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
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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.
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.
Christian Candrian is the lead sponsor of 7 studies on the registry; 4 are open to participants now.
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Amputation due to:
Exclusion Criteria:
Patients affected by
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
newly developed prosthesis for trans-femoral amputation
Device: Medacta femoral prosthesis
patients' treatment with a new implant prosthesis
Quality of Life
Patients outcome evaluation of health-related quality of life through quality of life questionnaire EQ-5D-5L
Time frame: Two years
Adverse Events
Post surgery adverse events collecting adverse events
Time frame: Two years
Plan to share: No — not foreseen
No publications or documents are linked to this record.
Ran from Feb 2018 to primary completion in Sep 2025, 91 months.
How these figures are worked out, and which studies are left out of them.
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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Christian Candrian