Effects of Microprocessor-controlled Knee Joints on Community Outcomes

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.

Study Overview

• Status: Unknown
• Conditions: People With Trans-femoral Amputation
• Intervention / Treatment: Device: Microprocessor-controlled knee joints; Device: Non-microprocessor-controlled knee joints

• Study Type: Observational
• Enrollment (Anticipated): 330

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Amputees registered with Amputee Rehabilitation Centres across the United Kingdom.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Not meeting inclusion criteria

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Device: Microprocessor-controlled knee joints; 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).; Device: Non-microprocessor-controlled knee joints; Any non-microprocessor-controlled knee joints such as prosthesis incorporating hydraulic, polycentric, pneumatic mechanisms, friction or locked knees.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Baseline

Collaborators and Investigators

• Sponsor: University of Derby
• Investigators: Principal Investigator: Reza Safari, University of Derby

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 15, 2020
• Primary Completion (ANTICIPATED): May 1, 2020
• Study Completion (ANTICIPATED): May 30, 2020

Study Registration Dates

• First Submitted: September 30, 2019
• First Submitted That Met QC Criteria: September 30, 2019
• First Posted (ACTUAL): October 2, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 2, 2019
• Last Update Submitted That Met QC Criteria: September 30, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Trans-femoral amputation; Limb prosthesis; Microprocessor Controlled Knee Joints; Community Outcome Measures
• Other Study ID Numbers: v1.2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make individual participant data available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No