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

March 3, 2026 updated by: Christian Candrian

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Lugano, Switzerland, 6900
        • Ospedale Regionale di Lugano Civico e Italiano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Femoral prosthesis
newly developed prosthesis for trans-femoral amputation
Device: Medacta femoral prosthesis
patients' treatment with a new implant prosthesis

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: Two years
Post surgery adverse events collecting adverse events
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Christian Candrian

Investigators

  • Principal Investigator: Christian Candrian, Dr. med, EOC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2018

Primary Completion (Actual)

September 30, 2025

Study Completion (Actual)

September 30, 2025

Study Registration Dates

First Submitted

January 9, 2018

First Submitted That Met QC Criteria

February 20, 2018

First Posted (Actual)

February 26, 2018

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • ORL ORT 001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

not foreseen

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Trans-femoral Amputated Patients

Clinical Trials on Medacta femoral prosthesis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe