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Brief Summary

GUIDELINE TITLE

Total knee replacement.

BIBLIOGRAPHIC SOURCE(S)

  • National Institutes of Health (NIH) Consensus Development Panel on Total Knee Replacement. National Institutes of Health consensus statement on total knee replacement December 8-10, 2003. Final statement. Rockville (MD): U.S. Department of Health and Human Services (DHHS); 2004 Feb 17. 18 p.

GUIDELINE STATUS

This is the current release of the guideline.

** REGULATORY ALERT **

FDA WARNING/REGULATORY ALERT

Note from the National Guideline Clearinghouse: This guideline references a drug(s) for which important revised regulatory and/or warning information has been released.

  • February 28, 2008, Heparin Sodium Injection: The U.S. Food and Drug Administration (FDA) informed the public that Baxter Healthcare Corporation has voluntarily recalled all of their multi-dose and single-use vials of heparin sodium for injection and their heparin lock flush solutions. Alternate heparin manufacturers are expected to be able to increase heparin production sufficiently to supply the U.S. market. There have been reports of serious adverse events including allergic or hypersensitivity-type reactions, with symptoms of oral swelling, nausea, vomiting, sweating, shortness of breath, and cases of severe hypotension.

BRIEF SUMMARY CONTENT

 ** REGULATORY ALERT **
 RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

 Go to the Complete Summary

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

Primary total knee replacement (TKR) is most commonly performed for knee joint failure caused by osteoarthritis (OA); other indications include rheumatoid arthritis (RA), juvenile rheumatoid arthritis, osteonecrosis, and other types of inflammatory arthritis. The aims of TKR are relief of pain and improvement in function. Candidates for elective TKR should have radiographic evidence of joint damage, moderate-to-severe persistent pain not adequately relieved by an extended course of nonsurgical management, and clinically significant functional limitation resulting in diminished quality of life.

The success of primary TKR in most patients is strongly supported by more than 20 years of follow-up data. There appears to be rapid and substantial improvement in the patient’s pain, functional status, and overall health-related quality of life in about 90 percent of patients; about 85 percent of patients are satisfied with the results of surgery.

Short-term outcomes, as documented by functional outcome scales, are generally substantially improved after TKR. Functional outcome is improved after TKR for people across the spectrum of disability status. In general, prostheses are durable, but failure does occur.

Age younger than 55 at the time of TKR, male gender, diagnosis of osteoarthritis, obesity, and presence of comorbid conditions are risk factors for revision.

Factors related to a surgeon’s case volume, technique, and choice of prosthesis may have important influences on surgical outcomes. One of the clearest associations with better outcomes appears to be the procedure volume of the individual surgeon and the hospital.

Technical factors in performing surgery may influence both the short- and long-term success rate. Proper alignment of the prosthesis appears to be critical. Many design features, such as use of mobile bearings or designs sparing cruciate ligaments, have theoretical advantages, but durability and success rates appear roughly similar with most commonly used designs.

There is consensus regarding the following perioperative interventions that improve TKR outcomes: systemic antibiotic prophylaxis, aggressive postoperative pain management, perioperative risk assessment and management of medical conditions, and preoperative education.

The effectiveness of anticoagulation for the prevention of pulmonary emboli is unclear. There are insufficient data to support specific perioperative rehabilitation strategies, methods to reduce postoperative anemia, postoperative physical activity recommendations, and the site of post-acute care.

Revision TKR is done to alleviate pain and improve function. Fracture or dislocation of the patella, instability of the components or aseptic loosening, infection, and periprosthetic fractures are common reasons for total knee revision. A painful knee without an identifiable cause is a controversial indication. Contraindications for revision TKR include persistent infection, poor bone quality, highly limited quadriceps or extensor function, poor skin coverage, and poor vascular status. Results are not as good as with primary TKR; outcomes are better for aseptic loosening than for infections. When infection is involved, successful results occur with a two-stage revision. Failed revisions require a salvage procedure (resection of arthroplasty, arthrodesis, or amputation), with inferior results compared with revision TKR.

There is clear evidence of racial/ethnic and gender disparities in the provision of TKR in the United States. Racial or ethnic differences in the provision of care are not limited to joint replacements. The limited role of economic and other access factors in these racial or ethnic disparities can be demonstrated by significant differences in the rate of procedures in the Veterans Administration (VA) system, where cost and access are assumed equivalent across race or ethnic groups.

Patients’ acceptance of physician recommendations varies greatly. Among persons with a potential need for TKR, only 12.7 percent of women and 8.8 percent of men were "definitely willing" to have the procedure. The interaction between the patient and physician affects the final recommendations and the patient’s acceptance of those recommendations. Physicians’ beliefs about their patients, the limited familiarity with these procedures in minority communities, patients’ mistrust of the health care system, and personal beliefs about the most effective treatment of joint problems may all have a role in these racial or ethnic disparities.

CLINICAL ALGORITHM(S)

None provided

EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is not specifically stated for each recommendation.

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

  • National Institutes of Health (NIH) Consensus Development Panel on Total Knee Replacement. National Institutes of Health consensus statement on total knee replacement December 8-10, 2003. Final statement. Rockville (MD): U.S. Department of Health and Human Services (DHHS); 2004 Feb 17. 18 p.

ADAPTATION

Not applicable: The guideline was not adapted from another source.

DATE RELEASED

2004 Feb 17

GUIDELINE DEVELOPER(S)

National Institutes of Health (NIH) Consensus Development Panel on Total Knee Replacement - Independent Expert Panel

SOURCE(S) OF FUNDING

United States Government

GUIDELINE COMMITTEE

National Institutes of Health (NIH) Consensus Development Panel

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Panel Members: E. Anthony Rankin, MD (Chair), Chief of Orthopaedic Surgery, Providence Hospital, Clinical Professor of Orthopaedic Surgery, Howard University, Washington, District of Columbia; Graciela S. Alarcón, MD, MPH, Jane Knight Lowe Chair of Medicine in Rheumatology, Division of Clinical Immunology and Rheumatology, University of Alabama School of Medicine, Birmingham, Alabama; Rowland W. Chang, MD, MPH, Professor, Departments of Preventive Medicine, Medicine, and Physical Medicine and Rehabilitation, Northwestern University Feinberg School of Medicine, Chicago, Illinois; Leo M. Cooney, Jr., MD, Professor of Medicine, Division of Geriatrics, Department of Internal Medicine, Yale University School of Medicine, Yale-New Haven Hospital, New Haven, Connecticut; Linda S. Costley, Covington, Georgia; Anthony Delitto, PhD, PT, FAPTA, Associate Professor and Chair, Department of Physical Therapy, University of Pittsburgh, Pittsburgh, Pennsylvania; Richard A. Deyo, MD, MPH, Professor, Departments of Medicine and Health Services, University of Washington School of Medicine, Seattle, Washington; Sue Karen Donaldson, PhD, RN, FAAN, Professor of Physiology, School of Medicine, Professor of Nursing, School of Nursing, Johns Hopkins University, Baltimore, Maryland; Marc C. Hochberg, MD, MPH, Professor of Medicine, Head, Division of Rheumatology and Clinical Immunology, Department of Medicine, University of Maryland School of Medicine, Baltimore, Maryland; Catherine H. MacLean, MD, PhD, Assistant Professor, Division of Rheumatology, Geffen School of Medicine, University of California, Los Angeles, Natural Scientist, RAND Health, Los Angeles, California; Edward H. Yelin, PhD, Professor of Medicine and Health Policy, Division of Rheumatology, Department of Medicine, University of California, San Francisco, San Francisco, California

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Panelists may not have real or apparent conflicts of interest. If they do have conflicts, they are eliminated from consideration. Panelists sign a statement attesting to the absence of real or apparent conflicts of interest.

GUIDELINE STATUS

This is the current release of the guideline.

GUIDELINE AVAILABILITY

Electronic copies: Available from the National Institutes of Health (NIH) Consensus Development Conference Program Web site.

Print copies: Available from the NIH Consensus Development Program Information Center, PO Box 2577, Kensington, MD 20891; Toll free phone (in U.S.), 1-888-NIH-CONSENSUS (1-888-644-2667); autofax (in U.S.), 1-888-NIH-CONSENSUS (1-888-644-2667); e-mail: consensus_statements@mail.nih.gov.

AVAILABILITY OF COMPANION DOCUMENTS

PATIENT RESOURCES

None available

NGC STATUS

This NGC summary was completed by ECRI on September 15, 2004. This summary was updated by ECRI Institute on June 22, 2007 following the U.S. Food and Drug Administration (FDA) advisory on heparin sodium injection. This summary was updated by ECRI Institute on March 14, 2008 following the updated FDA advisory on heparin sodium injection.

COPYRIGHT STATEMENT

No copyright restrictions apply.

DISCLAIMER

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