New prosthesis for patients with trans-femoral amputations
Pilot Study of New Prosthesis for Trans-femoral Amputated Patients Clinical Study Protocol
This study is testing a new type of leg prosthesis for people with above-the-knee amputations to see if it can reduce pain and improve comfort compared to regular prosthetics.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Ente Ospedaliero Cantonale, Bellinzona Academic / other |
| Locations | 1 site (Lugano) |
| Trial ID | NCT03445481 on ClinicalTrials.gov |
What this trial studies
This clinical pilot study aims to evaluate a newly developed femoral prosthesis for patients who have undergone trans-femoral amputation and are experiencing pain and discomfort with conventional socket prostheses. Participants will undergo a surgical procedure to implant the Medacta prosthesis, which involves preparing the femoral bone and securing the prosthesis with a blocking screw. The study will assess the effectiveness of this new prosthesis in improving patient comfort and quality of life compared to existing options.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with trans-femoral amputations lasting at least two years who suffer from pain and discomfort with their current prosthesis.
Not a fit: Patients with trans-femoral amputations due to infection or those with certain medical conditions such as metabolic diseases or hip arthritis may not benefit from this study.
Why it matters
Potential benefit: If successful, this new prosthesis could significantly reduce pain and improve the quality of life for trans-femoral amputees.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving prosthetic outcomes for amputees.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lugano
- Ospedale Regionale di Lugano Civico e Italiano — Lugano, Switzerland (Recruiting)
Study contacts
- Principal investigator: Christian Candrian, Dr. med — Eoc
- Study coordinator: Christian Candrian, Dr. med
- Email: christian.candrian@eoc.ch
- Phone: +41 (0) 91 811 61 23
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.