Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

12 september 2026 bijgewerkt door: Zhou Fang, Peking University Third Hospital

Impact of Sustentaculum Tali Screw Fixation Mode on Radiographic and Functional Outcomes in Patients With Intra-Articular Calcaneal Fractures: An Ambidirectional Cohort Study

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Background: Calcaneal fractures account for approximately 1% to 2% of all fractures and are the most common tarsal bone fractures, usually caused by high-energy injuries such as falls from height and motor vehicle accidents. Most are intra-articular fractures involving the subtalar joint. Open reduction and internal fixation is the mainstay of treatment for displaced intra-articular calcaneal fractures, aiming to restore the congruity of the subtalar articular surface and the normal morphology of the calcaneus.

The sustentaculum tali is a bony prominence on the medial side of the calcaneus that forms the middle facet of the subtalar joint. Because of its dense bone and strong ligamentous attachments, it is a key anchor point for fracture reduction and internal fixation. During surgery via a lateral approach, a sustentaculum tali screw is inserted from the lateral wall toward the medial side to provide stable support for the reduced posterior articular surface.

Depending on the screw tip position on postoperative imaging, fixation is classified as sustentaculum tali fixation (ST; screw penetrates within the range of the sustentaculum tali) or sustentaculum tali fragment fixation (STF; screw is fixed into the larger medial fragment containing the sustentaculum tali, with the penetration point outside the sustentaculum tali range). Because the sustentaculum tali is small and irregularly shaped, accurate screw placement is technically demanding, with reported accuracy of only 60% to 80% even among experienced surgeons. Recent studies suggest that fixation into the sustentaculum fragment may achieve clinical outcomes similar to precise sustentaculum tali fixation; however, the effect of the different fixation modes on postoperative foot and ankle function remains insufficiently investigated.

Design and methods: This is an ambidirectional cohort study. Approximately 92 participants with intra-articular calcaneal fractures treated by open reduction and internal fixation will be enrolled, including retrospective cases from January 2015 to August 2026 and prospective cases from September 2026. Participants will be naturally allocated to the ST or STF group according to the fixation mode determined on postoperative lateral and axial X-rays; no randomization is performed and no treatment plan is altered by the study.

Data are collected during routine clinical follow-up at 1 week, 6 weeks, 12 weeks, 24 weeks, and 1 year after surgery; no additional examinations or interventions are required. Radiographic parameters (Böhler's angle, Gissane's angle, calcaneal height and width) are measured on pre- and postoperative X-rays, and functional outcomes are assessed with the AOFAS ankle-hindfoot score and the Maryland Foot Score at least 12 months postoperatively.

Statistical analysis: Continuous variables will be compared using the t-test or the Wilcoxon rank-sum test according to their distribution, and categorical variables will be compared using the chi-square test. Two-sided P < 0.05 will be considered statistically significant. Multivariable regression may be used to adjust for potential confounders where appropriate. Analyses will be performed with SPSS 26.0 (IBM, Armonk, NY, USA).

Studietype

Observationeel

Inschrijving (Geschat)

92

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Clinical Trial Office
  • Telefoonnummer: 010-82266699
  • E-mail: bysy@bjmu.edu.cn

Studie Locaties

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100191
        • Peking University Third Hospital
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.
Ander: Screw Tip Position Relative to the Sustentaculum Tali
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 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.
Ander: Screw Tip Position Relative to the Sustentaculum Tali
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Maryland Foot Score
Tijdsspanne: At least 12 months postoperatively
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
Tijdsspanne: At least 12 months postoperatively
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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Böhler's Angle
Tijdsspanne: Preoperative, immediate postoperative, and at least 12 months postoperatively
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.
Preoperative, immediate postoperative, and at least 12 months postoperatively
Change in Gissane's Angle
Tijdsspanne: Preoperative, immediate postoperative, and at least 12 months postoperatively
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.
Preoperative, immediate postoperative, and at least 12 months postoperatively
Change in Calcaneal Height
Tijdsspanne: Preoperative, immediate postoperative, and at least 12 months postoperatively
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.
Preoperative, immediate postoperative, and at least 12 months postoperatively
Change in Calcaneal Width
Tijdsspanne: Preoperative, immediate postoperative, and at least 12 months postoperatively
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.
Preoperative, immediate postoperative, and at least 12 months postoperatively
Postoperative Complications
Tijdsspanne: Up to 12 months postoperatively
Number of participants with postoperative complications, including wound infection, screw loosening, sural nerve injury, and other surgery-related adverse events. Complications will be recorded during routine clinical follow-up.
Up to 12 months postoperatively

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Peking University Third Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

20 september 2026

Primaire voltooiing (Geschat)

31 december 2028

Studie voltooiing (Geschat)

31 december 2028

Studieregistratiedata

Eerst ingediend

12 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

12 september 2026

Eerst geplaatst (Werkelijk)

16 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

16 september 2026

Laatste update ingediend die voldeed aan QC-criteria

12 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • PekingUTH ZF SUS Screw

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren