Trial Outcomes & Findings for Comparing Surgery Versus Standard Physical Therapy in Treating People With a Meniscal Tear and Osteoarthritis (NCT NCT00597012)

NCT ID: NCT00597012

Last Updated: 2026-05-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

351 participants

Primary outcome timeframe

Baseline and 6 months

Results posted on

2026-05-18

Participant Flow

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

Participant milestones

Participant milestones
Measure
Arthroscopic Partial Meniscectomy (APM)
Participants underwent arthroscopic partial menisectomy (APM) surgery and were offered postoperative rehabilitative physical therapy.
Physical Therapy (PT)
Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
Overall Study
STARTED
174
177
Overall Study
COMPLETED
161
169
Overall Study
NOT COMPLETED
13
8

Reasons for withdrawal

Reasons for withdrawal
Measure
Arthroscopic Partial Meniscectomy (APM)
Participants underwent arthroscopic partial menisectomy (APM) surgery and were offered postoperative rehabilitative physical therapy.
Physical Therapy (PT)
Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
Overall Study
Death
1
1
Overall Study
Underwent Total Knee Replacement (TKR)
3
1
Overall Study
Withdrawal by Subject
7
4
Overall Study
Ineligible
2
0
Overall Study
Lost to Follow-up
0
2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Arthroscopic Partial Meniscectomy
n=161 Participants
Participants will undergo arthroscopic partial menisectomy (APM) surgery and offered postoperative rehabilitative physical therapy.
Physical Therapy
n=169 Participants
Participants will undergo standard physical therapy that will include strengthening and stretching sessions one to three times a week for 8 weeks.
Total
n=660 Participants
Total of all reporting groups
Age, Customized
59.0 years
STANDARD_DEVIATION 7.9 • n=161 Participants
57.8 years
STANDARD_DEVIATION 6.8 • n=169 Participants
58.4 years
STANDARD_DEVIATION 7.3 • n=330 Participants
Sex: Female, Male
Female
90 Participants
n=161 Participants
97 Participants
n=169 Participants
187 Participants
n=330 Participants
Sex: Female, Male
Male
71 Participants
n=161 Participants
72 Participants
n=169 Participants
143 Participants
n=330 Participants
Race/Ethnicity, Customized
White
138 participants
n=161 Participants
142 participants
n=169 Participants
280 participants
n=330 Participants
Race/Ethnicity, Customized
Black or African American
15 participants
n=161 Participants
17 participants
n=169 Participants
32 participants
n=330 Participants
Race/Ethnicity, Customized
Hispanic
2 participants
n=161 Participants
5 participants
n=169 Participants
7 participants
n=330 Participants
Race/Ethnicity, Customized
Other
6 participants
n=161 Participants
5 participants
n=169 Participants
11 participants
n=330 Participants
Index Knee
Right
70 participants
n=161 Participants
68 participants
n=169 Participants
138 participants
n=330 Participants
Index Knee
Left
91 participants
n=161 Participants
101 participants
n=169 Participants
192 participants
n=330 Participants
Mean Body-Mass Index
30.0 kg/m^2
STANDARD_DEVIATION 6.1 • n=161 Participants
30.0 kg/m^2
STANDARD_DEVIATION 6.1 • n=169 Participants
30.0 kg/m^2
STANDARD_DEVIATION 6.1 • n=330 Participants
WOMAC physical-function score
37.1 Units on a scale
STANDARD_DEVIATION 17.9 • n=161 Participants
37.5 Units on a scale
STANDARD_DEVIATION 18.3 • n=169 Participants
37.3 Units on a scale
STANDARD_DEVIATION 18.1 • n=330 Participants
KOOS pain score
46.0 Units on a scale
STANDARD_DEVIATION 15.5 • n=161 Participants
47.2 Units on a scale
STANDARD_DEVIATION 16.4 • n=169 Participants
46.6 Units on a scale
STANDARD_DEVIATION 16.0 • n=330 Participants
Mental Health Index 5 score
74.8 Units on a scale
STANDARD_DEVIATION 12.9 • n=161 Participants
74.0 Units on a scale
STANDARD_DEVIATION 13.9 • n=169 Participants
74.4 Units on a scale
STANDARD_DEVIATION 13.5 • n=330 Participants
SF-36 Physical Activity score
44.3 Units on a scale
STANDARD_DEVIATION 23.7 • n=161 Participants
43.3 Units on a scale
STANDARD_DEVIATION 23.3 • n=169 Participants
43.8 Units on a scale
STANDARD_DEVIATION 23.5 • n=330 Participants
Kellgren-Lawrence grade
0
34 participants
n=161 Participants
36 participants
n=169 Participants
70 participants
n=330 Participants
Kellgren-Lawrence grade
1
26 participants
n=161 Participants
35 participants
n=169 Participants
61 participants
n=330 Participants
Kellgren-Lawrence grade
2
37 participants
n=161 Participants
39 participants
n=169 Participants
76 participants
n=330 Participants
Kellgren-Lawrence grade
3
45 participants
n=161 Participants
39 participants
n=169 Participants
84 participants
n=330 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months

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.

Outcome measures

Outcome measures
Measure
Physical Therapy
n=169 Participants
Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
Arthroscopic Partial Meniscectomy
n=161 Participants
Participants underwent arthroscopic partial menisectomy (APM) surgery and were referred for postoperative rehabilitative physical therapy.
WOMAC Functional Status - Difference From Baseline
18.5 Score
Interval 15.6 to 21.5
20.9 Score
Interval 17.9 to 23.9

SECONDARY outcome

Timeframe: Baseline to 6 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 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.

Outcome measures

Outcome measures
Measure
Physical Therapy
n=169 Participants
Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
Arthroscopic Partial Meniscectomy
n=161 Participants
Participants underwent arthroscopic partial menisectomy (APM) surgery and were referred for postoperative rehabilitative physical therapy.
KOOS Pain - Difference From Baseline
21.3 Score
Interval 18.4 to 24.2
24.2 Score
Interval 21.3 to 27.1

SECONDARY outcome

Timeframe: 6 months

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.

Outcome measures

Outcome measures
Measure
Physical Therapy
n=169 Participants
Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
Arthroscopic Partial Meniscectomy
n=161 Participants
Participants underwent arthroscopic partial menisectomy (APM) surgery and were referred for postoperative rehabilitative physical therapy.
SF-36 Physical Functional Status Scale - Difference From Baseline
23.1 Score
Interval 19.2 to 27.0
24.2 Score
Interval 20.3 to 28.0

SECONDARY outcome

Timeframe: Baseline to 60 months

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.

Outcome measures

Outcome measures
Measure
Physical Therapy
n=169 Participants
Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
Arthroscopic Partial Meniscectomy
n=161 Participants
Participants underwent arthroscopic partial menisectomy (APM) surgery and were referred for postoperative rehabilitative physical therapy.
Total Knee Replacement - Subjects Received
9 Participants
16 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Physical Therapy
n=169 Participants
Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
Arthroscopic Partial Meniscectomy
n=161 Participants
Participants underwent arthroscopic partial menisectomy (APM) surgery and were referred for postoperative rehabilitative physical therapy.
KOOS Pain - Mean at 60 Months
19.4 score on a scale
Interval 16.7 to 22.1
18.2 score on a scale
Interval 15.4 to 20.9

Adverse Events

Arthroscopic Partial Meniscectomy

Serious events: 3 serious events
Other events: 15 other events
Deaths: 1 deaths

Physical Therapy

Serious events: 2 serious events
Other events: 13 other events
Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure
Arthroscopic Partial Meniscectomy
n=174 participants at risk
Participants underwent arthroscopic partial menisectomy (APM) surgery and were offered postoperative rehabilitative physical therapy.
Physical Therapy
n=177 participants at risk
Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
Cardiac disorders
Cardiovascular
1.1%
2/174 • Number of events 2 • 60 months
1.1%
2/177 • Number of events 2 • 60 months
Vascular disorders
Hypoxemia
0.57%
1/174 • Number of events 1 • 60 months
0.00%
0/177 • 60 months

Other adverse events

Other adverse events
Measure
Arthroscopic Partial Meniscectomy
n=174 participants at risk
Participants underwent arthroscopic partial menisectomy (APM) surgery and were offered postoperative rehabilitative physical therapy.
Physical Therapy
n=177 participants at risk
Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
Musculoskeletal and connective tissue disorders
Muskuloskeletal
4.0%
7/174 • Number of events 7 • 60 months
3.4%
6/177 • Number of events 6 • 60 months
Musculoskeletal and connective tissue disorders
Pain in the back, hip, or foot
1.1%
2/174 • Number of events 2 • 60 months
2.3%
4/177 • Number of events 4 • 60 months
Cardiac disorders
Cardiovascular
3.4%
6/174 • Number of events 6 • 60 months
1.7%
3/177 • Number of events 3 • 60 months

Additional Information

Jeffrey N. Katz, MD, MSc

The Brigham and Women's Hospital

Phone: 617-732-5338

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place