Sustentaculum Tali Screw Fixation Mode and Postoperative Foot-Ankle Function in Calcaneal Fractures

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorPeking University Third Hospital

About this trial

This is an observational, ambidirectional cohort study. Calcaneal fractures are the most common tarsal bone fractures, and most are intra-articular fractures involving the subtalar joint. Surgery with open reduction and internal fixation is the standard treatment for displaced intra-articular calcaneal fractures. During surgery, a sustentaculum tali screw is placed from the lateral wall of the calcaneus toward the medial side to support the reduced posterior articular surface. Depending on the screw tip position, fixation is classified as sustentaculum tali fixation (ST; screw fixed directly into the sustentaculum tali) or sustentaculum tali fragment fixation (STF; screw fixed into the larger medial fragment containing the sustentaculum tali). This study compares radiographic reduction quality, foot and ankle function, and complications between these two fixation groups. Approximately 92 participants with intra-articular calcaneal fractures will be enrolled, retrospectively from January 2015 to August 2026 and prospectively from September 2026. The fixation mode is determined on postoperative X-rays. Outcomes, including the Maryland Foot Score, the AOFAS ankle-hindfoot score, Böhler's angle, Gissane's angle, calcaneal height and width, and complications, will be compared between groups over at least 12 months of follow-up. No randomization is performed and no treatment is altered by this study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

The study population consists of adults with intra-articular calcaneal fractures who underwent open reduction and internal fixation at Peking University Third Hospital. Retrospective cases will be identified from January 2015 to August 2026, and prospective cases will be enrolled from September 2026 onward. Participants will be classified into the ST or STF group according to screw tip position on postoperative lateral and axial X-rays. Approximately 92 participants are expected. No treatment is assigned by the study; all participants receive routine clinical care.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Screw Tip Position Relative to the Sustentaculum Tali

    Other intervention

    Postoperative screw tip position on lateral and axial X-rays, classified as either ST (within the sustentaculum tali) or STF (in the larger medial fragment, outside the sustentaculum tali range). This is the exposure of interest; the study does not assign this exposure.

Treatment groups

92 Participants
are divided into 2 treatment groups
Group A: Sustentaculum Tali (ST) Fixation1 intervention
Group B: Sustentaculum Tali Fragment (STF) Fixation1 intervention

Trial outcomes

Primary outcomes

1

Maryland Foot Score

A validated 100-point scoring system for assessing foot function after injury. Domains include pain, gait, distance walked, stability, support, limp, and wearing shoes. Higher scores indicate better function. Score categories: Excellent 90-100; Good 75-89; Fair 50-74; Failure \<50.

Time frame
At least 12 months postoperatively
2

AOFAS Ankle-Hindfoot Score

A validated 100-point scoring system for assessing ankle and hindfoot function. Comprises three domains: pain (40 points), function (50 points), and alignment (10 points). Higher scores indicate better function. Score categories: Excellent 90-100; Good 80-89; Fair 65-79; Poor \<65.

Time frame
At least 12 months postoperatively

Secondary outcomes

1

Change in Böhler's Angle

Change in Böhler's angle measured on lateral X-rays. Böhler's angle is formed by the intersection of a line from the highest point of the anterior process to the highest point of the posterior facet and a line from the highest point of the posterior facet to the superior margin of the calcaneal tuberosity. Normal range is approximately 20°-40°. A decrease indicates loss of calcaneal height and posterior facet collapse.

Time frame
Preoperative, immediate postoperative, and at least 12 months postoperatively
2

Change in Gissane's Angle

Change in Gissane's angle measured on lateral X-rays. Gissane's angle is formed at the intersection of the downward and upward slopes of the calcaneal superior surface, located beneath the lateral process of the talus. Normal range is approximately 120°-140°. An increase indicates architectural disruption of the posterior facet.

Time frame
Preoperative, immediate postoperative, and at least 12 months postoperatively
3

Change in Calcaneal Height

Change in calcaneal height measured on lateral X-rays from preoperative to postoperative and final follow-up. A decrease in calcaneal height indicates collapse of the fractured calcaneus.

Time frame
Preoperative, immediate postoperative, and at least 12 months postoperatively
4

Change in Calcaneal Width

Change in calcaneal width measured on axial X-rays from preoperative to postoperative and final follow-up. An increase in calcaneal width indicates lateral wall bulging after fracture.

Time frame
Preoperative, immediate postoperative, and at least 12 months postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: