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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jeffrey Neil Katz, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00597012
First received: January 8, 2008
Last updated: December 19, 2013
Last verified: December 2013
Results First Received: August 2, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Osteoarthritis
Interventions: Procedure: Arthroscopic partial menisectomy
Other: Standard physical therapy
Other: Postoperative rehabilitative physical therapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Arthroscopic Partial Meniscectomy (APM)     Physical Therapy (PT)  
STARTED     174     177  
COMPLETED     161     169  
NOT COMPLETED     13     8  
Death                 1                 1  
Underwent Total Knee Replacement (TKR)                 3                 1  
Withdrawal by Subject                 7                 4  
Ineligible                 2                 0  
Lost to Follow-up                 0                 2  



  Baseline Characteristics
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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
  Description
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  
Number of Participants  
[units: participants]
  161     169     330  
Age, Customized  
[units: years]
Mean ± Standard Deviation
  59.0  ± 7.9     57.8  ± 6.8     58.4  ± 7.3  
Gender  
[units: participants]
     
Female     90     97     187  
Male     71     72     143  
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  
WOMAC physical-function score [2]
[units: Units on a scale]
Mean ± Standard Deviation
  37.1  ± 17.9     37.5  ± 18.3     37.3  ± 18.1  
KOOS pain score [3]
[units: Units on a scale]
Mean ± Standard Deviation
  46.0  ± 15.5     47.2  ± 16.4     46.6  ± 16.0  
Mental Health Index 5 score [4]
[units: Units on a scale]
Mean ± Standard Deviation
  74.8  ± 12.9     74.0  ± 13.9     74.4  ± 13.5  
SF-36 Physical Activity score [5]
[units: Units on a scale]
Mean ± Standard Deviation
  44.3  ± 23.7     43.3  ± 23.3     43.8  ± 23.5  
Kellgren-Lawrence grade [6]
[units: participants]
     
0     34     36     70  
1     26     35     61  
2     37     39     76  
3     45     39     84  
[1] The body-mass index is the weight in kilograms divided by the square of the height in meters.
[2] 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.
[3] 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.
[4] Scores on the Mental Health Index 5 range from 0 to 100, with higher scores indicating better mental health.
[5] 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]

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

Measure Type Primary
Measure Title WOMAC Functional Status - Difference From Baseline
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. 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  
Safety Issue No  

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.
No text entered.

Reporting Groups
  Description
Arthroscopic Partial Meniscectomy Participants underwent arthroscopic partial menisectomy (APM) surgery and were referred for postoperative rehabilitative physical therapy.
Physical Therapy Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.

Measured Values
    Arthroscopic Partial Meniscectomy     Physical Therapy  
Number of Participants Analyzed  
[units: participants]
  161     169  
WOMAC Functional Status - Difference From Baseline  
[units: Score]
Mean ( 95% Confidence Interval )
  20.9  
  ( 17.9 to 23.9 )  
  18.5  
  ( 15.6 to 21.5 )  


Statistical Analysis 1 for WOMAC Functional Status - Difference From Baseline
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.26
Mean Difference (Final Values) [4] 2.4
95% Confidence Interval ( -1.8 to 6.5 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
 

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.

[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



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

Measure Type Secondary
Measure Title KOOS Pain - Difference From Baseline
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. 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  
Safety Issue No  

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.
No text entered.

Reporting Groups
  Description
Arthroscopic Partial Meniscectomy Participants underwent arthroscopic partial menisectomy (APM) surgery and were referred for postoperative rehabilitative physical therapy.
Physical Therapy Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.

Measured Values
    Arthroscopic Partial Meniscectomy     Physical Therapy  
Number of Participants Analyzed  
[units: participants]
  161     169  
KOOS Pain - Difference From Baseline  
[units: Score]
Mean ( 95% Confidence Interval )
  24.2  
  ( 21.3 to 27.1 )  
  21.3  
  ( 18.4 to 24.2 )  


Statistical Analysis 1 for KOOS Pain - Difference From Baseline
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.16
Mean Difference (Final Values) [4] 2.9
95% Confidence Interval ( -1.2 to 7.0 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



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

Measure Type Secondary
Measure Title SF-36 Physical Functional Status Scale - Difference From Baseline
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.
Time Frame 6 months  
Safety Issue No  

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.
No text entered.

Reporting Groups
  Description
Arthroscopic Partial Meniscectomy Participants underwent arthroscopic partial menisectomy (APM) surgery and were referred for postoperative rehabilitative physical therapy.
Physical Therapy Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.

Measured Values
    Arthroscopic Partial Meniscectomy     Physical Therapy  
Number of Participants Analyzed  
[units: participants]
  161     169  
SF-36 Physical Functional Status Scale - Difference From Baseline  
[units: Score]
Mean ( 95% Confidence Interval )
  24.2  
  ( 20.3 to 28.0 )  
  23.1  
  ( 19.2 to 27.0 )  


Statistical Analysis 1 for SF-36 Physical Functional Status Scale - Difference From Baseline
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.68
Mean Difference (Net) [4] 1.1
95% Confidence Interval ( -4.4 to 6.6 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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
e-mail: jnkatz@partners.org


Publications:

Responsible Party: Jeffrey Neil Katz, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00597012     History of Changes
Other Study ID Numbers: R01 AR055557
Study First Received: January 8, 2008
Results First Received: August 2, 2013
Last Updated: December 19, 2013
Health Authority: United States: Federal Government