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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-20

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Trans-femoral Amputated Patients

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Femoral prosthesis

newly developed prosthesis for trans-femoral amputation

Group Type EXPERIMENTAL

Medacta femoral prosthesis

Intervention Type DEVICE

patients' treatment with a new implant prosthesis

Interventions

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Medacta femoral prosthesis

patients' treatment with a new implant prosthesis

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No