National Imaging Associates, Inc. Clinical guidelines: KNEE ARTHROPLASTY CPT CODES: Revision Knee Arthroplasty: 27486, 27487, 27488, 27438 Total Knee Arthroplasty (TKA): 27447 Partial-Unicompartmental Knee Arthroplasty (UKA): 27446 Guideline Number: NIA_CG_315 Responsible Department: Clinical Operations

Original Date:

November 2015

Last Review Date:

December 2016

Last Revised Date: Implementation Date:

January 2017 April 2017

INTRODUCTION: Arthroplasty describes the surgical replacement or reconstruction of a joint with implanted devices when the joint has been damaged by an arthritic or traumatic process. This guideline outlines the clinical indications for three types of knee arthroplasty procedures: total, partial/unicompartmental, and revision arthroplasty. Initial Clinical Reviewers (ICRs) and Physician Clinical Reviewers (PCRs) must be able to apply criteria based on individual needs and based on an assessment of the local delivery system. This guideline is structured with clinical indications outlined for each of the following applications: Total Knee Arthroplasty (TKA), Unilateral Knee Arthroplasty (UKA), and Revision Arthroplasty. I. Total Knee Arthroplasty (TKA) II. Unicompartmental Knee Arthroplasty (UKA) III. Revision Arthroplasty I.

Total Knee Arthroplasty (TKA) Total Knee Arthroplasty (TKA) describes reconstruction of all articular joint surfaces. 1) TKA may be considered medically necessary for treatment of the following knee joint pathology: a) Extensive disease or damage due to rheumatoid arthritis, fracture, or avascular necrosis confirmed by imaging (radiographs, MRI or other advanced imaging); AND b) Patient has pain and documented loss of function (no indication to perform TKA in patient with severe disease and no symptoms); OR c) When ALL of the following criteria are met:

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i)

Pain that is persistent and severe and/or patient has documented loss of function that has been present for at least 6 months resulting in a diminished quality of life; AND ii) At least 3 months of non-operative care* that has failed to improve symptoms. Non-operative care should include at least two or more of the following: I. Rest or activity modifications/limitations; II. Weight reduction for patient with elevated BMI; III. Protected weight-bearing with cane, walker or crutches; IV. Physical therapy modalities; V. Supervised home exercise; VI. Pharmacologic treatment: oral/topical NSAIDS, acetaminophen, analgesics; VII. Brace/orthosis; VIII. Injections: cortisone/viscosupplementation/PRP (platelet rich plasma); AND d) Physical exam findings demonstrate one or more of the following: tenderness, swelling/effusion, limited range of motion (decreased from uninvolved side or as compared to a normal joint), flexion contracture, palpable or audible crepitus, instability and/or angular deformity; AND e) Radiographic findings show evidence of bicompartmental or tricompartmental advanced arthritic changes, documented by standing, weight-bearing radiographs described as Kellgren-Lawrence (K-L)** stage III or stage IV degeneration (NOTE: MRI should not be the primary tool used to determine the presence or severity of arthritic changes in the joint); AND f) No injection into the joint within 3 months of surgery. NOTE: All requests for simultaneous bilateral total knee replacements will be reviewed on a case by case basis. g) All requests for TKA in patients with chronic, painless effusion and extensive radiographic arthritis will be evaluated on a case-by-case basis. **Kellgren-Lawrence Grading System: Grade 0: No radiographic features of osteoarthritis Grade I: Possible joint space narrowing and osteophyte formation Grade II: Definite osteophyte formation with possible joint space narrowing Grade III: Moderate multiple osteophytes, definite narrowing of joint space, some sclerosis and possible deformity of bone contour Grade IV: Large osteophytes, marked narrowing of joint space, severe sclerosis and definite deformity of bone contour; 2) Contraindications: a) Absolute contraindication: i) Active infection (local or remote) 2— Knee Arthroplasty 2017 v2

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ii)

Any injection into the joint within 3 months of surgery

b) Relative contraindication: Any of the following: i) Prior infection at site (unless aspiration with cultures and serology [CBC with differential, ESR, CRP] demonstrates no infection). If prior infection at site, tissue biopsies should be sent intra-operatively to exclude latent/dormant infection. ii) Extreme morbid obesity (BMI > 40) iii) Extensor mechanism deficiency iv) Neuropathic joint v) Severe peripheral vascular disease vi) Compromised soft tissue envelope vii) Uncontrolled comorbidities II.

Unicompartmental Knee Arthroplasty (UKA)/Partial Knee Replacement (PKA) Unicompartmental knee arthroplasty (UKA) is also called partial, hemi- or unicondylar knee, bicondylar knee arthroplasty, and involves reconstruction of either the medial (more common than lateral) or lateral weight bearing compartment of the knee and/or patellofemoral joint 1) UKA/PKA may be medically necessary when ALL of the following criteria are met: a) Pain localized to the medial or lateral compartment is present for at least 6 months; AND b) At least 3 months of non-operative care that has failed to improve symptoms. *Non-operative care should include at least two or more of the following: i) Rest or activity modifications/limitations; ii) Weight optimization; iii) Protected weight-bearing with cane, walker or crutches; iv) Physical therapy modalities; v) Supervised home exercise; vi) Pharmacologic treatment: oral/topical NSAIDS, acetaminophen, analgesics; vii) Brace/orthosis; viii) Injections: cortisone/viscosupplementation/PRP (platelet rich plasma); AND c) Total arc of motion (goniometer) > 90 degrees; AND d) Normal ACL or stable reconstructed ACL per physical exam test; AND e) Age > 50 years; AND f) Radiographic findings demonstrate only unicompartmental disease (with or without patellofemoral involvement) with evidence of degeneration equal to K-L* Grade 3 or 4 (NOTE: MRI should not be the primary tool used to determine the presence or severity of arthritic changes in the joint); AND

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g) Contracture < 5-10 degrees upon physical exam (goniometer); AND h) Angular deformity < 10 passively correctable to neutral upon physical exam (goniometer); AND i) BMI < 40; AND j) No injection into the joint within 3 months of surgery. NOTE: All requests for UKA in patients with chronic, painless effusion and extensive radiographic arthritis will be evaluated on a case-by-case basis. **Kellgren-Lawrence Grading System: Grade 0: No radiographic features of osteoarthritis Grade I: Possible joint space narrowing and osteophyte formation Grade II: Definite osteophyte formation with possible joint space narrowing Grade III: Moderate multiple osteophytes, definite narrowing of joint space, some sclerosis and possible deformity of bone contour Grade IV: Large osteophytes, marked narrowing of joint space, severe sclerosis and definite deformity of bone contour Outerbridge Arthroscopic Grading System Grade 0 Normal cartilage Grade I Softening and swelling Grade II Partial thickness defect, fissures < 1.5cm diameter Grade III Fissures down to subchondral bone, diameter > 1.5cm Grade IV Exposed subchondral bone 2) Contraindications: a) Any injection into the joint within 3 months of surgery b) Local or systemic active infection c) Inflammatory arthritis d) Angular deformity or contracture greater than indicated range e) Significant arthritic involvement of other knee compartments f) Ligamentous instability (at least ACL [anterior cruciate ligament]) g) Poor bone quality or significant osteoporosis or osteopenia h) Meniscectomy of the opposite compartment i) Stiffness greater than indicated range of motion III.

Revision Arthroplasty Revision describes surgical reconstruction due to failure or complication of a previous arthroplasty. 1) Revision TKA may be considered medically necessary when the following criteria are met:

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a) Previous UKA/PKA or TKA joint; AND b) Infection ruled out by synovial fluid aspiration/biospy (cell count and/or culture) AND off antibiotics; OR c) When ALL of the following criteria are met: i) Symptomatic UKA/PKA or TKA as evidence by persistent, severe disabling pain and loss of function; AND ii) Any of the following upon physical exam: tenderness to palpation objectively attributable to the implant, swelling or effusion, pain on weight-bearing or motion, instability on stress-testing, abnormal or limited motion compared to usual function), palpable or audible crepitus associated with reproducible pain; AND iii) Aseptic loosening, osteolysis confirmed on radiographic or advanced imaging (nuclear medicine bone scan, CT scan, MRI); AND d) No injection into the joint within 3 months of surgery; 2) Contraindications: a) Absolute contraindication: i) Local or systemic active infection ii) Any injection into the joint within 3 months of surgery b) Relative contraindication: Any of the following: i) Deficiency of the extensor mechanism ii) Neuropathic joint iii) Unstable or poorly controlled comorbidities iv) Severe peripheral vascular disease v) Compromised soft-tissue envelope (revision may be performed in conjunction with plastic surgical consultation for soft tissue coverage via pedicle flaps or other acceptable procedure) IV.

Non-Covered Services: 1) The following procedures are not considered a covered service and are not reimbursable based on lack of current scientific evidence for clinically important improvement, safety or efficacy; or based on scientific evidence of increased risk of serious complications: I. Procedures utilizing computer-navigated or patient-specific or genderspecific instrumentation II. Bicompartmental arthroplasty (investigational at this time) III. Robot-assisted TKA (Makoplasty)

V.

Other issues: 1) Manipulation following total knee arthroplasty: a) Nonsurgical treatment is initial treatment b) However, manipulation is indicated if within 3 months from time of primary arthroplasty if physical therapy is unable to improve motion to satisfactory degree

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i) ii)

If cause of arthrofibrosis/stiffness is due to technical error (component malpositioning or inappropriate sizing), then surgical revision arthroplasty is indicated If cause of arthrofibrosis/stiffness is due to adhesions/capsular contraction, then either arthroscopic or open lysis of adhesions is indicated

2) Poor dental hygiene (e.g. tooth extraction should be performed prior to arthroplasty). Major dental work within 2 year after a joint replacement MAY lead to seeding of the implant and possible revision surgery. If possible, all dental work must be completed prior to shoulder arthroplasty as these procedures increase risk for infection. Following surgery, patients should receive antibiotics for routine dental check-ups for a minimum of two years.

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VI.

REFERENCES 1) Alizai, Hamza, et al. "An update on risk factors for cartilage loss in knee osteoarthritis assessed using MRI-based semiquantitative grading methods." (2014). 2) Annaswamy, Thiru M., et al. "The Role of Intra-articular Hyaluronic Acid in Symptomatic Osteoarthritis of the Knee." PM&R 7.9 (2015): 995-1001. 3) Banerjee, Samik, et al. "Robotic-assisted knee arthroplasty." Expert Review of Medical Devices 12.6 (2015): 727-735. 4) Belmont, Philip J., et al. "Thirty-Day Postoperative Complications and Mortality Following Total Knee Arthroplasty Incidence and Risk Factors Among a National Sample of 15,321 Patients." The Journal of Bone & Joint Surgery 96.1 (2014): 20-26. 5) Bolognesi, Michael P., et al. "Unicompartmental Knee Arthroplasty and Total Knee Arthroplasty Among Medicare Beneficiaries, 2000 to 2009." The Journal of Bone & Joint Surgery 95.22 (2013): e174-1. 6) Cancienne, Jourdan M., et al. "Does timing of previous intra-articular steroid injection affect the post-operative rate of infection in total knee arthroplasty?." The Journal of arthroplasty 30.11 (2015): 1879-1882. 7) Cram, Peter, et al. "Total knee arthroplasty volume, utilization, and outcomes among Medicare beneficiaries, 1991-2010." JAMA 308.12 (2012): 1227-1236. 8) D’Apuzzo, Michele R., Wendy M. Novicoff, and James A. Browne. "The John Insall Award: Morbid Obesity Independently Impacts Complications, Mortality, and Resource Use After TKA." Clinical Orthopaedics and Related Research® (2014): 1-7. 9) Dudhniwala, A. G., et al. "Early failure with the Journey-Deuce bicompartmental knee arthroplasty." European Journal of Orthopaedic Surgery & Traumatology (2016): 1-5. 10) Emrani, P. S.; Katz, J. N.; Kessler, C. L.; Reichmann, W. M.; Wright, E. A.; McAlindon, T. E.; Losina, E (2008). "Joint space narrowing and KellgrenLawrence progression in knee osteoarthritis: An analytic literature synthesis". Osteoarthritis and Cartilage. 16 (8): 873–82 11) Fernandes, Linda, et al. "EULAR recommendations for the non-pharmacological core management of hip and knee osteoarthritis." Annals of the rheumatic diseases 72.7 (2013): 1125-1135. 12) Gossec, L., et al. "The role of pain and functional impairment in the decision to recommend total joint replacement in hip and knee osteoarthritis: an international cross-sectional study of 1909 patients. Report of the OARSI-

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OMERACT Task Force on total joint replacement." Osteoarthritis and Cartilage 19.2 (2011): 147-154. 13) Gossec, Laure, et al. "OARSI/OMERACT initiative to define states of severity and indication for joint replacement in hip and knee osteoarthritis. An OMERACT 10 Special Interest Group." The Journal of rheumatology 38.8 (2011): 1765-1769. 14) Hamilton, T. W., et al. "Unicompartmental knee replacement: Does the macroscopic status of the anterior cruciate ligament affect outcome?." The Knee (2016). 15) Hansen, Dane C., et al. "Robotic guidance does not improve component position or short-term outcome in medial unicompartmental knee arthroplasty." The Journal of arthroplasty 29.9 (2014): 1784-1789. 16) Hochberg, Marc C., et al. "American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee." Arthritis care & research 64.4 (2012): 465-474. 17) Jevsevar, David S. "Treatment of osteoarthritis of the knee: evidence-based guideline." Journal of the American Academy of Orthopaedic Surgeons 21.9 (2013): 571-576. 18) Johnson AJ, Costa CR, Mont MA. Do We Need Gender-specific Total Joint Arthroplasty? Clinical Orthopaedics and Related Research. 2011;469(7):18521858. doi:10.1007/s11999-011-1769-2. 19) Joseph, G. B., et al. "A reference database of cartilage 3 T MRI T2 values in knees without diagnostic evidence of cartilage degeneration: data from the osteoarthritis initiative." Osteoarthritis and Cartilage 23.6 (2015): 897-905. 20) Kellgren, J. H.; Lawrence, J. S. (1957). "Radiological assessment of osteoarthrosis". Annals of the rheumatic diseases. 16 (4): 494–502 21) Kostamo, Timothy, et al. "No difference in gender-specific hip replacement outcomes." Clinical orthopaedics and related research 467.1 (2009): 135-140. 22) Kozinn, S. C., and R. Scott. "Unicondylar knee arthroplasty." J Bone Joint Surg Am 71.1 (1989): 145-150. 23) Kremers, Hilal Maradit, et al. "The Effect of Obesity on Direct Medical Costs in Total Knee Arthroplasty." The Journal of Bone & Joint Surgery 96.9 (2014): 718724. 24) Losina, Elena, et al. "Cost-effectiveness of total knee arthroplasty in the United States: patient risk and hospital volume." Archives of internal medicine 169.12 (2009): 1113. 8— Knee Arthroplasty 2017 v2

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25) Losina, Elena, et al. "The dramatic increase in total knee replacement utilization rates in the United States cannot be fully explained by growth in population size and the obesity epidemic." The Journal of Bone & Joint Surgery 94.3 (2012): 201207. 26) McGrory, Brian J., et al. "Surgical Management of Osteoarthritis of the Knee: Evidence-based Guideline." Journal of the American Academy of Orthopaedic Surgeons 24.8 (2016): e87-e93. 27) Mofidi, Ali, et al. "Assessment of accuracy of robotically assisted unicompartmental arthroplasty." Knee Surgery, Sports Traumatology, Arthroscopy (2014): 1-8. 28) Mosier, Brian A., et al. "Management of Patellofemoral Arthritis: From Cartilage Restoration to Arthroplasty." Journal of the American Academy of Orthopaedic Surgeons 24.11 (2016): e163-e173. 29) Nair, R., G. Tripathy, and G. R. Deysine. "Computer navigation systems in unicompartmental knee arthroplasty: a systematic review." American journal of orthopedics (Belle Mead, NJ) 43.6 (2014): 256-261. 30) Nieuwenhuijse, Marc J., et al. "Appraisal of evidence base for introduction of new implants in hip and knee replacement: a systematic review of five widely used device technologies." (2014): g5133. 31) Ng, Vincent Y., et al. "Preoperative risk stratification and risk reduction for total joint reconstruction." J Bone Joint Surg Am 95.4 (2013): e19. 32) Ong, Kevin L., et al. "Hyaluronic Acid Injections in Medicare Knee Osteoarthritis Patients Are Associated With Longer Time to Knee Arthroplasty." The Journal of arthroplasty (2016). 33) Papavasiliou, A. V., et al. "Infection in knee replacements after previous injection of intra-articular steroid." Bone & Joint Journal 88.3 (2006): 321-323. 34) Piriou, Philippe, et al. "Are gender-specific femoral implants for total knee arthroplasty necessary?." The Journal of arthroplasty 29.4 (2014): 742-748. 35) Pritchett, James W. "Bicruciate-retaining total knee replacement provides satisfactory function and implant survivorship at 23 years." Clinical Orthopaedics and Related Research® 473.7 (2015): 2327-2333. 36) Song, Eun Kyoo, et al. "Comparison of Outcome and Survival after Unicompartmental Knee Arthroplasty between Navigation and Conventional Techniques with an Average 9-Year Follow-Up." The Journal of arthroplasty 31.2 (2016): 395-400.

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37) Stephens, Byron F., G. Andrew Murphy, and William M. Mihalko. "The effects of nutritional deficiencies, smoking, and systemic disease on orthopaedic outcomes." The Journal of Bone & Joint Surgery 95.23 (2013): 2152-2157. 38) Thompson, Scott AJ, et al. "Factors Associated With Poor Outcomes Following Unicompartmental Knee Arthroplasty: Redefining the “Classic” Indications for Surgery." The Journal of arthroplasty 28.9 (2013): 1561-1564. 39) Thomsen, Morten G., et al. "Indications for knee arthroplasty have remained consistent over time." Dan Med J 59 (2012): A4492. 40) Weinstein, Alexander M., et al. "Estimating the burden of total knee replacement in the United States." The Journal of Bone & Joint Surgery 95.5 (2013): 385-392. 41) Wright, Rick W., and MARS Group. "Osteoarthritis classification scales: interobserver reliability and arthroscopic correlation." J Bone Joint Surg Am 96.14 (2014): 1145-1151. 42) Zhang, W., et al. "OARSI recommendations for the management of hip and knee osteoarthritis: part III: Changes in evidence following systematic cumulative update of research published through January 2009." Osteoarthritis and Cartilage 18.4 (2010): 476-499.

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