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

Launched by CHRISTIAN CANDRIAN · Feb 20, 2018

Keywords

ClinConnect Summary

This clinical trial is exploring a new type of prosthesis for patients who have had a leg amputated above the knee (known as trans-femoral amputation) and are experiencing pain or discomfort with their current prosthetic devices. The goal is to see if this new prosthesis can help improve their comfort and overall quality of life. The trial is currently in the process of recruiting participants, specifically those aged between 18 and 75 who have had their amputation for at least two years and have been struggling with pain levels or quality of life issues related to their existing prosthesis.

To be eligible for this study, participants should have a baseline pain score between 3 and 10, or a lower quality of life score. They must also have undergone amputation due to either trauma or cancer. However, individuals with certain medical conditions, such as infections or specific diseases that affect the body’s ability to heal, will not be included. Participants in the trial will be able to try the new prosthesis and share their experiences regarding comfort and functionality, contributing to the understanding of how well this new device can meet the needs of trans-femoral amputees.

Gender

ALL

Eligibility criteria

• 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