**VHA PROSTHETIC CLINICAL MANAGEMENT PROGRAM (PCMP)**

**CLINICAL PRACTICE RECOMMENDATIONS**

**MICROPROCESSOR KNEES**

I.  **[BACKGROUND]{.underline}**

> VHA\'s Prosthetic and Sensory Aids Strategic Healthcare Group was
> directed by the Under Secretary for Health to establish a Prosthetic
> Clinical Management Program (PCMP). The objectives are to coordinate
> the development of clinical practice recommendations for prosthetic
> prescriptive practices and contracting opportunities to assure
> technology uniformity and ease of access to prosthetic prescriptions
> and patient care that will lead to valid outcome measures and analysis
> for research purposes.
>
> The New Technology Subgroup of the Pre-Post National Amputation
> Workgroup met in April 2004, to develop a proposal to define patient
> selection and identification criteria for Microprocessor Prosthetic
> Knees. Their proposal is based on recommendations arising from the May
> 2003 Microprocessor Prosthetic Knee Forum, hosted at Walter Reed Army
> Medical Center and sponsored and funded by the American Academy of
> Orthotists and Prosthetists. The criteria as presented in this
> document have been endorsed by the Pre-Post National Amputation
> Workgroup Chairperson, and thus, are ready to incorporate as
> Prosthetic Clinical Management (PCM) Clinical Practice
> Recommendations.

II. **[POLICY]{.underline}**

> The purpose of the Clinical Practice Recommendations is to assist
> practitioners in clinical decision-making and to standardize and
> improve the quality of patient care.

III. **[PATIENT SELECTION AND IDENTIFICATION]{.underline}**

     A.  [Contraindications for use of the microprocessor knee should
         include]{.underline}:

-   Any condition which prevents socket fitting, such as a complicated
    wound or intractable pain which precludes socket wear.

-   Inability to tolerate the weight of the prosthesis.

-   Medicare Level K 0---no ability or potential to ambulate or
    transfer.

-   Medicare Level K 1---limited ability to transfer or ambulate on
    level ground at fixed cadence.

-   Medicare Level K 2---limited community ambulator that does not have
    the cardiovascular reserve, strength, and balance to improved
    stability in stance to permit increased independence, less risk of
    falls, and potential to advance to a less restrictive walking
    device.

-   Inability to utilize swing and stance features of the knee unit.

-   Poor balance or ataxia that limits ambulation.

-   Significant hip flexion contracture (over 20 degrees).

-   Significant deformity of remaining limb that would impair ability to
    stride.

-   Limited cardiovascular and/or pulmonary reserve or profound
    weakness.

-   Limited cognitive ability to understand gait sequencing or care
    requirements.

-   Long distance or competitive running.

-   Falls outside of recommended weight or height guidelines of
    manufacturer.

-   Specific environmental factors---such as excessive moisture or dust,
    or inability to charge the prosthesis.

-   Extremely rural conditions where maintenance ability is limited.

    A.  [Indications for use of the microprocessor knee should
        include]{.underline}:

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-   Adequate cardiovascular and pulmonary reserve to ambulate at
    variable cadence.

-   Adequate strength and balance to stride to activate the knee unit.

-   Should not exceed the weight or height restrictions of the device.

-   Adequate cognitive ability to master technology and gait
    requirements of device.

-   Hemi-pelvectomy through knee-disarticulation level of amputation,
    including bilateral lower extremity amputees are candidates if they
    meet functional criteria as listed.

-   Patient is an active walker and requires a device that reduces
    energy consumption to permit longer distances with less fatigue.

-   Daily activities or job tasks that do not permit full focus of
    concentration on knee control and stability---such as uneven
    terrain, ramps, curbs, stairs, repetitive lifting and/or carrying.

-   Medicare Level K 2---limited community ambulator, but only if
    improved stability in stance permits increased independence, less
    risk of falls, and potential to advance to a less restrictive
    walking device, and patient has cardiovascular reserve, strength,
    and balance to utilize the prosthesis. *The microprocessor enables
    fine-tuning and adjustment of the hydraulic mechanism to accommodate
    the unique motor skills and demands of the functional level K2
    ambulator.*

-   Medicare Level K 3---unlimited community ambulator.

-   Medicare Level K 4---active adult, athlete, who has the need to
    function as a K 3 level in daily activities.

-   Potential to lessen back pain by providing more secure stance
    control, using less muscle control to keep knee stable.

-   Potential to unload and decrease stress on remaining limb.

-   Potential to return to an active lifestyle.

    A.  [Physical and Functional Fitting Criteria for New
        Amputees]{.underline}:

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-   New Amputees may be considered if they meet certain criteria as
    outlined above.

-   Pre-morbid and current functional assessment important determinant.

-   Requires stable wound and ability to fit socket.

-   Immediate Post-operative fit is possible.

-   Must have potential to return to active lifestyle.

##### 

##### EVALUATION AND DOCUMENTATION

> Documentation must clearly identify the status of the patient to
> justify the prosthetic need related to the areas of Prosthetic,
> Physical, Functional and Coding rationalization.
>
> [*"Prosthetic"* documentation must]{.underline}:

-   Verify the status of foot, knee and socket.

-   Identify rational to replace existing components.

-   Clarify why present components do not enable the patient to achieve
    activities of daily living (ADL).

> [*"Physical"* documentation must]{.underline}:

-   Verify the patients age, gender, weight, specific amputation level
    and cause and date of amputation.

-   Identify any related, relevant and or related physical conditions.

> [*"Functional"* documentation must]{.underline}:

-   Clearly establish the patients functional needs related to ADL.

-   Establish the patient's functional level.

> [*"Coding"* documentation must]{.underline}:

-   Establish the patient's specific ADL related to the specific L-code
    functions related to the components:

    -   Microprocessor Controlled Stance

    -   Pylon with Force Sensors

    -   Extension Dampening and Stance Flexion

    -   High activity Frame

    -   Fluid Swing Phase Control

    -   Microprocessor-Controlled swing

    -   Continuous Gait Assessment

    -   Lithium Ion Battery Re-charger

> A local evaluation process and form is recommended to ensure clear,
> concise and uniform documentation for a microprocessor-controlled knee
> component.

## PROSTHETIC TRAINING

Standard therapy procedures and protocols should be applied when
treating and training an individual to function with a microprocessor
knee mechanism. The fundamental muscle movements, skeletal position and
posture to ambulate and initiate function with the
microprocessor-controlled knee will be similar if not the same when
compared to a non microprocessor-controlled knee.

# Functional Goals

-   Ability to assess skin care of residual and sound limb.

-   Ability to successfully wrap or apply a shrinker to the residual
    limb.

-   Ability to assume various positions to avoid hip and knee
    contractures.

-   Ability to independently strengthen the residual limb, sound limb
    and upper extremities.

-   Ability to perform independent cardiovascular and desensitization
    activities.

-   Ability to apply and remove prosthesis independently.

-   Ability to transfer from/to wheelchair/bed/commode and, if
    appropriate, wheelchair to tub and floor to wheelchair.

-   Ability to perform weight-shifting activities with and without the
    prosthesis.

-   Ability to independently dress, bathe, groom, etc.

-   Ability to independently perform household chores, e.g., cooking,
    cleaning, and grocery shopping.

-   Ability to independently transfer into a car.

# Ambulatory Goals

-   Ability to apply and remove prosthesis independently.

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-   Ability to ambulate functional distances on level surfaces and

> stairs independently with appropriate assistive device as
>
> needed.

-   Ability to ascend and descend inclines and stairs, pick up an

> object and clear an obstacle independently.

-   Ability to fall and rise from the floor with assistance of one.

VI\. **[REFERENCES]{.underline}**

Buckley JG, Spence WD, Solomonidis SE. Energy cost of walking:
comparison of "intelligent prosthesis" with conventional mechanism.
*Archives of Physical Medicine and Rehabilitation* 1997; 78(3):330-333.

Bodily CK, Burgess EM, Contralateral limb and patient survival after
amputation. *American Journal of Surgery* 146:280-282. 1983

Datta D, Howitt J. Conventional versus microchip controlled pneumatic
swing phase control for transfemoral amputees: user's verdict.
*Prosthetics and Orthotics International* 1998; 22(2):129-135.

Flynn, Daren, DDS, MS., Computerized Lower Limb Prosthetis. *VA
Technology Assessment Program Short Report* (MDRC 152M), March 2000,
Number 2

Helm P, Engle T, Holm A, et al. Function after lower limb amputation.
*Acta Orthopaedica Scandinavica* 1986; 57(2):154-157.

Kastner J, Nimmervoll R, Wagner IP. "Was kann das
C-Leg?"-Ganganalytischer Verleich von C-Leg, 3R45 and 3R80. *Med Orth
Tech* 1999; 119(5):131-137.

Kirker S, Keymer S, Talbot J, Lachmann S. An assessment of the
intelligent knee prosthesis. *Clinical Rehabilitation* 1996;
10(3):267-273.

Medhat A, Huber PM, Medhat MA. Factors that influence the level of
activities in persons with lower extremity amputation. *Rehabilitation
Nursing* 1190; 15(1):13-18.

Medical Devices Agency. Department of Health. UK. *The EndoLite
Intelligent Prosthesis*. Report Number MDA/P94/03. 1994, Medical Devices
Agency: Surbiton.

Michael JW. Modern prosthetic knee mechanisms. *Clinical Orthopaedics
and Related Research* 1999; 361(47):39-47.

Mueller MJ, Delitto A. Selective criteria for successful long-term
prosthetic use. *Physical Therapy* 1985; 65(7):1037-1040.

Nissen SJ, Newman WP. Factors influencing reintegration to normal living
after amputation. *Archives of Physical Medicine and Rehabilitation*
1992; 73(6):548-551.

Pernot HFM, De Witte LP, Lindeman E Et al. Daily functioning of the
lower extremity amputee: an overview of the literature. *Clinical
Rehabilitation* 11:93-106.

Staros A, Rubin G. Prescription considerations in modern above-knee
prosthesis. *Physical Medicine and Rehabilitation Clinics of North
America* 1991; 2(2):311-324

**APPROVED/DISAPPROVED:**
\_\_\_\_\_[SIGNED]{.underline}\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Jonathan B. Perlin, MD, PhD, MSHA, FACP

Acting Under Secretary for Health

Date: \_\_\_[9/24/04]{.underline}\_\_\_\_\_\_\_\_\_\_\_\_\_\_