Comparing the effectiveness of different types of prosthetic knees for amputees
Comparing the Effectiveness and Cost-effectiveness of Conventional Mechanical Knees and Microprocessor-controlled Knees: a Prospective Cohort Study
This study is testing if microprocessor-controlled knees help amputees walk better and feel more active compared to regular prosthetic knees.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 28 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Center Groningen Academic / other |
| Locations | 9 sites (Breda and 8 other locations) |
| Trial ID | NCT06031922 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of microprocessor-controlled knees (MPKs) compared to non-microprocessor-controlled knees (NMPKs) in individuals with lower limb amputations in the Netherlands. Participants will undergo a series of physical tests, complete questionnaires, and wear an activity tracker over a year to assess their walking distance and overall functional performance. The study will involve a baseline measurement, a six-week trial with the MPK, and follow-up assessments to compare outcomes. The research considers various levels of the International Classification of Functioning (ICF) model to provide a comprehensive understanding of the impact of prosthetic knee types on users.
Who should consider this trial
Good fit: Ideal candidates include individuals with unilateral transfemoral amputation or knee-disarticulation who are at least one year post-amputation and eligible for a trial on an MPK.
Not a fit: Patients with bilateral amputations, those who have undergone osseointegration, or individuals with prior experience using an MPK may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prosthetic options and rehabilitation strategies for amputees, enhancing their mobility and quality of life.
How similar studies have performed: Other studies have shown promising results in comparing different prosthetic knee technologies, indicating that this approach is supported by existing literature.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * At least one year post amputation * Unilateral transfemoral amputation or knee-disarticulation * Eligible for a trial on an MPK * Able to read and write in Dutch * Use a prosthesis with a socket Exclusion Criteria: * Bilateral amputation * Osseointegration * Previous experience with an MPK
Where this trial is running
Breda and 8 other locations
- Revant medisch specialistische revalidatie — Breda, Netherlands (Recruiting)
- Revalidatiecentrum Roessingh — Enschede, Netherlands (Recruiting)
- Revant medisch specialistische revalidatie | Lindenhof — Goes, Netherlands (Recruiting)
- University Medical Center Groningen — Groningen, Netherlands (Recruiting)
- Adelante zorggroep — Hoensbroek, Netherlands (Recruiting)
- Rijndam Revalidatie — Rotterdam, Netherlands (Recruiting)
- De Hoogstraat Revalidatie — Utrecht, Netherlands (Recruiting)
- Heliomare Centrum voor Specialistische Revalidatie — Wijk aan Zee, Netherlands (Recruiting)
- Vogellanden, centrum voor medisch specialistische revalidatie, bijzondere tandheelkunde en gezonde leefstijl — Zwolle, Netherlands (Recruiting)
Study contacts
- Study coordinator: Charlotte E Bosman
- Email: c.e.bosman@umcg.nl
- Phone: +31503611348
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.