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| Name | Class |
|---|---|
| University of Bologna | OTHER |
| Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro | OTHER |
| Scuola Universitaria Superiore Sant'Anna Pisa | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| METACOS | Other | Required to do some motor tasks during static and dynamic RSA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metacos | Diagnostic Test | Evaluation of stability of implant by RSA technique |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rotation | Rotations X, Y, Z (in degrees) of the implant with respect to the bone | 24 months |
| Translation | Translations X, Y, Z (in mm) of the implant with respect to the bone | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Health-related quality of life | 36-Item Short Form Survey (SF36 ) | 24 months |
| Pain evaluation | Visual Analog Scale (VAS) | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Ortopedico Rizzoli | Bologna | 40136 | Italy |
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| ID | Term |
|---|---|
| D011475 | Prosthesis Failure |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Lower limb: Autonomy | Barthel Index | 24 months |
| lower limb: Mobility | Rivermead Mobility Index | 4 months |
| Upper limb: functionality | The Disabilities of the Arm, Shoulder and Hand (DASH) | 24 months |
| Upper Limb: Development and evaluation of the activities measure for upper limb amputees | Activities Measure for Upper Limb Amputees (AM-ULA) | 24 months |