Early Rehabilitation After Transfemoral Amputation in Moderately Active Patients

Median Technologies

Status: Enrolling

Conditions: Transfemoral Amputation

Treatments: Other: Amputation-specialized rehabilitation; Other: Non-amputation-specialized rehabilitation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06045468

Kenevo2023

Details and patient eligibility

About

Treatment and rehabilitation after transfemoral amputation represents a challenging medical field, involving intersectoral parties. Although treatment guidelines exists, their implementation is difficult. This study is conducted to evaluate the need to practice these guidelines in order to gain best benefits for the patients. Focus is set of early inpatient rehabilitation and the role of a microprocessor-controlled prothesis (Kenevo, Ottobock).

Full description

Right after major surgeries, e.g. amputations, inpatient rehabilitation follows in Germany. Costs are covered by different insurances, like public or private health care insurances or German pension insurance. Usually, inpatient rehabilitation lasts for 3 weeks. But after some surgeries, like amputation, patients need more time to recover and fitting of a prosthesis takes additional time. Therefore guidelines state, that rehabilitation should take up to 6-8 weeks after major amputation. To provide evidence to these guidelines, we conducted this study.

Patients' choice on rehabilitation clinic decides on their assignment to the study group or control group. Inpatient rehabilitation is monitored with outcomes measurements. 3 measurements are carried out in the study group within rehabilitational stay of around 6 weeks (admission - middle - discharge) and 2 measurements are carried out in the control group within rehabilitational stay of around 3 weeks (admission - discharge). After discharge from rehabilitation, assessment of patient reported outcome measurements is continued every 6 weeks for both groups. Follow-up phase ends with 24 weeks after admission to rehabilitation.

For subanalysis, different prosthetic devices (non-microprocessor-controlled vs. microprocessor-controlled prosthesis) are compared.

Enrollment: 125 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• inpatient rehabilitation stay after transfemoral amputation or knee disarticulation
• anticipated K-level 1 or 2
• body weight no more than 125kg (authorized body weight for prosthetic device)
• German speaking
• able to give informed consent

Exclusion criteria

• non-German speaking
• not able to give informed consent
• body weight over 125kg

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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125 participants in 2 patient groups

Study group

Experimental group

Description:

Patients in inpatient rehabilitation in study center.

Treatment:

Other: Amputation-specialized rehabilitation

Control group

Experimental group

Description:

Patients in inpatient rehabilitation facility of collaborating clinics.

Treatment:

Other: Non-amputation-specialized rehabilitation