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

Centre Hospitalier Universitaire de Nice

Status: Not yet enrolling

Conditions: Calcaneus ; Fracture ; Traumatology

Treatments: Procedure: Immobilisation by cast boot; Procedure: Minimally invasive surgical application of Calcanail®

Study type: Interventional

Funder types: Other

Identifiers

NCT06779305

24-PP-14

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Minimally invasive surgery group

Experimental group

Treatment:

Procedure: Minimally invasive surgical application of Calcanail®

Conservative treatment group

Active Comparator group

Treatment:

Procedure: Immobilisation by cast boot