Evaluation of the Stability of Osseointegrated Implant in Upper Limb or Lower Limb Amputees
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prosthesis Migration
- Sponsor
- Istituto Ortopedico Rizzoli
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Rotation
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Stefano Zaffagnini
Full Professor and Head of department
Istituto Ortopedico Rizzoli
Eligibility Criteria
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;
Outcomes
Primary Outcomes
Rotation
Time Frame: 24 months
Rotations X, Y, Z (in degrees) of the implant with respect to the bone
Translation
Time Frame: 24 months
Translations X, Y, Z (in mm) of the implant with respect to the bone
Secondary Outcomes
- Lower limb: Autonomy(24 months)
- Health-related quality of life(24 months)
- lower limb: Mobility(4 months)
- Pain evaluation(24 months)
- Upper limb: functionality(24 months)
- Upper Limb: Development and evaluation of the activities measure for upper limb amputees(24 months)