How are you taking part in this consultation?

You will not be able to change how you comment later.

You must be signed in to answer questions

    The content on this page is not current guidance and is only for the purposes of the consultation process.

    Interventional procedure overview of direct skeletal fixation of limb prostheses using an intraosseous transcutaneous implant

    Closed for comments This consultation ended on at   Request commenting lead permission

    Outcome measures

    The main outcomes included functional outcomes, QOL and adverse events.

    The measures used were:

    • PROMs

    • HRQOL: A measure of the impact of a person's health status on their QOL. HRQOL tools allow the effects of chronic illness, treatment, and disability on a person's QOL to be measured. It is measured using validated outcome measures such as Q-TFA and SF-36.

    • Q-TFA: A self-report outcome measure for non-elderly people who have had an above-knee amputation and use a socket or OIP implant. It provides a score of 0 to 100 in the following 4 domains:

      • Prosthetic use: The number of days per week the person normally wears their prosthesis, multiplied by the number of hours it is used each day. A score of 100 means the prosthesis is used 7 days a week for more than 15 hours per day.

      • Prosthetic mobility: The ability and performance of the person to move, change and maintain postures when using the prosthesis. A score of 100 indicates the best possible prosthetic mobility. The mobility score is the average of 3 subscores:

        • capability (12 items)

        • use of walking aid (2 items), and

        • walking habits (5 items).

      • Problem score: This measures specific problems related to the amputation and prosthesis and their impact on QOL. A higher score indicates more serious problems (unlike the other domains).

      • Global health score: This measures the person's perception of their functional ability, any problems with the prosthesis, and their overall circumstances. The score is a summary of 3 questions to which answers are given on a 5-point Likert scale. A score of 100 indicates the best possible overall situation.

    • SF-36: A generic measure of QOL. The tool has 8 subscales:

      • 4 measure physical health:

        • physical functioning

        • role functioning – physical

        • bodily pain

        • general health, and

      • 4 measure mental and psychological health:

        • vitality

        • social functioning

        • role functioning – emotional

        • mental health.

    The results are also captured in 2 summary measures:

    • PCS and

    • MCS.

      In each scale, values run between 0 and 100. A higher score indicates better physical or mental health.

      • PMQ: A questionnaire with 12 questions about mobility in everyday life, which are answered on a 5-step Likert scale. Higher scores represent better mobility, with the maximum total score of 40.

      • Healthcare professional outcome measures

      • 6MWT: Measures the distance a person can walk in a 6-minute period and has been shown to reliably measure functional capacity in various populations, including people who have had amputations.

      • TUG test: A valid test for quantifying functional mobility and useful for following clinical change over time. It is a measure of function that correlates with balance and risk of fall. The test is quick, reliable and measures the time a person takes to rise from a chair, walk 3 metres, walk back, and sit down. The TUG test is interpreted as follows:

        • 10 seconds or less: normal mobility

        • between 10 and 20 seconds: mild mobility impairment, can go out alone, mobile without a gait aid

        • between 20 and 30 seconds: significant mobility problems, cannot go outside alone, needs a gait aid.

      • AMP: A reliable, valid measure for assessing mobility in people who have had a lower-limb amputation, with or without using a prosthesis (AMPPRO and AMPnoPRO, respectively). It can be used before prosthetic fitting to predict functional ability after prosthetic fitting. AMPPRO scores are presented as K-levels. This is a 5-level rating system used by the US Medicare health insurance program to indicate the extent of a person's disability and their potential for rehabilitation. Ratings range from 0 (no potential to walk independently, even with a prosthesis) to 4 (exceeds basic ambulation skills).

      • Prosthetic activity grades: Activity is graded between 0 and 4 and combines the extent of prosthetic use, use of walking aids, outdoor walking habits, and other activities using the prosthesis. The activity is captured from Q-TFA items and medical records.

        • 0: Do not use prosthesis; no prosthetic activity

        • 1 (Low): Limited use of prosthesis for standing or walking, use walking aid, no long walks

        • 2 (Average): Uses prosthesis most of the day, with or without walking aid at home, uses walking aid outdoors

        • 3 (High): Uses prosthesis for a full day, no walking aid except for longer distances, walks a lot, rarely performs other demanding or high-load activities using the prosthesis

        • 4 (Very High): Uses prosthesis for a full day, no walking aid, walks a lot or routinely performs other highly demanding or high-load activities involving the prosthesis (for example, cycling or gym training).