Trials / Completed
CompletedNCT02491424
Intraosseous Transcutaneous Amputation Prosthesis
Direct Skeletal Fixation of Prosthetic Limbs Following Trans- Femoral Amputation - Study of an Intraosseous Transcutaneous Amputation Prosthesis (ITAP)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Stryker Orthopaedics · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2007-01-01
- Primary completion
- 2016-01-01
- Completion
- 2016-01-01
- First posted
- 2015-07-08
- Last updated
- 2018-10-22
Locations
2 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT02491424. Inclusion in this directory is not an endorsement.