An interventional study of Minimally invasive surgical application of Calcanail® and Immobilisation by cast boot in Calcaneus ; Fracture ; Traumatology, sponsored by Centre Hospitalier Universitaire de Nice. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-16.
Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Treatment
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.
2,272 studies on the registry are indexed under Fractures, Bone; 321 are open to participants now.
This study's planned enrollment of 50 is below the median of 68 across 1,490 interventional studies indexed under Fractures, Bone.
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Procedure: Minimally invasive surgical application of Calcanail®
Procedure: Immobilisation by cast boot
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.
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.
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
Time frame: 1 year follow-up
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 year follow-up
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