Direct Skeletal Fixation of Prosthetic Limbs Following Trans-Femoral Amputation - Study of an Intraosseous Transcutaneous Amputation Prosthesis (ITAPTM).
The core ITAP™ design comprises of three discrete sections, the proximal section, which is the intramedullary stem secured into the medullary canal, the soft tissue integration flange and the transcutaneous component that passes through the skin. The device has been designed to be surgically implanted in a one stage procedure. In greater detail: Intra-medullary stem - this component is designed to match the natural shape of the canal and is designed using the same principles established and used for the fixation of massive endo-prosthetic replacements. In certain cases a hydroxyapatite ceramic (CaPO4) coating is used, providing enhanced uncemented fixation. In other cases, depending on the geometry of the intramedullary canal, the stem can be fixed in place using acrylic bone cement.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Intraosseous Transcutaneous Amputation Prosthesis (ITAPTM) fitting. The core ITAP™ design comprises of three discrete sections, the proximal section, which is the intramedullary stem secured into the medullary canal, the soft tissue integration flange and the transcutaneous component that passes through the skin.
Royal Orthopaedic
Birmingham, United Kingdom
Royal National Orthopaedic Hospital
Stanmore, United Kingdom
Adhesion check in the skin surrounding the ITAP
Skin reaction assessment reviews the adhesion to the Implant at surface layer
Time frame: 12 month post surgery
Assessment of skin colour surrounding the ITAP
Skin reaction assessment reviews the skin colour
Time frame: 12 month post surgery
Measuring temperature of the skin surrounding the ITAP
Skin reaction assessment reviews the temperature of the skin surrounding the ITAP and compares it to the other leg
Time frame: 12 month post surgery
Condition of the skin surrounding the ITAP
Skin reaction assessment reviews the presence of exudate
Time frame: 12 month post surgery
Pain at the end of stump
Skin reaction assessment reviews the pain in the skin area surrounding the ITAP
Time frame: 12 month post surgery
Swelling of the skin around the ITAP
Skin reaction assessment reviews the swelling around the ITAP
Time frame: 12 month post surgery
Radiographic assessment to measure osseointegration
Radiographic assessments to measure osseointegration
Time frame: 18 month post surgery
Radiographic assessments to measure fixation of the ITAP
Radiographic assessments to measure fixation of the ITAP
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Time frame: 18 month post surgery
Microbiological assessment of the stump by standard microbiological screen.
Microbiological assessment of the stump by standard microbiological screen. Data will only be recorded in the CRF in the event of an infection.
Time frame: 18 month post surgery
Calculate QTFA to measure quality of life
General quality of life through Q-TFA ( Questionnaire for persons with a transfemoral amputation)
Time frame: 18 month post surgery
Calculate SIGAM to measure Limb specific mobility
Limb specific measure of mobility through the SIGAM mobility grades
Time frame: 18 month post surgery
Gait analysis at 18 months to measure mobility
Gait analysis in patients where appropriate and possible (this data will not be collected in the CRF)
Time frame: 18 month post surgery
Subjective Qualitative Interview at 18 months to assess patient outcome
A voluntary short one hour interview at the end of the study to discuss practical and emotional aspects of the process
Time frame: 18 month post surgery
Assessment of adverse events throughout the clinical trial
Device-related and procedure-related complications will be analysed to assess device safety.
Time frame: 18 month post surgery