Clinical Trial: Intraosseous Transcutaneous Amputation Prosthesis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Summary:

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.


Sponsor: Stanmore Implants Ltd.

Current Primary Outcome:

  • 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: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: Stanmore Implants Ltd.

Dates:
Date Received: June 15, 2015
Date Started: January 2007
Date Completion:
Last Updated: April 12, 2016
Last Verified: April 2016