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TerminatedNCT03445481Updated Mar 5, 2026

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

An interventional study of Medacta femoral prosthesis in Trans-femoral Amputated Patients, sponsored by Christian Candrian. Terminated at 1 site in Switzerland. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-03-05.

Sponsored by Christian Candrian · Not applicable, Interventional, and Treatment

Why this study was terminated
insufficient recruitment
Phase
Not applicable
Study type
Interventional
Enrollment
3
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Trans-femoral Amputated Patients
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • Experimental
    Femoral prosthesis

    newly developed prosthesis for trans-femoral amputation

    Device: Medacta femoral prosthesis

Interventions

  • DeviceMedacta femoral prosthesis

    patients' treatment with a new implant prosthesis

05

What researchers measure

Primary outcomes

  1. Quality of Life

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

    Time frame: Two years

Secondary outcomes

  1. Adverse Events

    Post surgery adverse events collecting adverse events

    Time frame: Two years

06

Study locations

1 site
  • Ospedale Regionale di Lugano Civico e Italiano
    Lugano, 6900, Switzerland
07

References and documents

Individual participant data

Plan to share: No — not foreseen

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03445481
Lead sponsor
Christian Candrian
Responsible party
Christian Candrian (MD, Ente Ospedaliero Cantonale, Bellinzona) — Sponsor-investigator
First posted
Feb 26, 2018
Start date
Feb 20, 2018
Primary completion
Sep 30, 2025
Completion
Sep 30, 2025
Last update
Mar 5, 2026

Study contacts

Christian Candrian, Dr. med
principal investigator · EOC

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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