Amputation, Prosthesis Migration
Conditions
Keywords
osseointegration, implant migration, amputee
Brief summary
The study concerns the technique of osseointegration that consists of inserting a titanium pin into the bone of the amputated limb. A removable external prosthesis will then be connected to the implant section that protrudes from the soft parts. The benefits of using an osseointegrated prosthesis are the improved sensory feedback (osseoperception) and absence of the socket. This leads to better anchoring of the prosthesis to the abutment, greater control of the prosthesis and the absence of heat, pain, and pressure sores. The osseointegrated prosthesis does not reduce the mobility of the limb and promotes good growth of bone and muscle mass. The aim of this study is to evaluate the stability of the osseointegrated implant in trans-femoral and trans-humeral amputees. The main outcome: quantitative evaluation (rotations, translation and MTPM) of the stability of the implant bone interface by Roentgen Stereo-photogrammetric Analysis (RSA) and follow-up. The secondary outcome: evaluation of the quality of life improvement in patients through clinical score and satisfaction survey.
Interventions
DIAGNOSTIC_TESTMetacos
Evaluation of stability of implant by RSA technique
Sponsors
University of Bologna
Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
Scuola Universitaria Superiore Sant'Anna Pisa
Istituto Ortopedico Rizzoli
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* BMI\<35 kg/m2 * Problem in using socket
Exclusion criteria
* Diabetes; * Peripheral vascular diseases; * Psychiatric problems; * Pregnancy; * Rheumatoid arthritis; * Neurovascular diseases; * Neurological deficits; * Amputation of the contralateral limb; * Infections in progress; * Immunosuppression;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rotation | 24 months | Rotations X, Y, Z (in degrees) of the implant with respect to the bone |
| Translation | 24 months | Translations X, Y, Z (in mm) of the implant with respect to the bone |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lower limb: Autonomy | 24 months | Barthel Index |
| lower limb: Mobility | 4 months | Rivermead Mobility Index |
| Health-related quality of life | 24 months | 36-Item Short Form Survey (SF36 ) |
| Upper Limb: Development and evaluation of the activities measure for upper limb amputees | 24 months | Activities Measure for Upper Limb Amputees (AM-ULA) |
| Upper limb: functionality | 24 months | The Disabilities of the Arm, Shoulder and Hand (DASH) |
| Pain evaluation | 24 months | Visual Analog Scale (VAS) |
Countries
Italy
Outcome results
None listed