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

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: Not yet recruiting
• Conditions: Calcaneus ; Fracture ; Traumatology
• Intervention / Treatment: Procedure: Minimally invasive surgical application of Calcanail®; Procedure: Immobilisation by cast boot

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tristan FAUCHILLE, Doctor; Phone Number: +33 0492037524; Email: recherche.iuls@chu-nice.fr
• Study Contact Backup: Name: Charlotte CIAIS; Phone Number: +33 0492039393; Email: ciais.c3@chu-nice.fr

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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.	The primary endpoint is the American Orthopaedic Foot & Ankle Society (AOFAS) clinical score	1 year follow-up

Secondary Outcome Measures

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)	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)	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)	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.	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.	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.	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

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Estimated): January 16, 2025
• Primary Completion (Estimated): January 16, 2028
• Study Completion (Estimated): January 16, 2028

Study Registration Dates

• First Submitted: January 10, 2025
• First Submitted That Met QC Criteria: January 15, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 15, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID 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