Intraosseous Transcutaneous Amputation Prosthesis

Traumatic Amputation of Lower Extremity Clinical Trial

— (ITAP)  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02491424
• Other study ID #: 06-01
• Status: Completed
• Phase: N/A
• Start date: January 2007
• Est. completion date: January 2016

Study information

• Verified date: April 2016
• Source: Stryker Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Amputation, Traumatic
• Leg Injuries
• Traumatic Amputation of Lower Extremity

Intervention

Device:
• Direct skeletal fixation of ITAP to lower limb amputees.
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.

Locations

Country	Name	City	State
United Kingdom	Royal Orthopaedic	Birmingham
United Kingdom	Royal National Orthopaedic Hospital	Stanmore

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Orthopaedics

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adhesion check in the skin surrounding the ITAP	Skin reaction assessment reviews the adhesion to the Implant at surface layer	12 month post surgery
Primary	Assessment of skin colour surrounding the ITAP	Skin reaction assessment reviews the skin colour	12 month post surgery
Primary	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
Primary	Condition of the skin surrounding the ITAP	Skin reaction assessment reviews the presence of exudate	12 month post surgery
Primary	Pain at the end of stump	Skin reaction assessment reviews the pain in the skin area surrounding the ITAP	12 month post surgery
Primary	Swelling of the skin around the ITAP	Skin reaction assessment reviews the swelling around the ITAP	12 month post surgery
Secondary	Radiographic assessment to measure osseointegration	Radiographic assessments to measure osseointegration	18 month post surgery
Secondary	Radiographic assessments to measure fixation of the ITAP	Radiographic assessments to measure fixation of the ITAP	18 month post surgery
Secondary	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
Secondary	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
Secondary	Calculate SIGAM to measure Limb specific mobility	Limb specific measure of mobility through the SIGAM mobility grades	18 month post surgery
Secondary	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
Secondary	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
Secondary	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