Comparative Study of Fixation or Fusion of Calcaneal Fractures

A Prospective Randomized Multicentre Clinical Trial Comparing Open Reduction Internal Fixation With Primary Subtalar Fusion in Patients With Severely Comminuted (Sanders IV), Displaced, Intra-articular Fractures of the Calcaneus

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00679393

Acronym

Sanders IV

Enrollment

Registered

2008-05-16

Start date

2004-02-29

Completion date

2014-12-31

Last updated

2015-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fractures, Comminuted, Fracture Fixation, Internal

Keywords

Calcaneus, Intra-articular fracture, open reduction internal fixation, primary subtalar fusion

Brief summary

A multicentre randomized controlled trial that will be conducted at Level 1 trauma centres across Canada. It will compare patients who receive open reduction, internal fixation for Sanders IV calcaneal fractures to patients who receive primary subtalar fusion for the same type of fracture. Patients will be followed up for a period of two years from the time of operation with evaluations being performed at 5 time points: 6 weeks, 3 months, 6 months, 12 months, and 24 months.

Interventions

PROCEDUREOpen reduction internal fixation

Open reduction internal fixation surgery of severely comminuted calcaneal fracture (Sanders IV).

PROCEDUREFusion

Primary subtalar fusion of severely comminuted calcaneal fracture (Sanders IV)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 59 Years

Healthy volunteers

Inclusion criteria

* patients with Sanders IV displaced intra-articular calcaneal fracture * males and females aged 16-59 inclusive * ability to provide informed consent * available for follow-up for at least 2 years after injury

Exclusion criteria

* medical contraindications to surgery * previous calcaneal pathology (infection, tumor, etc) * co-existent foot or ipsilateral lower limb injury * open calcaneal fracture * injury greater than 3 weeks old * head injured patients * inability to obtain pre-operative CT scan or accurately classify the fractures according to the Sanders classification system * inability to comply with advice to diminish smoking after the injury * metal allergy * extremely comminuted intra-articular fractures of the calcaneus deemed impossible to reconstruct by the treating surgeon * any concerns either by the treating surgeon or patient about harvesting autograft needed for fusion

Design outcomes

Primary

Measure	Time frame
General Health Survey - SF-36	6 months, 12 months, and 24 months

Secondary

Measure	Time frame
Validated Visual Analogue Scale	6 months, 12 months, and 24 months
Musculoskeletal Function Assessment	6 months, 12 months, and 24 months

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026