarsi approach group (34/38) (p=0.286). When considering the rate of "good to excellent" outcome in only Sanders type III fracture, the rate was significantly lower in the percutaneous reduction and cannulated screw fixation group (2/10) compared to the minimally invasive sinus tarsi approach group (6/8) (p=0.020).
  • No significant differences between groups at final follow-up were observed for Bohler's angle (p=0.425), Gissanes angle (p=0.724), calcaneal height (p=0.318), or calcaneal length (p=0.059). Calcaneal width was significantly smaller in the minimally invasive sinus tarsi approach group (33.4+/-1.9mm) compared to the percutaneous reduction and cannulated screw fixation group (35.3+/-2.4).
  • The overall incidence of complications was significantly lower in the percutaneous reduction and cannulated screw group (3; 7.1%) compared to the minimally invasive sinus tarsi approach group (11; 28.9%) (p=0.01). Complications in the percutaneous reduction and cannulated screw fixation group included 1 superficial infection and 2 cases of peroneus brevis injury. Complications in the minimally invasive sinus tarsi approach group included 3 superficial infections, 2 deep infections, 1 hematoma, 1 case of wound edge necrosis, 2 sural nerve injuries, and 2 cases of peroneus brevis injury.
  • Operative time was significantly shorter in the percutaneous reduction and cannulated screw fixation group (39.7+/-7.6min) compared to the minimally invasive sinus tarsi approach group (64.2+/-8.6) (p<0.001).

What should I remember most?

In the management of displaced intra-articular calcaneal fractures, overall functional outcome and radiographic outcome after 2 years, with the exception of calcaneal width, were similar between percutaneous reduction and cannulated screw fixation with a calcium sulfate cement bone graft, and plate fixation via a minimally invasive sinus tarsi approach. The recovery of calcaneal width was better following minimally invasive sinus tarsi approach. The percutaneous reduction and cannulated screw fixation group was observed to demonstrate an increased range of motion postoperatively, a lower incidence of complications, and shorter operative time compared to the minimally invasive sinus tarsi approach group.

How will this affect the care of my patients?

The results of this study suggest that operative management through percutaneous reduction and cannulated screw fixation with a calcium sulfate cement bone graft may offer excellent and similar short-term results when compared to plate fixation via a minimally invasive sinus tarsi approach in the management of displaced, intra-articular calcaneal fractures. A shorter procedure time and lower risk of complications may also be attractive advantages to the percutaneous reduction and cannulated screw fixation method. Nonetheless, there was some evidence to suggest that functional outcome in Sanders type III fractures may not be recovered as adequately in cases managed with percutaneous reduction and cannulated screw fixation when compared to the sinus tarsi, plate fixation method. Therefore, there could be the possibility that plate fixation through the minimally invasive sinus tarsi approach may be more appropriately reserved for cases of more severe fracture. Subsequent studies enrolling only specific classifications of fractures would be needed to support this recommendation, however.

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