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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00597012
Recruitment Status : Active, not recruiting
First Posted : January 17, 2008
Results First Posted : January 27, 2014
Last Update Posted : March 10, 2017
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

  Participant Flow

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was completed on the 330 active participants in the study at 6 months.

Reporting Groups
Arthroscopic Partial Meniscectomy Participants will undergo arthroscopic partial menisectomy (APM) surgery and offered postoperative rehabilitative physical therapy.
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 Total of all reporting groups

Baseline Measures
   Arthroscopic Partial Meniscectomy   Physical Therapy   Total 
Overall Participants Analyzed 
[Units: Participants]
 161   169   330 
Age, Customized 
[Units: Years]
Mean (Standard Deviation)
 59.0  (7.9)   57.8  (6.8)   58.4  (7.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      90  55.9%      97  57.4%      187  56.7% 
Male      71  44.1%      72  42.6%      143  43.3% 
Race/Ethnicity, Customized 
[Units: Participants]
White   138   142   280 
Black or African American   15   17   32 
Hispanic   2   5   7 
Other   6   5   11 
Index Knee 
[Units: Participants]
Right   70   68   138 
Left   91   101   192 
Mean Body-Mass Index [1] 
[Units: Kg/m^2]
Mean (Standard Deviation)
 30.0  (6.1)   30.0  (6.1)   30.0  (6.1) 
[1] The body-mass index is the weight in kilograms divided by the square of the height in meters.
WOMAC physical-function score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 37.1  (17.9)   37.5  (18.3)   37.3  (18.1) 
[1] 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] 
[Units: Units on a scale]
Mean (Standard Deviation)
 46.0  (15.5)   47.2  (16.4)   46.6  (16.0) 
[1] 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] 
[Units: Units on a scale]
Mean (Standard Deviation)
 74.8  (12.9)   74.0  (13.9)   74.4  (13.5) 
[1] 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] 
[Units: Units on a scale]
Mean (Standard Deviation)
 44.3  (23.7)   43.3  (23.3)   43.8  (23.5) 
[1] 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] 
[Units: Participants]
 34   36   70 
 26   35   61 
 37   39   76 
 45   39   84 

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.

  Outcome Measures

1.  Primary:   WOMAC Functional Status - Difference From Baseline   [ Time Frame: Baseline and 6 months ]

2.  Secondary:   KOOS Pain - Difference From Baseline   [ Time Frame: Baseline to 6 months ]

3.  Secondary:   SF-36 Physical Functional Status Scale - Difference From Baseline   [ Time Frame: 6 months ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Surgical randomized controlled trials present methodological challenges, including crossover from one group to the other.

  More Information

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

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Jeffrey Neil Katz, MD, Brigham and Women's Hospital 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