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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
4
Evaluation of stability of implant by RSA technique
Istituto Ortopedico Rizzoli
Bologna, Italy
Rotation
Rotations X, Y, Z (in degrees) of the implant with respect to the bone
Time frame: 24 months
Translation
Translations X, Y, Z (in mm) of the implant with respect to the bone
Time frame: 24 months
Health-related quality of life
36-Item Short Form Survey (SF36 )
Time frame: 24 months
Pain evaluation
Visual Analog Scale (VAS)
Time frame: 24 months
Lower limb: Autonomy
Barthel Index
Time frame: 24 months
lower limb: Mobility
Rivermead Mobility Index
Time frame: 4 months
Upper limb: functionality
The Disabilities of the Arm, Shoulder and Hand (DASH)
Time frame: 24 months
Upper Limb: Development and evaluation of the activities measure for upper limb amputees
Activities Measure for Upper Limb Amputees (AM-ULA)
Time frame: 24 months
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