BlueCross BlueShield of Tennessee Medical Policy Manual

Patient-Specific Cutting Guides and Custom Knee Implants

DESCRIPTION

A total knee replacement involves the shaping of the bony articulating surfaces within the knee to receive metal and polyethylene implants. The largest variable in controlling patient outcome is the angles at which the implant is inserted. The more accurate the surgery is in terms of the angles of cuts made in the bone, the better the fit of the prosthesis as well as improving the patient's function and decreasing their pain. Custom knee implants and patient-specific cutting guides have been proposed as alternatives to off-the-shelf implants and conventional cutting guides for joint arthroplasty. Custom implants and patient specific cutting guides are constructed with the aid of preoperative 3-dimensional computed tomography (CT) or magnetic resonance imaging (MRI) scans and proprietary planning software. This digital image is then used to create a single use, disposable customized cutting block for that patient.

POLICY

See also:  Autologous Chondrocyte Implantation (ACI)

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

A number of small randomized controlled trials have examined whether patient-specific cutting guides improve outcomes for total knee arthroplasty. Systematic reviews of these trials find no significant improvement in implant alignment, with some studies reporting worse alignment with patient-specific instrumentation. Based on the evidence available at this time, use of custom made implants and patient-specific cutting guides are considered investigational.

SOURCES

BlueCross BlueShield Association. Medical Policy Reference Manual. (8:2017). Patient-specific cutting guides and custom knee implants (7.01.144). Retrieved November 30, 2017 from BlueWeb. (6 articles and/or guidelines reviewed)

ECRI Institute. Emerging Technology Evidence Report. (2014, August). Custom total knee arthroplasty. Retrieved December 12, 2014 from ECRI Institute. (138 article and/or guidelines reviewed)

Nam, D., Nunley, R., Berend, K., Lombardi, A., & Barrack, R. (2016). The impact of custom cutting guides on patient satisfaction and residual symptoms following total knee arthroplasty. Knee, 23 (1), 144-148.  Abstract retrieved March 2, 2016 from PubMed database.

Nam, D., Park, A., Stambough, J., Johnson, S., Nunley, R., & Barrack, R. (2016). Custom cutting guides do not improve total knee arthroplasty clinical outcomes at 2 years followup. Clinical Orthopaedics and Related Research, 474 (1), 40-46. (Level 4 evidence)

Nankivell, M., West, G., & Pourgiezis, N. (2015). Operative efficiency and accuracy of patient-specific cutting guides in total knee replacement. ANZ Journal of Surgery, 85 (6), 452-455. Abstract retrieved January 18, 2017 from PubMed database.

Sassoon, A., Nam, D., Nunley, & Barrack, R. (2015). Systematic review of patient –specific instrumentation in total knee arthroplasty: new but not improved. Clinical Orthopaedics and Related Research, 473 (1), 151-158. (Level 1 evidence)

U. S. Food and Drug Administration. (2010, April). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K093806.  Retrieved December 15, 2014 from http://www.fda.gov.

U. S. Food and Drug Administration. (2010, April). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K122053.  Retrieved December 15, 2014 from http://www.fda.gov.

Winifred S. Hayes. Medical Technology Directory. (2016, September; last update search July 2017). Patient-specific instruments for total knee arthroplasty: a review of reviews. Retrieved November 30, 2017 from https://www.hayesinc.com.  (63 articles and/or guidelines reviewed)

ORIGINAL EFFECTIVE DATE:  4/9/2015

MOST RECENT REVIEW DATE:  1/25/2018

ID_BA

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

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