AmputeesNCT02439463
Traumatic Below-knee Amputees With Prosthetics: Health-related Quality of Life and Locomotor Capabilities
An observational study of Amputees, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
The present study assesses the health-related quality of life and the locomotor capabilities major traumatic lower limb amputees who use prosthesis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputees
- What is being tested?
- Below-knee amputation
- Type of treatment
- Surgery or procedure
- How many people
- 26 participants
- Where
- 1 siteFinland
- Study dates
- Jun 2015to Jan 2018
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Below-knee amputees who use limb prosthesis
Who may be able to join
- Below-knee prosthesis users with amputation due to trauma
- age >18
Who cannot join
- 1. Patients with no prosthesis
Trial locations and contacts
1 site in 1 country.
About this study
The present study assesses the health-related quality of life and the locomotor capabilities major traumatic lower limb amputees who use prosthesis.
Read the detailed description
A cross sectional study based on a retrospective review of prosthetic using major traumatic lower limb amputees' demographic and clinical details together with HRQoL and locomotor capabilities patient-reported outcome measures.
- Conditions
- Amputees
- Being tested
- Below-knee amputation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Below-knee amputationProcedure or surgery
Patients with traumatic below-knee amputation.
What is being measured
The primary outcome is the main question the study is designed to answer.
The health-related quality of life measured by HRQoL score
Measured: 2-5 years
Locomotor capabilities of traumatic below-knee amputees with prothesis
Measured: 2-5 years
Secondary outcomes (2)
15D health-related quality of life instrument
Measured: 2-5 years
Prothesis Evaluation Questionnaire
Measured: 2-5 yeats
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study startJun 2015
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputeesStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 26 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jussi Repo, Helsinki University Central Hospital
- Investigators
- Erkki J Tukiainen, MD,PhD, Study director, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02439463
- Sponsor's protocol ID
- 364/13/03/02/2014/7
- Status last verified
- Feb 2018
- First submitted
- 5 May 2015
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traumatic Below-knee Amputees With Prosthetics: Health-related Quality of Life and Locomotor Capabilities
- ClinicalTrials.gov ID
- NCT02439463
- Acronym / sponsor ID
- 364/13/03/02/2014/7
- Conditions
- Amputees
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 8 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study assesses the health-related quality of life and the locomotor capabilities major traumatic lower limb amputees who use prosthesis.
Detailed description
A cross sectional study based on a retrospective review of prosthetic using major traumatic lower limb amputees' demographic and clinical details together with HRQoL and locomotor capabilities patient-reported outcome measures.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Below-knee amputees who use limb prosthesis
Key inclusion criteria (2 listed)
- Below-knee prosthesis users with amputation due to trauma
- age >18
Key exclusion criteria (1 listed)
- 1. Patients with no prosthesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Below-knee amputationPatients with traumatic below-knee amputation. | Procedure or surgery | – |
Primary outcome
The health-related quality of life measured by HRQoL score
Time frame: 2-5 years
Locomotor capabilities of traumatic below-knee amputees with prothesis
Time frame: 2-5 years
2 secondary outcomes
15D health-related quality of life instrument
Time frame: 2-5 years
Prothesis Evaluation Questionnaire
Time frame: 2-5 yeats
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erkki J Tukiainen, MD,PhD study director
Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputees, run by Helsinki University Central Hospital at 1 site in Finland.
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 2 inclusion and 1 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 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. 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?
The health-related quality of life measured by HRQoL score (time frame: 2-5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2018.