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Comparing Surgery Versus Standard Physical Therapy in Treating People With a Meniscal Tear and Osteoarthritis

Partial Meniscectomy Versus Nonoperative Management in Meniscal Tear With OA: A Randomized Controlled Trial (MeTeOR)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00597012
Enrollment
351
Registered
2008-01-17
Start date
2008-05-01
Completion date
2025-12-01
Last updated
2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

Meniscal Tear, Osteoarthritis, Arthroscopic Partial Meniscectomy, Physical Therapy, Total Knee Arthroplasty, Total Knee Replacement

Brief summary

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.

Detailed description

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. * Group 1 participants will undergo APM surgery at a time that is convenient for the participant and surgeon. After surgery, participants will be referred for rehabilitative physical therapy to regain strength and flexibility of the knee. For participants who choose to do physical therapy, the duration of treatment will depend on individual progress. * Group 2 participants will receive standard physical therapy to increase strength and flexibility of the knee. This will include one to three weekly exercise sessions over an 8-week period. The study consists of up to 5 visits to the center: * Visit 1, the enrollment visit: sign the consent form, fill out a questionnaire, have a physical examination of the knee and find out your treatment group (surgery or physical therapy * Visit 2, at 3 months after enrollment: Fill out a questionnaire and have a physical examination of the knee * Visit 3, at 18 months: Fill out a questionnaire, have an MRI of the knee (if eligible) and xrays of both knees * Visit 4, at 5 years: Fill out a questionnaire, have an MRI of the knee (if eligible) and xrays of both knees * Visit 5, at 12 years: Fill out a questionnaire, have a physical examination of the knee, have an MRI of the knee (if eligible) and xrays of both knees 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.

Interventions

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.

OTHERStandard physical therapy

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.

OTHERPostoperative rehabilitative physical therapy

This physical therapy is geared specifically toward rehabilitation after APM surgery.

Sponsors

Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* OA symptoms lasting at least 1 month and managed with medications, activity limitations, and/or physical therapy * At least one symptom consistent with a torn meniscus. Symptoms may include clicking, catching, popping, giving way, pain with pivot or torque, episodic pain, and/or pain that is acute and localized to one joint line. * Available knee X-ray (within 6 months) and MRI (within 3 years) * Evidence of osteophyte formation or cartilage fissure, tear, or loss on a knee MRI OR plain radiographic evidence of osteophyte formation or joint space narrowing * Evidence of a meniscal tear (tear extending to surface of meniscus) on a knee MRI * Willingness to undergo random assignment and sign an informed consent

Exclusion criteria

* Chronically locked knee * Kellgren-Lawrence Grade IV status, indicating advanced OA and usually the need for total knee replacement * Contraindication to MRI * Radiographic chondrocalcinosis (a condition in which there are deposits of calcium pyrophosphate dihydrate \[CPPD\] crystals in one or more joints that eventually result in damage to the affected joints) AND acute symptomatic pseudogout * Inflammatory diseases (e.g., rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, gout, pseudogout) * Injection with viscosupplementation in the affected knee in the 4 weeks before study entry * Any medical contraindications to surgery or physical therapy * Both knees are symptomatic for meniscal tears and a candidate for bilateral APMs * Prior surgery on an affected knee * Pregnancy or possible pregnancy * Claim filed for worker's compensation * Unable or unwilling to give informed consent * Unable or unwilling to attend physical therapy sessions at designated locations or in the community

Design outcomes

Primary

MeasureTime frameDescription
WOMAC Functional Status - Difference From BaselineBaseline and 6 monthsScores 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.

Secondary

MeasureTime frameDescription
KOOS Pain - Difference From BaselineBaseline to 6 monthsScores 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.
SF-36 Physical Functional Status Scale - Difference From Baseline6 monthsScores 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.
Total Knee Replacement - Subjects ReceivedBaseline to 60 monthsNumber 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.
KOOS Pain - Mean at 60 Months60 monthsScores 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJeffrey N. Katz, MD, MS

Brigham and Women's Hospital

Participant flow

Recruitment details

The Meniscal Tear in Osteoarthritis Research (MeTeOR) trial was performed in seven academic referral centers with enrollment occurring from June 2008 through August 2011.

Participants by arm

ArmCount
Arthroscopic Partial Meniscectomy
Participants will undergo arthroscopic partial menisectomy (APM) surgery and offered postoperative rehabilitative physical therapy.
161
Physical Therapy
Participants will undergo standard physical therapy that will include strengthening and stretching sessions one to three times a week for 8 weeks.
169
Total330

Baseline characteristics

CharacteristicArthroscopic Partial MeniscectomyPhysical TherapyTotal
Age, Customized59.0 years
STANDARD_DEVIATION 7.9
57.8 years
STANDARD_DEVIATION 6.8
58.4 years
STANDARD_DEVIATION 7.3
Index Knee
Left
91 participants101 participants192 participants
Index Knee
Right
70 participants68 participants138 participants
Kellgren-Lawrence grade
0
34 participants36 participants70 participants
Kellgren-Lawrence grade
1
26 participants35 participants61 participants
Kellgren-Lawrence grade
2
37 participants39 participants76 participants
Kellgren-Lawrence grade
3
45 participants39 participants84 participants
KOOS pain score46.0 Units on a scale
STANDARD_DEVIATION 15.5
47.2 Units on a scale
STANDARD_DEVIATION 16.4
46.6 Units on a scale
STANDARD_DEVIATION 16
Mean Body-Mass Index30.0 kg/m^2
STANDARD_DEVIATION 6.1
30.0 kg/m^2
STANDARD_DEVIATION 6.1
30.0 kg/m^2
STANDARD_DEVIATION 6.1
Mental Health Index 5 score74.8 Units on a scale
STANDARD_DEVIATION 12.9
74.0 Units on a scale
STANDARD_DEVIATION 13.9
74.4 Units on a scale
STANDARD_DEVIATION 13.5
Race/Ethnicity, Customized
Black or African American
15 participants17 participants32 participants
Race/Ethnicity, Customized
Hispanic
2 participants5 participants7 participants
Race/Ethnicity, Customized
Other
6 participants5 participants11 participants
Race/Ethnicity, Customized
White
138 participants142 participants280 participants
Sex: Female, Male
Female
90 Participants97 Participants187 Participants
Sex: Female, Male
Male
71 Participants72 Participants143 Participants
SF-36 Physical Activity score44.3 Units on a scale
STANDARD_DEVIATION 23.7
43.3 Units on a scale
STANDARD_DEVIATION 23.3
43.8 Units on a scale
STANDARD_DEVIATION 23.5
WOMAC physical-function score37.1 Units on a scale
STANDARD_DEVIATION 17.9
37.5 Units on a scale
STANDARD_DEVIATION 18.3
37.3 Units on a scale
STANDARD_DEVIATION 18.1

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
1 / 1741 / 177
other
Total, other adverse events
15 / 17413 / 177
serious
Total, serious adverse events
3 / 1742 / 177

Outcome results

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.

Time frame: Baseline and 6 months

ArmMeasureValue (MEAN)
Arthroscopic Partial MeniscectomyWOMAC Functional Status - Difference From Baseline20.9 Score
Physical TherapyWOMAC Functional Status - Difference From Baseline18.5 Score
Comparison: The primary analysis was implemented with an analysis of covariance with changes in the WOMAC physical-function score from baseline to 6 months as the dependent variable, treatment as the independent variable of interest, and study site as a covariate.~The primary analysis used a modified intention-to-treat approach in which patients who did not withdraw from the study were evaluated in the group to which they were randomly assigned.p-value: 0.2695% CI: [-1.8, 6.5]ANCOVA
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.

Time frame: Baseline to 6 months

ArmMeasureValue (MEAN)
Arthroscopic Partial MeniscectomyKOOS Pain - Difference From Baseline24.2 Score
Physical TherapyKOOS Pain - Difference From Baseline21.3 Score
p-value: 0.1695% CI: [-1.2, 7]ANCOVA
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.

Time frame: 60 months

ArmMeasureValue (MEAN)
Arthroscopic Partial MeniscectomyKOOS Pain - Mean at 60 Months18.2 score on a scale
Physical TherapyKOOS Pain - Mean at 60 Months19.4 score on a scale
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.

Time frame: 6 months

ArmMeasureValue (MEAN)
Arthroscopic Partial MeniscectomySF-36 Physical Functional Status Scale - Difference From Baseline24.2 Score
Physical TherapySF-36 Physical Functional Status Scale - Difference From Baseline23.1 Score
p-value: 0.6895% CI: [-4.4, 6.6]ANCOVA
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.

Time frame: Baseline to 60 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Arthroscopic Partial MeniscectomyTotal Knee Replacement - Subjects Received16 Participants
Physical TherapyTotal Knee Replacement - Subjects Received9 Participants

Source: ClinicalTrials.gov · Data processed: May 19, 2026