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

Christian Candrian

Status: Enrolling

Conditions: Trans-femoral Amputated Patients

Treatments: Device: Medacta femoral prosthesis

Study type: Interventional

Funder types: Other

Identifiers

NCT03445481

ORL ORT 001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Femoral prosthesis

Experimental group

Description:

newly developed prosthesis for trans-femoral amputation

Treatment:

Device: Medacta femoral prosthesis