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

Overview

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.

Full Title of Study: “Pilot Study of New Prosthesis for Trans-femoral Amputated Patients Clinical Study Protocol”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2025

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.

Interventions

  • Device: Medacta femoral prosthesis
    • patients’ treatment with a new implant prosthesis

Arms, Groups and Cohorts

  • Experimental: Femoral prosthesis
    • newly developed prosthesis for trans-femoral amputation

Clinical Trial Outcome Measures

Primary Measures

  • Quality of Life
    • Time Frame: Two years
    • Patients outcome evaluation of health-related quality of life through quality of life questionnaire EQ-5D-5L

Secondary Measures

  • Adverse Events
    • Time Frame: Two years
    • Post surgery adverse events collecting adverse events

Participating in This Clinical Trial

Inclusion Criteria

  • Age >18 and <75 years – Patients with Trans-femoral Amputations since at least 2 years and suffering from pain and discomfort with the current standard socket prosthesis, i.e., with a baseline VAS score for pain between 3 and 10 or a health-related quality of life (Eq-5D) score < 60 or an SF-36 result below the 50th percentile – Amputation due to: 1. Trauma 2. Oncologic disease – Written informed consent Exclusion Criteria:

  • Trans-femoral amputation due to infection – Patients affected by 1. metabolic disease 2. neurologic degenerative disease 3. vascular disease proximal to the amputation 4. body weight >100 kg 5. Hip arthritis of the amputated limb

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Christian Candrian
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Christian Candrian, MD – Ente Ospedaliero Cantonale, Bellinzona
  • Overall Official(s)
    • Christian Candrian, Dr. med, Principal Investigator, EOC
  • Overall Contact(s)
    • Christian Candrian, Dr. med, +41 (0) 91 811 61 23, christian.candrian@eoc.ch

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