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Trial record 1 of 2 for:    23506518 [PUBMED-IDS]
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Comparing Knee Cartilage Surgery Versus Standard Physical Therapy in Treating People With a Meniscal Tear and Osteoarthritis

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ClinicalTrials.gov Identifier: NCT00597012
Recruitment Status : Unknown
Verified January 2017 by Jeffrey Neil Katz, MD, Brigham and Women's Hospital.
Recruitment status was:  Active, not recruiting
First Posted : January 17, 2008
Results First Posted : January 27, 2014
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
Jeffrey Neil Katz, MD, Brigham and Women's Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Osteoarthritis
Interventions Procedure: Arthroscopic partial menisectomy
Other: Standard physical therapy
Other: Postoperative rehabilitative physical therapy
Enrollment 351
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.
Pre-assignment Details  
Arm/Group Title Arthroscopic Partial Meniscectomy (APM) Physical Therapy (PT)
Hide Arm/Group Description Participants underwent arthroscopic partial menisectomy (APM) surgery and were offered postoperative rehabilitative physical therapy. Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
Period Title: Overall Study
Started 174 177
Completed 161 169
Not Completed 13 8
Reason Not Completed
Death             1             1
Underwent Total Knee Replacement (TKR)             3             1
Withdrawal by Subject             7             4
Ineligible             2             0
Lost to Follow-up             0             2
Arm/Group Title Arthroscopic Partial Meniscectomy Physical Therapy Total
Hide Arm/Group Description Participants will undergo arthroscopic partial menisectomy (APM) surgery and offered postoperative rehabilitative physical therapy. Participants will undergo standard physical therapy that will include strengthening and stretching sessions one to three times a week for 8 weeks. Total of all reporting groups
Overall Number of Baseline Participants 161 169 330
Hide Baseline Analysis Population Description
Analysis was completed on the 330 active participants in the study at 6 months.
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 161 participants 169 participants 330 participants
59.0  (7.9) 57.8  (6.8) 58.4  (7.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 161 participants 169 participants 330 participants
Female
90
  55.9%
97
  57.4%
187
  56.7%
Male
71
  44.1%
72
  42.6%
143
  43.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 161 participants 169 participants 330 participants
White 138 142 280
Black or African American 15 17 32
Hispanic 2 5 7
Other 6 5 11
Index Knee  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 161 participants 169 participants 330 participants
Right 70 68 138
Left 91 101 192
Mean Body-Mass Index   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 161 participants 169 participants 330 participants
30.0  (6.1) 30.0  (6.1) 30.0  (6.1)
[1]
Measure Description: The body-mass index is the weight in kilograms divided by the square of the height in meters.
WOMAC physical-function score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 161 participants 169 participants 330 participants
37.1  (17.9) 37.5  (18.3) 37.3  (18.1)
[1]
Measure Description: 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.
KOOS pain score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 161 participants 169 participants 330 participants
46.0  (15.5) 47.2  (16.4) 46.6  (16.0)
[1]
Measure Description: 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.
Mental Health Index 5 score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 161 participants 169 participants 330 participants
74.8  (12.9) 74.0  (13.9) 74.4  (13.5)
[1]
Measure Description: Scores on the Mental Health Index 5 range from 0 to 100, with higher scores indicating better mental health.
SF-36 Physical Activity score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 161 participants 169 participants 330 participants
44.3  (23.7) 43.3  (23.3) 43.8  (23.5)
[1]
Measure Description: 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.
Kellgren-Lawrence grade   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 161 participants 169 participants 330 participants
0 34 36 70
1 26 35 61
2 37 39 76
3 45 39 84
[1]
Measure Description:

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.

1.Primary Outcome
Title WOMAC Functional Status - Difference From Baseline
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arthroscopic Partial Meniscectomy Physical Therapy
Hide Arm/Group Description:
Participants underwent arthroscopic partial menisectomy (APM) surgery and were referred for postoperative rehabilitative physical therapy.
Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
Overall Number of Participants Analyzed 161 169
Mean (95% Confidence Interval)
Unit of Measure: Score
20.9
(17.9 to 23.9)
18.5
(15.6 to 21.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arthroscopic Partial Meniscectomy, Physical Therapy
Comments

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.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.4
Confidence Interval (2-Sided) 95%
-1.8 to 6.5
Estimation Comments [Not Specified]
2.Secondary Outcome
Title KOOS Pain - Difference From Baseline
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arthroscopic Partial Meniscectomy Physical Therapy
Hide Arm/Group Description:
Participants underwent arthroscopic partial menisectomy (APM) surgery and were referred for postoperative rehabilitative physical therapy.
Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
Overall Number of Participants Analyzed 161 169
Mean (95% Confidence Interval)
Unit of Measure: Score
24.2
(21.3 to 27.1)
21.3
(18.4 to 24.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arthroscopic Partial Meniscectomy, Physical Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.9
Confidence Interval (2-Sided) 95%
-1.2 to 7.0
Estimation Comments [Not Specified]
3.Secondary Outcome
Title SF-36 Physical Functional Status Scale - Difference From Baseline
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arthroscopic Partial Meniscectomy Physical Therapy
Hide Arm/Group Description:
Participants underwent arthroscopic partial menisectomy (APM) surgery and were referred for postoperative rehabilitative physical therapy.
Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
Overall Number of Participants Analyzed 161 169
Mean (95% Confidence Interval)
Unit of Measure: Score
24.2
(20.3 to 28.0)
23.1
(19.2 to 27.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arthroscopic Partial Meniscectomy, Physical Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.68
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
-4.4 to 6.6
Estimation Comments [Not Specified]
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arthroscopic Partial Meniscectomy Physical Therapy
Hide Arm/Group Description Participants underwent arthroscopic partial menisectomy (APM) surgery and were offered postoperative rehabilitative physical therapy. Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
All-Cause Mortality
Arthroscopic Partial Meniscectomy Physical Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arthroscopic Partial Meniscectomy Physical Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/174 (1.72%)      2/177 (1.13%)    
Cardiac disorders     
Cardiovascular   2/174 (1.15%)  2 2/177 (1.13%)  2
Vascular disorders     
Hypoxemia   1/174 (0.57%)  1 0/177 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arthroscopic Partial Meniscectomy Physical Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/174 (8.62%)      13/177 (7.34%)    
Cardiac disorders     
Cardiovascular   6/174 (3.45%)  6 3/177 (1.69%)  3
Musculoskeletal and connective tissue disorders     
Muskuloskeletal   7/174 (4.02%)  7 6/177 (3.39%)  6
Pain in the back, hip, or foot   2/174 (1.15%)  2 4/177 (2.26%)  4
Indicates events were collected by systematic assessment
Surgical randomized controlled trials present methodological challenges, including crossover from one group to the other.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Jeffrey N. Katz, MD, MSc
Organization: The Brigham and Women's Hospital
Phone: 617-732-5338
Responsible Party: Jeffrey Neil Katz, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00597012     History of Changes
Other Study ID Numbers: R01AR055557 ( U.S. NIH Grant/Contract )
First Submitted: January 8, 2008
First Posted: January 17, 2008
Results First Submitted: August 2, 2013
Results First Posted: January 27, 2014
Last Update Posted: March 10, 2017