NCT03445481

Clinical Pilot Study of New Prosthesis for Trans-femoral Amputated Patients

Pilot Study of New Prosthesis for Trans-femoral Amputated Patients Clinical Study Protocol

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Christian Candrian · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Patients with a trans-femoral amputation who experienced problems, complications pain due to the ischial weight bearing and discomfort with conventional socket prosthesis will be proposed to implant a new developed prosthesis.

Detailed description

The patients will undergo a surgical operation to implant a femoral prosthesis according to the hospital's protocol. The surgical intervention will be performed under general or spinal anesthesia with a tourniquet at the root of the lower limb. Under sterile conditions, the incision of the stump will be done at the level of the previous surgical scar. Preserving the soft tissue, the distal femoral bone is reached. Then, the medullary canal is opened and prepared with reamers of increasing diameter. A femoral cemented stem of appropriate dimensions correlated to the size of the canal and 105 mm of height is implanted. To the above-mentioned stem, the Medacta prosthesis will be fixed with a blocking screw. The prosthesis is then covered with the soft tissue and layered suturing of the stump is performed.

Conditions

• Trans-femoral Amputated Patients

Interventions

Type	Name	Description
DEVICE	Medacta femoral prosthesis	patients' treatment with a new implant prosthesis

Timeline

• Start date: 2018-02-20
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2018-02-26
• Last updated: 2026-03-05

Locations

1 site across 1 country: Switzerland