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

Not Applicable

Recruiting

• Conditions: Trans-femoral Amputated Patients
• Interventions: Device: Medacta femoral prosthesis

• Registration Number: NCT03445481
• Lead Sponsor: Christian Candrian

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.

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.

Study Timeline

• Study First Submitted: 2018-01-09
• Study Start: 2018-02-20
• Study First Submitted QC: 2018-02-20
• Study First Posted: 2018-02-26
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-16
• Last Update Posted: 2024-07-17
• Primary Completion: 2025-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Femoral prosthesis	Medacta femoral prosthesis	newly developed prosthesis for trans-femoral amputation

Primary Outcome Measures

Name	Time	Method
Quality of Life	Two years	Patients outcome evaluation of health-related quality of life through quality of life questionnaire EQ-5D-5L

Secondary Outcome Measures

Name	Time	Method
Adverse Events	Two years	Post surgery adverse events collecting adverse events

Trial Locations

Locations (1)

Ospedale Regionale di Lugano Civico e Italiano; 🇨🇭 Lugano, Switzerland