NCT04276714

Revofit™ System Evaluation on Residual Limb Pain in Amputee Patients

Revofit™ System and Residual Limb Pain in Amputee Patients : Multiple N-of-1 Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University Hospital, Angers · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

At the early stage of the amputation, the residual limb presents post-surgical fluctuations related to post-operative phase, which would need a frequent prosthetic adjustment. In most cases, the volume of residual limb is constant from 12 to 18 months after surgery. However, some daily fluctuations could appear due to an underlying vascular disease for example, which could be painful and impact the quality of life with a constant need of prosthetics adjustment. The goal of this study is to assess the effectiveness of a system-adjusted fitting in comparison with a standard fitting.

Detailed description

With the " multiple N-of-1 trial " study type, pain, quality of life, functional effects and the patient satisfaction with assistive technology will be assessed for four weeks.

Conditions

• Amputation
• Adult Disease

Interventions

Type	Name	Description
OTHER	Socket without Revofit system	All the tests are evaluate during one week with the classical type of fittings
OTHER	Socket with Revofit system	All the tests are evaluate during one week with the adjustable type of fittings (that is to say with Revofit system)

Timeline

• Start date: 2021-02-22
• Primary completion: 2021-03-10
• Completion: 2021-03-10
• First posted: 2020-02-19
• Last updated: 2022-07-06

Locations

1 site across 1 country: France