People With Trans-femoral AmputationNCT04112901
Effects of Microprocessor-controlled Knee Joints on Community Outcomes
An observational study of People With Trans-femoral Amputation, run by University of Derby.
Trial summary
About 21% to 35% of people with limb loss are those who lost their limb at trans-femoral level (i.e. above the knee). The increasing number of diabetes-related limb loss (amputation) and the rising proportion of older adult amputees indicates more amputees with limited mobility in the future. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- People With Trans-femoral Amputation
- Type of treatment
- Medical device
- How many people
- 330 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2020to 30 May 2020
- 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 to 95 years
- All sexes
- Adult, Older adult
Study population: Amputees registered with Amputee Rehabilitation Centres across the United Kingdom.
Who may be able to join
- Unilateral transfemoral amputation or knee disarticulation
- ≤ K2 mobility grade OR SIGAM grade D or below; i.e. able to walk ≤ 50 meters on level ground,
- Users of either MPK or N-MPK for at least 6 months prior to the recruitment date.
Who cannot join
- Not meeting inclusion criteria
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Activity, Mobility, Social Functioning, Mental Health and Quality of Life Outcomes in Limited Mobility Transfemoral and Knee Disarticulation Amputees Using Microprocessor-Controlled Knees or Non-Microprocessor Controlled Knees in the United Kingdom: A Cohort Study
About 21% to 35% of people with limb loss are those who lost their limb at trans-femoral level (i.e. above the knee). The increasing number of diabetes-related limb loss (amputation) and the rising proportion of older adult amputees indicates more amputees with limited mobility in the future. Among other factors, prosthesis success highly depends on the function of the knee joints during daily activities.
Presently, there are two categories of prosthetic knee joints; microprocessor-controlled knees (MPKs) and non-microprocessor-controlled knees (n-MPKs). Whilst the n-MPKs are unable to change the knee stiffness, the MPKs alter the joint stiffness and speed of movement according to the users' walking speed.
Although past studies indicate that MPKs could result in reduced risk of falls, improved balance and activity in limited mobility amputees, there is a lack of strong evidence on the effect of MPKs on community outcomes. The aim of this study is to compare activity, mobility, social functioning, depression, anxiety, and health-related quality of life in limited mobility trans-femoral or through-knee (i.e. knee disarticulation) amputees who are users of MPKs prosthesis with users of a prosthesis with n-MPKs.
- Conditions
- People With Trans-femoral Amputation
- Being tested
- Microprocessor-controlled knee joints, Non-microprocessor-controlled knee joints
- Keywords
- Trans-femoral amputation, Limb prosthesis, Microprocessor Controlled Knee Joints, Community Outcome Measures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microprocessor-controlled knee jointsDevice
Any type of microprocessor-controlled knee joints will be considered; this includes those controlling stance phase only (e.g. Compact C-Leg), swing phase only (e.g. Smart IP), both swing and stance phases (e.g. Reho knee), or power generating knees (e.g. POWER knee Ossur).
Non-microprocessor-controlled knee jointsDevice
Any non-microprocessor-controlled knee joints such as prosthesis incorporating hydraulic, polycentric, pneumatic mechanisms, friction or locked knees.
| Study group | Role | What they receive |
|---|---|---|
| People with trans-femoral amputation or knee dis-articulation | include individuals with unilateral transfemoral amputation or knee disarticulation, with ≤ K2 mobility grade OR SIGAM grade D or below; i.e. able to walk ≤ 50 meters on level ground, who have been users of either microprocessor-controlled knee or non-microprocessor-controlled knee joint for at least 6 months prior to the recruitment date. Receives: Device: Microprocessor-controlled knee joints; Device: Non-microprocessor-controlled knee joints |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Form-36 Quality of Life (SF-36)
The SF-36 is a validated generic measure of health-related quality of life consisting of eight scales (physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions).
Measured: Baseline
Secondary outcomes (4)
Special Interest Group in Amputee Medicine (SIGAM)
SIGAM describe a single-item scale comprising six clinical grades (A -F) of amputee mobility. SIGAM is a self-report questionnaire with 21 dichotomous (Y/N) items and algorithm designed to facilitate grade assignment.
Measured: Baseline
Prosthetic Evaluation Questionnaire (PEQ); Mobility, Social Burden and Residual Limb Health Subscales.
These scales contain 22 questions (Mobility and transfer, n=13; social burden, n=3, residual limb health, n=6) using the visual analog scales. The PEQ is a valid and reliable measure of the prosthetic related quality of life. It consisted of nine sub-scales, which are not dependent on each other.
Measured: Baseline
Reintegration to Normal Living Index (RNLI)
RNLI measures the degree to which people with traumatic or incapacitating illness reintegrate into normal social activities (e.g. recreation, movement in the community, and interaction in the family or other relationships). Respondents rate 11 questions on Visual Analogue Scales.
Measured: Baseline
Hospital Anxiety and Depression Scale (HADS)
The HADS scale is used to measure the level of anxiety and depression a person experiencing. It comprises 14 items on the four-point Likert scale; Seven items on anxiety and seven items on depression.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start15 Jan 2020 (estimated)
- Primary completion1 May 2020 (estimated)
- Study completion30 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for People With Trans-femoral AmputationStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Derby
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reza Safari, University of Derby
- Investigators
- Reza Safari, Principal investigator, University of Derby
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04112901
- Sponsor's protocol ID
- V1.2
- Status last verified
- Sep 2019
- First submitted
- 30 Sep 2019
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make individual participant data available.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activity, Mobility, Social Functioning, Mental Health and Quality of Life Outcomes in Limited Mobility Transfemoral and Knee Disarticulation Amputees Using Microprocessor-Controlled Knees or Non-Microprocessor Controlled Knees in the United Kingdom: A Cohort Study
- ClinicalTrials.gov ID
- NCT04112901
- Acronym / sponsor ID
- V1.2
- Conditions
- People With Trans-femoral Amputation
- Keywords
- Trans-femoral amputation, Limb prosthesis, Microprocessor Controlled Knee Joints, Community Outcome Measures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- University of DerbyUniversity, hospital or other
- Study start
- 15 Jan 2020 (estimated)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 30 May 2020 (estimated)
- First posted
- 2 Oct 2019 (actual)
- 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.
About 21% to 35% of people with limb loss are those who lost their limb at trans-femoral level (i.e. above the knee). The increasing number of diabetes-related limb loss (amputation) and the rising proportion of older adult amputees indicates more amputees with limited mobility in the future. Among other factors, prosthesis success highly depends on the function of the knee joints during daily activities.
Presently, there are two categories of prosthetic knee joints; microprocessor-controlled knees (MPKs) and non-microprocessor-controlled knees (n-MPKs). Whilst the n-MPKs are unable to change the knee stiffness, the MPKs alter the joint stiffness and speed of movement according to the users' walking speed.
Although past studies indicate that MPKs could result in reduced risk of falls, improved balance and activity in limited mobility amputees, there is a lack of strong evidence on the effect of MPKs on community outcomes. The aim of this study is to compare activity, mobility, social functioning, depression, anxiety, and health-related quality of life in limited mobility trans-femoral or through-knee (i.e. knee disarticulation) amputees who are users of MPKs prosthesis with users of a prosthesis with n-MPKs.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People with trans-femoral amputation or knee dis-articulation | – | Device: Microprocessor-controlled knee joints, Device: Non-microprocessor-controlled knee jointsinclude individuals with unilateral transfemoral amputation or knee disarticulation, with ≤ K2 mobility grade OR SIGAM grade D or below; i.e. able to walk ≤ 50 meters on level ground, who have been users of either microprocessor-controlled knee or non-microprocessor-controlled knee joint for at least 6 months prior to the recruitment date. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Amputees registered with Amputee Rehabilitation Centres across the United Kingdom.
Key inclusion criteria (3 listed)
- Unilateral transfemoral amputation or knee disarticulation
- ≤ K2 mobility grade OR SIGAM grade D or below; i.e. able to walk ≤ 50 meters on level ground,
- Users of either MPK or N-MPK for at least 6 months prior to the recruitment date.
Key exclusion criteria (1 listed)
- Not meeting inclusion criteria
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 |
|---|---|---|
| Microprocessor-controlled knee jointsAny type of microprocessor-controlled knee joints will be considered; this includes those controlling stance phase only (e.g. Compact C-Leg), swing phase only (e.g. Smart IP), both swing and stance phases (e.g. Reho knee), or power generating knees (e.g. POWER knee Ossur). | Device | People with trans-femoral amputation or knee dis-articulation |
| Non-microprocessor-controlled knee jointsAny non-microprocessor-controlled knee joints such as prosthesis incorporating hydraulic, polycentric, pneumatic mechanisms, friction or locked knees. | Device | People with trans-femoral amputation or knee dis-articulation |
Primary outcome
Short Form-36 Quality of Life (SF-36)
Time frame: Baseline
The SF-36 is a validated generic measure of health-related quality of life consisting of eight scales (physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions).
4 secondary outcomes
Special Interest Group in Amputee Medicine (SIGAM)
Time frame: Baseline
Prosthetic Evaluation Questionnaire (PEQ); Mobility, Social Burden and Residual Limb Health Subscales.
Time frame: Baseline
Reintegration to Normal Living Index (RNLI)
Time frame: Baseline
Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- Individual participant dataSharing planned: No. There is not a plan to make individual participant data available.
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.
Reza Safari principal investigator
University of Derby
Questions about this trial
What is this clinical trial studying?
An observational study of People With Trans-femoral Amputation, run by University of Derby.
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 3 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: status not confirmed, as of the sponsor's last update on 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reza Safari, PhD. (+441332592418, m.safari@derby.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Form-36 Quality of Life (SF-36) (time frame: Baseline). 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 2 Oct 2019.