Back to resultsIntraosseous Transcutaneous Amputation Prosthesis ((ITAP))
Primary Purpose
Traumatic Amputation of Lower Extremity
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Direct skeletal fixation of ITAP to lower limb amputees.
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Amputation of Lower Extremity focused on measuring Osseointegration, Direct skeletal attachment
Eligibility Criteria
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
Sites / Locations
- Royal Orthopaedic
- Royal National Orthopaedic Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fixation of ITAP to lower limb amputees.
Arm Description
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.
Outcomes
Primary Outcome Measures
Adhesion check in the skin surrounding the ITAP
Skin reaction assessment reviews the adhesion to the Implant at surface layer
Assessment of skin colour surrounding the ITAP
Skin reaction assessment reviews the skin colour
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
Condition of the skin surrounding the ITAP
Skin reaction assessment reviews the presence of exudate
Pain at the end of stump
Skin reaction assessment reviews the pain in the skin area surrounding the ITAP
Swelling of the skin around the ITAP
Skin reaction assessment reviews the swelling around the ITAP
Secondary Outcome Measures
Radiographic assessment to measure osseointegration
Radiographic assessments to measure osseointegration
Radiographic assessments to measure fixation of the ITAP
Radiographic assessments to measure fixation of the ITAP
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.
Calculate QTFA to measure quality of life
General quality of life through Q-TFA ( Questionnaire for persons with a transfemoral amputation)
Calculate SIGAM to measure Limb specific mobility
Limb specific measure of mobility through the SIGAM mobility grades
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)
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
Assessment of adverse events throughout the clinical trial
Device-related and procedure-related complications will be analysed to assess device safety.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02491424
Brief Title
Intraosseous Transcutaneous Amputation Prosthesis
Acronym
(ITAP)
Official Title
Direct Skeletal Fixation of Prosthetic Limbs Following Trans- Femoral Amputation - Study of an Intraosseous Transcutaneous Amputation Prosthesis (ITAP)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stryker Orthopaedics
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Direct Skeletal Fixation of Prosthetic Limbs Following Trans-Femoral Amputation - Study of an Intraosseous Transcutaneous Amputation Prosthesis (ITAPTM).
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Amputation of Lower Extremity
Keywords
Osseointegration, Direct skeletal attachment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fixation of ITAP to lower limb amputees.
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Direct skeletal fixation of ITAP to lower limb amputees.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adhesion check in the skin surrounding the ITAP
Description
Skin reaction assessment reviews the adhesion to the Implant at surface layer
Time Frame
12 month post surgery
Title
Assessment of skin colour surrounding the ITAP
Description
Skin reaction assessment reviews the skin colour
Time Frame
12 month post surgery
Title
Measuring temperature of the skin surrounding the ITAP
Description
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
Title
Condition of the skin surrounding the ITAP
Description
Skin reaction assessment reviews the presence of exudate
Time Frame
12 month post surgery
Title
Pain at the end of stump
Description
Skin reaction assessment reviews the pain in the skin area surrounding the ITAP
Time Frame
12 month post surgery
Title
Swelling of the skin around the ITAP
Description
Skin reaction assessment reviews the swelling around the ITAP
Time Frame
12 month post surgery
Secondary Outcome Measure Information:
Title
Radiographic assessment to measure osseointegration
Description
Radiographic assessments to measure osseointegration
Time Frame
18 month post surgery
Title
Radiographic assessments to measure fixation of the ITAP
Description
Radiographic assessments to measure fixation of the ITAP
Time Frame
18 month post surgery
Title
Microbiological assessment of the stump by standard microbiological screen.
Description
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
Title
Calculate QTFA to measure quality of life
Description
General quality of life through Q-TFA ( Questionnaire for persons with a transfemoral amputation)
Time Frame
18 month post surgery
Title
Calculate SIGAM to measure Limb specific mobility
Description
Limb specific measure of mobility through the SIGAM mobility grades
Time Frame
18 month post surgery
Title
Gait analysis at 18 months to measure mobility
Description
Gait analysis in patients where appropriate and possible (this data will not be collected in the CRF)
Time Frame
18 month post surgery
Title
Subjective Qualitative Interview at 18 months to assess patient outcome
Description
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
Title
Assessment of adverse events throughout the clinical trial
Description
Device-related and procedure-related complications will be analysed to assess device safety.
Time Frame
18 month post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mr Robert Grimer
Organizational Affiliation
ROH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Orthopaedic
City
Birmingham
ZIP/Postal Code
B31 2AP
Country
United Kingdom
Facility Name
Royal National Orthopaedic Hospital
City
Stanmore
ZIP/Postal Code
HA7 4LP
Country
United Kingdom
12. IPD Sharing Statement
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Intraosseous Transcutaneous Amputation Prosthesis
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