Effects of Microprocessor-controlled Knee Joints on Community Outcomes

NCT ID: NCT04112901

Last Updated: 2019-10-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 330 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-15
• Study Completion Date: 2020-05-30

Brief 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. 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Microprocessor-controlled knee joints

Intervention Type: DEVICE

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 joints

Intervention Type: DEVICE

Any non-microprocessor-controlled knee joints such as prosthesis incorporating hydraulic, polycentric, pneumatic mechanisms, friction or locked knees.

Interventions

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).

Intervention Type: DEVICE

Non-microprocessor-controlled knee joints

Any non-microprocessor-controlled knee joints such as prosthesis incorporating hydraulic, polycentric, pneumatic mechanisms, friction or locked knees.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Derby

OTHER

Sponsor Role: lead

Responsible Party

Reza Safari

Research Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Reza Safari

Role: PRINCIPAL_INVESTIGATOR

University of Derby

Central Contacts

Reza Safari, PhD.

Role: CONTACT

m.safari@derby.ac.uk

+441332592418

Nicola Barnett

Role: CONTACT

n.barnett@derby.ac.uk

01332 592035

Other Identifiers

V1.2

Identifier Type: -

Identifier Source: org_study_id