Intraosseous Transcutaneous Amputation Prosthesis ((ITAP))

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

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

Study Overview

• Status: Completed
• Conditions: Traumatic Amputation of Lower Extremity
• Intervention / Treatment: Device: Direct skeletal fixation of ITAP to lower limb amputees.

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: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Birmingham, United Kingdom, B31 2AP
    • Royal Orthopaedic
  • Stanmore, United Kingdom, HA7 4LP
    • Royal National Orthopaedic Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic assessment to measure osseointegration	Radiographic assessments to measure osseointegration	18 month post surgery
Radiographic assessments to measure fixation of the ITAP	Radiographic assessments to measure fixation of the ITAP	18 month post surgery
Microbiological assessment of the stump by standard microbiological screen.	Microbiological assessment of the stump by standard microbiological screen. Data will only be recorded in the CRF in the event of an infection.	18 month post surgery
Calculate QTFA to measure quality of life	General quality of life through Q-TFA ( Questionnaire for persons with a transfemoral amputation)	18 month post surgery
Calculate SIGAM to measure Limb specific mobility	Limb specific measure of mobility through the SIGAM mobility grades	18 month post surgery
Gait analysis at 18 months to measure mobility	Gait analysis in patients where appropriate and possible (this data will not be collected in the CRF)	18 month post surgery
Subjective Qualitative Interview at 18 months to assess patient outcome	A voluntary short one hour interview at the end of the study to discuss practical and emotional aspects of the process	18 month post surgery
Assessment of adverse events throughout the clinical trial	Device-related and procedure-related complications will be analysed to assess device safety.	18 month post surgery

Collaborators and Investigators

• Sponsor: Stryker Orthopaedics
• Investigators: Principal Investigator: Mr Robert Grimer, ROH

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: June 15, 2015
• First Submitted That Met QC Criteria: July 2, 2015
• First Posted (Estimate): July 8, 2015

Study Record Updates

• Last Update Posted (Actual): October 22, 2018
• Last Update Submitted That Met QC Criteria: October 18, 2018
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Osseointegration; Direct skeletal attachment
• Additional Relevant MeSH Terms: Wounds and Injuries; Amputation, Traumatic
• Other Study ID Numbers: 06-01