NCT03445481

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

February 20, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 26, 2018

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

7.6 years

First QC Date

January 9, 2018

Last Update Submit

March 3, 2026

Conditions

Trans-femoral Amputated Patients

Outcome Measures

Primary Outcomes (1)

  • Quality of Life

    Patients outcome evaluation of health-related quality of life through quality of life questionnaire EQ-5D-5L

    Two years

Secondary Outcomes (1)

  • Adverse Events

    Two years

Study Arms (1)

Femoral prosthesis

EXPERIMENTAL

newly developed prosthesis for trans-femoral amputation

Device: Medacta femoral prosthesis

Interventions

Medacta femoral prosthesisDEVICE

patients' treatment with a new implant prosthesis

Femoral prosthesis

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • Trauma
  • Oncologic disease
  • Written informed consent

You may not qualify if:

  • Trans-femoral amputation due to infection
  • Patients affected by
  • metabolic disease
  • neurologic degenerative disease
  • vascular disease proximal to the amputation
  • body weight \>100 kg
  • Hip arthritis of the amputated limb

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Regionale di Lugano Civico e Italiano

Lugano, 6900, Switzerland

Location

Study Officials

  • Christian Candrian, Dr. med

    EOC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 9, 2018

First Posted

February 26, 2018

Study Start

February 20, 2018

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

March 5, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

not foreseen

Locations

CH(1)