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There are two cartilage structures, called menisci, in each knee joint. A torn meniscus can be caused by a traumatic injury or aging-related degeneration. Osteoarthritis (OA) is a type of arthritis that is caused by the breakdown and eventual loss of another type of cartilage that covers the end of bones within a joint. In people who have knee OA, a meniscal tear can easily lead to disability. This study will compare the effectiveness of two recommended treatments, surgery and physical therapy, for people with a torn meniscus and knee OA.
OA is the most common form of arthritis in the United States. Symptoms of knee OA include pain in and around the knee that typically worsens with weight-bearing activities, morning stiffness, and tenderness. A person with OA who experiences a torn meniscus--a cartilage structure within the knee that provides stability and proper weight distribution--is especially at risk for disability. Past studies have shown that arthroscopic partial meniscectomy (APM), a type of knee surgery, usually relieves symptoms and improves function in people suffering from a meniscal tear. However, the success of APM is more variable among people with already existing OA. Clinicians are also uncertain about the short- and long-term benefits, drawbacks, and indications for APM in people with OA and meniscal tears. The purpose of this study is to compare the effectiveness of two treatments, APM surgery and standard physical therapy, for people with OA and a torn meniscus.
This study will last 12 years. At the initial study visit, participants will be randomly assigned to one of two groups.
The study consists of up to 5 visits to the center:
Telephone calls: During the first 3 months of the study, all participants will receive check-up phone calls every 2 weeks, followed by quarterly phone calls for the initial 2 years in the study
Questionnaires: Participants will also complete mailed questionnaires at 6 months, and 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, and 12 years after enrollment. The questionnaires will include questions about knee pain, ability to walk, recreational activities, general health, and satisfaction with with treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical | Experimental | Participants will undergo arthroscopic partial menisectomy (APM) surgery and offered postoperative rehabilitative physical therapy. |
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| Nonoperative | Active Comparator | Participants will undergo standard physical therapy that will include strengthening and stretching sessions one to three times a week for 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arthroscopic partial menisectomy | Procedure | Arthroscopic partial meniscectomy is a surgical procedure that is performed to remove a piece of torn cartilage in the knee joint. Incisions for arthroscopy are quite small, usually about 1 centimeter each. The torn meniscus can be removed using a number of different instruments, including small shavers and scissors. |
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC Functional Status - Difference From Baseline | Scores on the physical-function subscale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) range from 0 to 100, with higher scores indicating more limitation of physical function. The primary outcome was the difference between the study groups with respect to the change in the score on the physical-function scale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) from baseline to 6 months after randomization. | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| KOOS Pain - Difference From Baseline | Scores on the pain scale of the Knee Injury and Osteoarthritis Outcome Scale (KOOS) range from 0 to 100, with higher scores indicating more pain. The secondary outcome was the difference between the study groups with respect to the change in the score on the pain scale of the Knee Injury and Osteoarthritis Outcome Scale (KOOS) from baseline to 6 months after randomization. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey N. Katz, MD, MS | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States | ||
| Brigham and Women's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22968127 | Background | Katz JN, Chaisson CE, Cole B, Guermazi A, Hunter DJ, Jones M, Levy BA, Mandl LA, Martin S, Marx RG, Safran-Norton C, Roemer FW, Skoniecki D, Solomon DH, Spindler KP, Wright J, Wright RW, Losina E. The MeTeOR trial (Meniscal Tear in Osteoarthritis Research): rationale and design features. Contemp Clin Trials. 2012 Nov;33(6):1189-96. doi: 10.1016/j.cct.2012.08.010. Epub 2012 Sep 5. | |
| 23506518 | Background | Katz JN, Brophy RH, Chaisson CE, de Chaves L, Cole BJ, Dahm DL, Donnell-Fink LA, Guermazi A, Haas AK, Jones MH, Levy BA, Mandl LA, Martin SD, Marx RG, Miniaci A, Matava MJ, Palmisano J, Reinke EK, Richardson BE, Rome BN, Safran-Norton CE, Skoniecki DJ, Solomon DH, Smith MV, Spindler KP, Stuart MJ, Wright J, Wright RW, Losina E. Surgery versus physical therapy for a meniscal tear and osteoarthritis. N Engl J Med. 2013 May 2;368(18):1675-84. doi: 10.1056/NEJMoa1301408. Epub 2013 Mar 18. |
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The Meniscal Tear in Osteoarthritis Research (MeTeOR) trial was performed in seven academic referral centers with enrollment occurring from June 2008 through August 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arthroscopic Partial Meniscectomy (APM) | Participants underwent arthroscopic partial menisectomy (APM) surgery and were offered postoperative rehabilitative physical therapy. |
| FG001 | Physical Therapy (PT) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Standard physical therapy | Other | Participants will undergo standard physical therapy that will include strengthening and stretching sessions one to three times a week for 8 weeks. This physical therapy regimen will have similar elements and goals as the postoperative intervention offered to Group 1 participants. |
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| Postoperative rehabilitative physical therapy | Other | This physical therapy is geared specifically toward rehabilitation after APM surgery. |
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| Baseline to 6 months |
| SF-36 Physical Functional Status Scale - Difference From Baseline | Scores on the physical-activity scale of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) range from 0 to 100, with higher scores indicating greater physical activity. | 6 months |
| Total Knee Replacement - Subjects Received | Number of subjects that elected to undergo Total Knee Replacement or Total Knee Arthroplasty between baseline and 60 month follow up. Intended to show the total number of participants that underwent Total Knee Replacement in the period following the initial intervention through 60 month follow up. | Baseline to 60 months |
| KOOS Pain - Mean at 60 Months | Scores on the pain scale of the Knee Injury and Osteoarthritis Outcome Scale (KOOS) range from 0 to 100, with higher scores indicating more pain. The secondary outcome was the mean KOOS pain for each of the study groups 60 months after randomization. | 60 months |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Washington University in St Louis, School of Medicine | St Louis | Missouri | 63110 | United States |
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
| 27067990 | Background | Deshpande BR, Losina E, Smith SR, Martin SD, Wright RJ, Katz JN. Association of MRI findings and expert diagnosis of symptomatic meniscal tear among middle-aged and older adults with knee pain. BMC Musculoskelet Disord. 2016 Apr 11;17:154. doi: 10.1186/s12891-016-1010-2. |
| 27296899 | Background | Tuakli-Wosornu YA, Selzer F, Losina E, Katz JN. Predictors of Exercise Adherence in Patients With Meniscal Tear and Osteoarthritis. Arch Phys Med Rehabil. 2016 Nov;97(11):1945-1952. doi: 10.1016/j.apmr.2016.05.011. Epub 2016 Jun 11. |
| 27852905 | Background | Katz JN, Wright J, Spindler KP, Mandl LA, Safran-Norton CE, Reinke EK, Levy BA, Wright RW, Jones MH, Martin SD, Marx RG, Losina E. Predictors and Outcomes of Crossover to Surgery from Physical Therapy for Meniscal Tear and Osteoarthritis: A Randomized Trial Comparing Physical Therapy and Surgery. J Bone Joint Surg Am. 2016 Nov 16;98(22):1890-1896. doi: 10.2106/JBJS.15.01466. |
| 27390312 | Background | Katz JN, Smith SR, Yang HY, Martin SD, Wright J, Donnell-Fink LA, Losina E. Value of History, Physical Examination, and Radiographic Findings in the Diagnosis of Symptomatic Meniscal Tear Among Middle-Aged Subjects With Knee Pain. Arthritis Care Res (Hoboken). 2017 Apr;69(4):484-490. doi: 10.1002/acr.22975. Epub 2017 Mar 3. |
| 28043939 | Background | MacFarlane LA, Yang H, Collins JE, Guermazi A, Jones MH, Teeple E, Xu L, Losina E, Katz JN. Associations among meniscal damage, meniscal symptoms and knee pain severity. Osteoarthritis Cartilage. 2017 Jun;25(6):850-857. doi: 10.1016/j.joca.2016.12.023. Epub 2016 Dec 30. |
| 28978308 | Background | Winter AR, Collins JE, Katz JN. The likelihood of total knee arthroplasty following arthroscopic surgery for osteoarthritis: a systematic review. BMC Musculoskelet Disord. 2017 Oct 4;18(1):408. doi: 10.1186/s12891-017-1765-0. |
| 30049269 | Background | Luc-Harkey BA, Safran-Norton CE, Mandl LA, Katz JN, Losina E. Associations among knee muscle strength, structural damage, and pain and mobility in individuals with osteoarthritis and symptomatic meniscal tear. BMC Musculoskelet Disord. 2018 Jul 27;19(1):258. doi: 10.1186/s12891-018-2182-8. |
| 30133187 | Background | MacFarlane LA, Yang H, Collins JE, Jarraya M, Guermazi A, Mandl LA, Martin SD, Wright J, Losina E, Katz JN; MeTeOR Investigator Group. Association of Changes in Effusion-Synovitis With Progression of Cartilage Damage Over Eighteen Months in Patients With Osteoarthritis and Meniscal Tear. Arthritis Rheumatol. 2019 Jan;71(1):73-81. doi: 10.1002/art.40660. Epub 2018 Nov 29. |
| 30653921 | Background | MacFarlane LA, Yang H, Collins JE, Guermazi A, Jones MH, Spindler KP, Winter AR, Losina E, Katz JN; the MeTeOR Investigator Group; Brophy RH, Cole BJ, Levy BA, Mandl LA, Martin S, Marx RG, Matava M, Safran-Norton C, Stuart M, Wright R. Influence of Baseline Magnetic Resonance Imaging Features on Outcome of Arthroscopic Meniscectomy and Physical Therapy Treatment of Meniscal Tears in Osteoarthritis. Am J Sports Med. 2019 Mar;47(3):612-619. doi: 10.1177/0363546518819444. Epub 2019 Jan 17. |
| 29726627 | Background | MacFarlane LA, Yang H, Collins JE, Guermazi A, Mandl LA, Levy BA, Marx RG, Safran-Norton CE, Losina E, Katz JN; Meniscal Tear in Osteoarthritis Research Investigator Group. Relationship Between Patient-Reported Swelling and Magnetic Resonance Imaging-Defined Effusion-Synovitis in Patients With Meniscus Tears and Knee Osteoarthritis. Arthritis Care Res (Hoboken). 2019 Mar;71(3):385-389. doi: 10.1002/acr.23592. |
| 30932360 | Background | Collins JE, Losina E, Marx RG, Guermazi A, Jarraya M, Jones MH, Levy BA, Mandl LA, Martin SD, Wright RW, Spindler KP, Katz JN; MeTeOR Investigator Group. Early Magnetic Resonance Imaging-Based Changes in Patients With Meniscal Tear and Osteoarthritis: Eighteen-Month Data From a Randomized Controlled Trial of Arthroscopic Partial Meniscectomy Versus Physical Therapy. Arthritis Care Res (Hoboken). 2020 May;72(5):630-640. doi: 10.1002/acr.23891. |
| 31429198 | Background | Katz JN, Shrestha S, Losina E, Jones MH, Marx RG, Mandl LA, Levy BA, MacFarlane LA, Spindler KP, Silva GS; METEOR Investigators; Collins JE. Five-Year Outcome of Operative and Nonoperative Management of Meniscal Tear in Persons Older Than Forty-Five Years. Arthritis Rheumatol. 2020 Feb;72(2):273-281. doi: 10.1002/art.41082. Epub 2019 Dec 15. |
| 35245416 | Derived | Collins JE, Shrestha S, Losina E, Marx RG, Guermazi A, Jarraya M, Jones MH, Levy BA, Mandl LA, Williams EE, Wright RW, Spindler KP, Katz JN; METEOR Investigator Group. Five-Year Structural Changes in the Knee Among Patients With Meniscal Tear and Osteoarthritis: Data From a Randomized Controlled Trial of Arthroscopic Partial Meniscectomy Versus Physical Therapy. Arthritis Rheumatol. 2022 Aug;74(8):1333-1342. doi: 10.1002/art.42105. Epub 2022 Jun 28. |
| 34606692 | Derived | Katz JN, Collins JE, Jones M, Spindler KP, Marx RG, Mandl LA, Levy BA, Wright R, Jarraya M, Guermazi A, MacFarlane LA, Losina E, Chang Y. Association Between Structural Change Over Eighteen Months and Subsequent Symptom Change in Middle-Aged Patients Treated for Meniscal Tear. Arthritis Care Res (Hoboken). 2023 Feb;75(2):340-347. doi: 10.1002/acr.24796. Epub 2022 Oct 21. |
| 33650303 | Derived | MacFarlane LA, Yang H, Collins JE, Brophy RH, Cole BJ, Spindler KP, Guermazi A, Jones MH, Mandl LA, Martin S, Marx RG, Levy BA, Stuart M, Safran-Norton C, Wright J, Wright RW, Losina E, Katz JN. Association Between Baseline Meniscal Symptoms and Outcomes of Operative and Nonoperative Treatment of Meniscal Tear in Patients With Osteoarthritis. Arthritis Care Res (Hoboken). 2022 Aug;74(8):1384-1390. doi: 10.1002/acr.24588. Epub 2022 May 6. |
Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
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Analysis was completed on the 330 active participants in the study at 6 months.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arthroscopic Partial Meniscectomy | Participants will undergo arthroscopic partial menisectomy (APM) surgery and offered postoperative rehabilitative physical therapy. |
| BG001 | Physical Therapy | Participants will undergo standard physical therapy that will include strengthening and stretching sessions one to three times a week for 8 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Index Knee | Number | participants |
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| Mean Body-Mass Index | The body-mass index is the weight in kilograms divided by the square of the height in meters. | Mean | Standard Deviation | kg/m^2 |
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| WOMAC physical-function score | Scores on the physical-function subscale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) range from 0 to 100, with higher scores indicating more limitation of physical function. | Mean | Standard Deviation | Units on a scale |
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| KOOS pain score | Scores on the pain scale of the Knee Injury and Osteoarthritis Outcome Scale (KOOS) range from 0 to 100, with higher scores indicating more pain. | Mean | Standard Deviation | Units on a scale |
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| Mental Health Index 5 score | Scores on the Mental Health Index 5 range from 0 to 100, with higher scores indicating better mental health. | Mean | Standard Deviation | Units on a scale |
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| SF-36 Physical Activity score | Scores on the physical-activity scale of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) range from 0 to 100, with higher scores indicating greater physical activity. | Mean | Standard Deviation | Units on a scale |
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| Kellgren-Lawrence grade | A Kellgren-Lawrence grade of 0 (no osteophytes or joint-space narrowing) indicates no osteoarthritis, a grade of 1 (questionable osteophyte) indicates possible osteoarthritis; a grade of 2 (definite osteophyte, no joint-space narrowing) indicates mild osteoarthritis, a grade of 3 (less than or equal to 50% joint-space narrowing) indicates moderate osteoarthritis, and a grade of 4 (greater than 50% joint-space narrowing) indicates severe osteoarthritis. Total number of participants analyzed does not equal the total number of participants due to missing data. | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | WOMAC Functional Status - Difference From Baseline | Scores on the physical-function subscale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) range from 0 to 100, with higher scores indicating more limitation of physical function. The primary outcome was the difference between the study groups with respect to the change in the score on the physical-function scale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) from baseline to 6 months after randomization. | Posted | Mean | 95% Confidence Interval | Score | Baseline and 6 months |
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| Secondary | KOOS Pain - Difference From Baseline | Scores on the pain scale of the Knee Injury and Osteoarthritis Outcome Scale (KOOS) range from 0 to 100, with higher scores indicating more pain. The secondary outcome was the difference between the study groups with respect to the change in the score on the pain scale of the Knee Injury and Osteoarthritis Outcome Scale (KOOS) from baseline to 6 months after randomization. | Posted | Mean | 95% Confidence Interval | Score | Baseline to 6 months |
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| Secondary | SF-36 Physical Functional Status Scale - Difference From Baseline | Scores on the physical-activity scale of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) range from 0 to 100, with higher scores indicating greater physical activity. | Posted | Mean | 95% Confidence Interval | Score | 6 months |
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| Secondary | Total Knee Replacement - Subjects Received | Number of subjects that elected to undergo Total Knee Replacement or Total Knee Arthroplasty between baseline and 60 month follow up. Intended to show the total number of participants that underwent Total Knee Replacement in the period following the initial intervention through 60 month follow up. | Posted | Count of Participants | Participants | Baseline to 60 months |
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| Secondary | KOOS Pain - Mean at 60 Months | Scores on the pain scale of the Knee Injury and Osteoarthritis Outcome Scale (KOOS) range from 0 to 100, with higher scores indicating more pain. The secondary outcome was the mean KOOS pain for each of the study groups 60 months after randomization. | Posted | Mean | 95% Confidence Interval | score on a scale | 60 months |
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60 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arthroscopic Partial Meniscectomy | Participants underwent arthroscopic partial menisectomy (APM) surgery and were offered postoperative rehabilitative physical therapy. | 1 | 174 | 3 | 174 | 15 | 174 |
| EG001 | Physical Therapy | Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks. | 1 | 177 | 2 | 177 | 13 | 177 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiovascular | Cardiac disorders | Systematic Assessment |
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| Hypoxemia | Vascular disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muskuloskeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pain in the back, hip, or foot | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Cardiovascular | Cardiac disorders | Systematic Assessment |
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Surgical randomized controlled trials present methodological challenges, including crossover from one group to the other.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey N. Katz, MD, MSc | The Brigham and Women's Hospital | 617-732-5338 | jnkatz@bwh.harvard.edu |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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