Intraosseous Transcutaneous Amputation Prosthesis

Study Overview
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Brief Summary
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Direct Skeletal Fixation of Prosthetic Limbs Following Trans-Femoral Amputation - Study of an Intraosseous Transcutaneous Amputation Prosthesis (ITAPTM).

Detailed Description
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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.

Official Title
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Direct Skeletal Fixation of Prosthetic Limbs Following Trans- Femoral Amputation - Study of an Intraosseous Transcutaneous Amputation Prosthesis (ITAP)

Conditions
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Traumatic Amputation of Lower Extremity

Intervention / Treatment
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* Device: Direct skeletal fixation of ITAP to lower limb amputees.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Trans-femoral amputation 6 months or more attempted prosthetic rehabilitation (use of walking aids not relevant) Between the ages of 18 to 60 inclusive Length of stump: Sufficient bony stock for bony integration (at the investigator's discretion) and sufficient clearance (at the investigator's discretion) from medial joint line to accommodate failsafe device/ adaptor and knee mechanism Suitable soft tissues to perform the operative procedure Flexion Deformity (FFD) at hip no more than 15° Normal range of flexion and adduction other than FFD Oxford Grade 4 muscle power in all groups around hip Normal contralateral leg function Psychologically suitable (as deemed by screening process) Sufficient standard of English to understand the Patient Information Sheet and general study requirements Ability to understand and comply with study requirements - notably study timelines and additional clinic visits Patients willing to take part in the study and sign the Informed Consent form Exclusion Criteria: Radiotherapy to target limb at any time Chemotherapy within the preceding 12 months Cognitive impairment likely to affect participation Pre-existing ipsilateral hip pathology Limited cardiorespiratory reserve / inability to walk at normal pace Any significant co-morbidity that, in the investigator's opinion, is likely to affect outcome (e.g. osteoporosis, heart disease, peripheral vascular disease, obesity or unrelated cancer) Any co-morbidity in the contra-lateral leg that precludes walking Any significant previous infection within the previous 12 months, such as apical stump sepsis or dental sepsis MRSA Using another silver-dosed medical device/treatment Patients with hypersensitivity to silver Concurrent medico-legal proceedings taking place Patients currently included in other clinical trials

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fixation of ITAP to lower limb amputees.<br>Direct skeletal fixation of ITAP to lower limb amputees. 20 patients in the study will be fitted with Intraosseous Transcutaneous Amputation Prosthesis. The device has been designed to be surgically implanted in a one stage procedure. | Device: Direct skeletal fixation of ITAP to lower limb amputees.<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adhesion check in the skin surrounding the ITAP | Skin reaction assessment reviews the adhesion to the Implant at surface layer | 12 month post surgery | 
| Assessment of skin colour surrounding the ITAP | Skin reaction assessment reviews the skin colour | 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 | 12 month post surgery | 
| Condition of the skin surrounding the ITAP | Skin reaction assessment reviews the presence of exudate | 12 month post surgery | 
| Pain at the end of stump | Skin reaction assessment reviews the pain in the skin area surrounding the ITAP | 12 month post surgery | 
| Swelling of the skin around the ITAP | Skin reaction assessment reviews the swelling around the ITAP | 12 month post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic assessment to measure osseointegration | Radiographic assessments to measure osseointegration | 18 month post surgery | 
| Radiographic assessments to measure fixation of the ITAP | Radiographic assessments to measure fixation of the ITAP | 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. | 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) | 18 month post surgery | 
| Calculate SIGAM to measure Limb specific mobility | Limb specific measure of mobility through the SIGAM mobility grades | 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) | 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 | 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. | 18 month post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osseointegration, Direct skeletal attachment