Minimally Invasive Procedure Versus Conservative Treatment in the Management of Calcaneal Joint Fractures (IMPACT)

January 15, 2025 updated by: Centre Hospitalier Universitaire de Nice
Calcaneal fractures, which affect the heel bone, are the most common type of tarsal fractures and often occur in young people, leading to long recovery times and significant social and economic consequences. Traditional treatments include either non-surgical methods, like immobilizing the foot in a cast, or open surgery, which involves a large incision to fix the bone with plates. However, open surgery has a high complication rate, including issues with wound healing. Recent advances have introduced minimally invasive surgical techniques, which use smaller incisions and have shown better results with fewer complications. This study aims to compare two treatment options for displaced calcaneal fractures: a minimally invasive surgery group and a non-surgical treatment group using a plaster boot. The goal is to determine whether minimally invasive surgery provides better outcomes for patients, such as faster recovery, fewer complications, and improved long-term function, to guide future treatment practices. Thus, this is a prospective, randomised comparative study of the management of articular fractures of the calcaneus: conservative treatment versus minimally invasive surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patient aged 18 or over
  2. Patient with a posterior articular fracture of the calcaneus Sanders II to IV, less than 15 days old
  3. Patient affiliated to a social security scheme,
  4. Patient having given written consent following written and oral information.

Exclusion Criteria:

  1. Patient with open calcaneal fracture
  2. Patient with bilateral calcaneal fracture
  3. Patient with extreme varus or valgus impingement of the fibula
  4. Patient with associated talar, tibial, femoral and/or pelvic fracture or associated spinal cord injury.
  5. Patient unsuitable for loco-regional anaesthesia (LRA).
  6. Patient with neuro-psychiatric disorders resulting in an inability to follow a post-surgical or post-immobilisation rehabilitation protocol.
  7. Pregnant women
  8. Patient protected by law under guardianship or curatorship, or unable to participate in a clinical study under article L. 1121-16 of the French Public Health Code.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Minimally invasive surgery group
Procedure: Minimally invasive surgical application of Calcanail®
The procedure involves making small incisions to insert a specialized nail into the bone to realign and stabilize the fracture. This approach minimizes damage to surrounding tissues, reduces the risk of wound complications, and allows for quicker recovery compared to traditional open surgery. after surgery, the patient will benefit from an immobilisation with a plaster boot without support for 3 weeks, followed by immobilisation with a removable walking boot for 3 weeks with partial support depending on the patient's pain.
Active Comparator: Conservative treatment group
Procedure: Immobilisation by cast boot
The patient will be immobilised in a plaster cast without support for 3 weeks, followed by immobilisation in a removable walking boot for 3 weeks with partial support depending on the pain.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To show a significant difference in favour of minimally invasive surgical treatment compared with orthopaedic treatment for displaced articular fractures of the calcaneus.
Time Frame: 1 year follow-up
The primary endpoint is the American Orthopaedic Foot & Ankle Society (AOFAS) clinical score
1 year follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Demonstrate the superiority of minimally invasive surgical treatment over orthopaedic treatment on :A reduction in the rate of early complications (skin problems, infections, complex regional pain syndrome)
Time Frame: 1 year follow-up
The superiority of minimally invasive surgery over orthopaedic surgery in terms of early complications will be assessed by the rate of scar disunions, skin necrosis, complex regional pain syndrome (CRPS) and surgical site infections.
1 year follow-up
Demonstrate the superiority of minimally invasive surgical treatment over orthopaedic treatment on :A reduction in the rate of late complications (rate of arthrodesis revision)
Time Frame: 1 year follow-up
Assessment of the superiority of minimally invasive surgical treatment over orthopaedic treatment in terms of late complications will be based on the long-term need for revision surgery or subtalar arthrodesis.
1 year follow-up
Demonstrate the superiority of minimally invasive surgical treatment over orthopaedic treatment on :Improved anatomical relationships (radiological measurements)
Time Frame: 1 year follow-up
Assessment of the superiority of minimally invasive surgical treatment over orthopaedic treatment in terms of restoration of calcaneal anatomy will be based on radiological measurements: Bohler angle and Meary angle. The Böhler angle is expressed in degrees and correlates with the recovery or otherwise of the calcaneal morphology. The Meary angle is expressed in degrees and correlates with the recovery or otherwise of the axis of the hindfoot.
1 year follow-up
Demonstrate the superiority of minimally invasive surgical treatment over orthopaedic treatment on : Improved bootability at 1 year.
Time Frame: 1 year follow-up
Assessment of the superiority of minimally invasive surgical treatment over orthopaedic treatment with respect to footwear will be assessed by being able to fit into: a) all types of footwear, b) some or c) not being able to fit into footwear.
1 year follow-up
Demonstrate the superiority of minimally invasive surgical treatment over orthopaedic treatment on :A reduction in the time taken to return to work and sport at 1 year.
Time Frame: 1 year follow-up
Assessment of the superiority of minimally invasive surgical treatment compared to orthopaedic treatment in terms of whether or not the patient can return to work and sport (binary yes or no answer) at follow-up consultations.
1 year follow-up
Demonstrate the superiority of minimally invasive surgical treatment over orthopaedic treatment on : An improvement in the patient self-assessment score (SAV) at 1 year.
Time Frame: 1 year follow-up
Assessment of the superiority of minimally invasive surgical treatment compared to orthopaedic treatment in terms of patient self-evaluation score. This will be based on the SAV Simple Ankle Value (PROMS) score (Appendix II). The assessment question will be "What percentage would you rate the function of your ankle today, if 100% was a normal ankle?". The answer will be on a scale from 0% to 100%, where 100% is normal function.
1 year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 16, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 16, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 16, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 24-PP-14

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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