Clinical trial NCT02491424: Intraosseous Transcutaneous Amputation Prosthesis
Official title: Direct Skeletal Fixation of Prosthetic Limbs Following Trans- Femoral Amputation - Study of an Intraosseous Transcutaneous Amputation Prosthesis (ITAP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Amputation of Lower Extremity
Keywords: Osseointegration
Direct skeletal attachment
Lead sponsor: Stryker Orthopaedics
Sponsor class: INDUSTRY
First posted: 2015-07-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Adhesion check in the skin surrounding the ITAP
timeFrame: 12 month post surgery
measure: Assessment of skin colour surrounding the ITAP
timeFrame: 12 month post surgery
measure: Measuring temperature of the skin surrounding the ITAP
timeFrame: 12 month post surgery
measure: Condition of the skin surrounding the ITAP
timeFrame: 12 month post surgery
measure: Pain at the end of stump
timeFrame: 12 month post surgery
measure: Swelling of the skin around the ITAP
timeFrame: 12 month post surgery
Secondary outcomes:
measure: Radiographic assessment to measure osseointegration
timeFrame: 18 month post surgery
measure: Radiographic assessments to measure fixation of the ITAP
timeFrame: 18 month post surgery
measure: Microbiological assessment of the stump by standard microbiological screen.
timeFrame: 18 month post surgery
measure: Calculate QTFA to measure quality of life
timeFrame: 18 month post surgery
measure: Calculate SIGAM to measure Limb specific mobility
timeFrame: 18 month post surgery
measure: Gait analysis at 18 months to measure mobility
timeFrame: 18 month post surgery
measure: Subjective Qualitative Interview at 18 months to assess patient outcome
timeFrame: 18 month post surgery
measure: Assessment of adverse events throughout the clinical trial
timeFrame: 18 month post surgery
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Royal Orthopaedic
city: Stanmore
country: United Kingdom
facility: Royal National Orthopaedic Hospital
Study officials:
affiliation: ROH
name: Mr Robert Grimer
role: PRINCIPAL_INVESTIGATOR
References: