Intraosseous Transcutaneous Amputation Prosthesis

NCT ID: NCT02491424

Last Updated: 2018-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2016-01-31

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.

Conditions

Traumatic Amputation of Lower Extremity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Direct skeletal fixation of ITAP to lower limb amputees.

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stryker Orthopaedics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mr Robert Grimer

Role: PRINCIPAL_INVESTIGATOR

ROH

Locations

Royal Orthopaedic

Birmingham, , United Kingdom

Royal National Orthopaedic Hospital

Stanmore, , United Kingdom

Countries

United Kingdom

Other Identifiers

06-01

Identifier Type: -

Identifier Source: org_study_id