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Intraosseous Transcutaneous Amputation Prosthesis ((ITAP))

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02491424
Recruitment Status : Completed
First Posted : July 8, 2015
Last Update Posted : October 22, 2018
Sponsor:
Information provided by (Responsible Party):
Stryker Orthopaedics

Tracking Information
First Submitted Date  ICMJE June 15, 2015
First Posted Date  ICMJE July 8, 2015
Last Update Posted Date October 22, 2018
Study Start Date  ICMJE January 2007
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2015)
  • Adhesion check in the skin surrounding the ITAP [ Time Frame: 12 month post surgery ]
    Skin reaction assessment reviews the adhesion to the Implant at surface layer
  • Assessment of skin colour surrounding the ITAP [ Time Frame: 12 month post surgery ]
    Skin reaction assessment reviews the skin colour
  • Measuring temperature of the skin surrounding the ITAP [ Time Frame: 12 month post surgery ]
    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 [ Time Frame: 12 month post surgery ]
    Skin reaction assessment reviews the presence of exudate
  • Pain at the end of stump [ Time Frame: 12 month post surgery ]
    Skin reaction assessment reviews the pain in the skin area surrounding the ITAP
  • Swelling of the skin around the ITAP [ Time Frame: 12 month post surgery ]
    Skin reaction assessment reviews the swelling around the ITAP
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2015)
  • Radiographic assessment to measure osseointegration [ Time Frame: 18 month post surgery ]
    Radiographic assessments to measure osseointegration
  • Radiographic assessments to measure fixation of the ITAP [ Time Frame: 18 month post surgery ]
    Radiographic assessments to measure fixation of the ITAP
  • Microbiological assessment of the stump by standard microbiological screen. [ Time Frame: 18 month post surgery ]
    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 [ Time Frame: 18 month post surgery ]
    General quality of life through Q-TFA ( Questionnaire for persons with a transfemoral amputation)
  • Calculate SIGAM to measure Limb specific mobility [ Time Frame: 18 month post surgery ]
    Limb specific measure of mobility through the SIGAM mobility grades
  • Gait analysis at 18 months to measure mobility [ Time Frame: 18 month post surgery ]
    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 [ Time Frame: 18 month post surgery ]
    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 [ Time Frame: 18 month post surgery ]
    Device-related and procedure-related complications will be analysed to assess device safety.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intraosseous Transcutaneous Amputation Prosthesis
Official Title  ICMJE Direct Skeletal Fixation of Prosthetic Limbs Following Trans- Femoral Amputation - Study of an Intraosseous Transcutaneous Amputation Prosthesis (ITAP)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Traumatic Amputation of Lower Extremity
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Fixation of ITAP to lower limb amputees.

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: Device: Direct skeletal fixation of ITAP to lower limb amputees.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 2, 2015)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02491424
Other Study ID Numbers  ICMJE 06-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Stryker Orthopaedics
Original Responsible Party Stanmore Implants Ltd.
Current Study Sponsor  ICMJE Stryker Orthopaedics
Original Study Sponsor  ICMJE Stanmore Implants Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mr Robert Grimer ROH
PRS Account Stryker Orthopaedics
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP