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

Trans-femoral Amputated Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03445481
• Other study ID #: ORL ORT 001
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2018
• Est. completion date: December 31, 2027

Study information

• Verified date: December 2023
• Source: Ente Ospedaliero Cantonale, Bellinzona
• Contact: Christian Candrian, Dr. med
• Phone: +41 (0) 91 811 61 23
• Email: christian.candrian[@]eoc.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Trans-femoral Amputated Patients

Intervention

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

Locations

Country	Name	City	State
Switzerland	Ospedale Regionale di Lugano Civico e Italiano	Lugano

Sponsors (1)

Lead Sponsor	Collaborator
Christian Candrian

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life	Patients outcome evaluation of health-related quality of life through quality of life questionnaire EQ-5D-5L	Two years
Secondary	Adverse Events	Post surgery adverse events collecting adverse events	Two years