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Traumatic Amputation of Lower Extremity(ITAP)NCT02491424

Intraosseous Transcutaneous Amputation Prosthesis

A study testing Direct skeletal fixation of ITAP to lower limb amputees. in people with Traumatic Amputation of Lower Extremity, run by Stryker Orthopaedics at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Traumatic Amputation of Lower Extremity
What is being tested?
Direct skeletal fixation of ITAP to lower limb amputees.
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesUnited Kingdom
Study dates
Jan 2007to Jan 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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°
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  • 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

  • Royal Orthopaedic

    Birmingham, B31 2AP

  • Royal National Orthopaedic Hospital

    Stanmore, HA7 4LP

Other trials in United Kingdom

About this study

Official title: 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).

Read the 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.

Being tested
Direct skeletal fixation of ITAP to lower limb amputees.
Keywords
Osseointegration, Direct skeletal attachment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT02491424
Study groupRoleWhat they receive
Fixation of ITAP to lower limb amputees.ExperimentalDirect 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.
Receives: Device: Direct skeletal fixation of ITAP to lower limb amputees.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adhesion check in the skin surrounding the ITAP

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

    Measured: 12 month post surgery

  2. Assessment of skin colour surrounding the ITAP

    Skin reaction assessment reviews the skin colour

    Measured: 12 month post surgery

  3. 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

    Measured: 12 month post surgery

  4. Condition of the skin surrounding the ITAP

    Skin reaction assessment reviews the presence of exudate

    Measured: 12 month post surgery

  5. Pain at the end of stump

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

    Measured: 12 month post surgery

  6. Swelling of the skin around the ITAP

    Skin reaction assessment reviews the swelling around the ITAP

    Measured: 12 month post surgery

Secondary outcomes (8)

  1. Radiographic assessment to measure osseointegration

    Radiographic assessments to measure osseointegration

    Measured: 18 month post surgery

  2. Radiographic assessments to measure fixation of the ITAP

    Radiographic assessments to measure fixation of the ITAP

    Measured: 18 month post surgery

  3. 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.

    Measured: 18 month post surgery

  4. Calculate QTFA to measure quality of life

    General quality of life through Q-TFA ( Questionnaire for persons with a transfemoral amputation)

    Measured: 18 month post surgery

  5. Calculate SIGAM to measure Limb specific mobility

    Limb specific measure of mobility through the SIGAM mobility grades

    Measured: 18 month post surgery

  6. 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)

    Measured: 18 month post surgery

  7. 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

    Measured: 18 month post surgery

  8. Assessment of adverse events throughout the clinical trial

    Device-related and procedure-related complications will be analysed to assess device safety.

    Measured: 18 month post surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2015 (estimated)
  2. Study startJan 2007
  3. Primary completionJan 2016
  4. Study completionJan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02491424
Sponsor's protocol ID
06-01
Acronym
(ITAP)
Status last verified
Apr 2016
First submitted
15 Jun 2015
Last updated
22 Oct 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Direct skeletal fixation of ITAP to lower limb amputees. in people with Traumatic Amputation of Lower Extremity, run by Stryker Orthopaedics at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adhesion check in the skin surrounding the ITAP (time frame: 12 month post surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02491424.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2018.

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