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

NCT07822698 | Not Yet Recruiting

• 1 other identifier: PekingUTH ZF SUS Screw
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Calcaneal Fractures

Keywords

Calcaneal Fracture; Sustentaculum Tali Screw

Outcome Measures

Primary Outcomes (2)

• 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.

  At least 12 months postoperatively

• 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.

  At least 12 months postoperatively

Secondary Outcomes (5)

• Change in Böhler's Angle

  Preoperative, immediate postoperative, and at least 12 months postoperatively

• Change in Gissane's Angle

  Preoperative, immediate postoperative, and at least 12 months postoperatively

• Change in Calcaneal Height

  Preoperative, immediate postoperative, and at least 12 months postoperatively

• Change in Calcaneal Width

  Preoperative, immediate postoperative, and at least 12 months postoperatively

• Postoperative Complications

  Up to 12 months postoperatively

Study Arms (2)

Sustentaculum Tali (ST) Fixation

Participants with intra-articular calcaneal fractures treated with open reduction and internal fixation. The exposure of interest is screw tip position: the sustentaculum tali screw penetrates within the range of the sustentaculum tali on postoperative lateral and axial X-rays. No treatment was assigned by the study; all participants received routine clinical care.

Other: Screw Tip Position Relative to the Sustentaculum Tali

Sustentaculum Tali Fragment (STF) Fixation

Participants with intra-articular calcaneal fractures treated with open reduction and internal fixation. The exposure of interest is screw tip position: the screw is fixed into the larger medial fragment containing the sustentaculum tali, with the penetration point outside the sustentaculum tali range on postoperative lateral and axial X-rays. No treatment was assigned by the study; all participants received routine clinical care.

Other: Screw Tip Position Relative to the Sustentaculum Tali

Interventions

Screw Tip Position Relative to the Sustentaculum Tali OTHER

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.

Sustentaculum Tali (ST) Fixation; Sustentaculum Tali Fragment (STF) Fixation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• \- Adults aged ≥ 18 years.
• Diagnosis of intra-articular calcaneal fracture.
• Treated with open reduction and internal fixation (ORIF).
• Availability of postoperative lateral and axial X-rays for assessment of screw tip position.
• Complete medical records for retrospective data collection, or willingness to participate in prospective follow-up.
• Written informed consent for prospective participants; informed consent waived for retrospective participants as approved by the ethics committee.

You may not qualify if:

• \- Pathological fractures.
• Open calcaneal fractures.
• Previous surgery on the affected calcaneus.
• Severe medical conditions that may affect follow-up or functional assessment.
• Inability to complete follow-up or functional questionnaires.
• Lack of adequate imaging or medical records for group allocation.
• Patients who declined to participate (for prospective cases).

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Central Study Contacts

Clinical Trial Office

CONTACT

010-82266699; bysy@bjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 12, 2026
• First Posted: September 16, 2026
• Study Start: September 20, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)