Intraosseous Transcutaneous Amputation Prosthesis

NCT02491424 | Completed DMC

• 1 other identifier: 06-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

Direct Skeletal Fixation of Prosthetic Limbs Following Trans-Femoral Amputation - Study of an Intraosseous Transcutaneous Amputation Prosthesis (ITAPTM).

Conditions

Traumatic Amputation of Lower Extremity

Keywords

Osseointegration; Direct skeletal attachment

Outcome Measures

Primary Outcomes (6)

• Adhesion check in the skin surrounding the ITAP

  Skin reaction assessment reviews the adhesion to the Implant at surface layer

  12 month post surgery

• Assessment of skin colour surrounding the ITAP

  Skin reaction assessment reviews the skin colour

  12 month post surgery

• 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

  12 month post surgery

• Condition of the skin surrounding the ITAP

  Skin reaction assessment reviews the presence of exudate

  12 month post surgery

• Pain at the end of stump

  Skin reaction assessment reviews the pain in the skin area surrounding the ITAP

  12 month post surgery

• Swelling of the skin around the ITAP

  Skin reaction assessment reviews the swelling around the ITAP

  12 month post surgery

Secondary Outcomes (8)

• Radiographic assessment to measure osseointegration

  18 month post surgery

• Radiographic assessments to measure fixation of the ITAP

  18 month post surgery

• Microbiological assessment of the stump by standard microbiological screen.

  18 month post surgery

• Calculate QTFA to measure quality of life

  18 month post surgery

• Calculate SIGAM to measure Limb specific mobility

  18 month post surgery

Study Arms (1)

Fixation of ITAP to lower limb amputees.

EXPERIMENTAL

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.

Device: Direct skeletal fixation of ITAP to lower limb amputees.

Interventions

Direct skeletal fixation of ITAP to lower limb amputees. 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.

Fixation of ITAP to lower limb amputees.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Trans-femoral amputation
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stryker Orthopaedics: lead

Study Sites (2)

Royal Orthopaedic

Birmingham, B31 2AP, United Kingdom

Location

Royal National Orthopaedic Hospital

Stanmore, HA7 4LP, United Kingdom

Location

Study Officials

• Mr Robert Grimer

  ROH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2015
• First Posted: July 8, 2015
• Study Start: January 1, 2007
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: October 22, 2018

Record last verified: 2016-04

Locations

GB (2)