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

NCT ID: NCT06779305

Last Updated: 2025-01-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-16
• Study Completion Date: 2028-01-16

Brief Summary

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.

Conditions

Calcaneus ; Fracture ; Traumatology

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Minimally invasive surgery group

Group Type: EXPERIMENTAL

Minimally invasive surgical application of Calcanail®

Intervention Type: PROCEDURE

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.

Conservative treatment group

Group Type: ACTIVE_COMPARATOR

Immobilisation by cast boot

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Tristan FAUCHILLE, Doctor

Role: CONTACT

recherche.iuls@chu-nice.fr

0492037524 ext. +33

Charlotte CIAIS

Role: CONTACT

ciais.c3@chu-nice.fr

0492039393 ext. +33

Other Identifiers

24-PP-14

Identifier Type: -

Identifier Source: org_study_id