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: January 30, 2017

Last verified: January 2017

History of Changes

Results First Received: August 2, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: No masking; 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

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

Hispanic

Other

Index Knee
[Units: Participants]

Right

138

Left

101

192

Mean Body-Mass Index ^[1]
[Units: Kg/m^2]
Mean (Standard Deviation)

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]

^[1]

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

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
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
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	ANCOVA
P Value ^[4]	0.26
Mean Difference (Final Values) ^[5]	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]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	No text entered.
[4]	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.
[5]	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

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
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
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	ANCOVA
P Value ^[4]	0.16
Mean Difference (Final Values) ^[5]	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]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	No text entered.
[4]	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.
[5]	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

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
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
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	ANCOVA
P Value ^[4]	0.68
Mean Difference (Net) ^[5]	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]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	No text entered.
[4]	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.
[5]	Other relevant estimation information:
	No text entered.

Serious Adverse Events

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Other Adverse Events

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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:

Katz JN, Chaisson CE, Cole B, Guermazi A, Hunter DJ, Jones M, Levy BA, Mandl LA, Martin S, Marx RG, Safran-Norton C, Roemer FW, Skoniecki D, Solomon DH, Spindler KP, Wright J, Wright RW, Losina E. The MeTeOR trial (Meniscal Tear in Osteoarthritis Research): rationale and design features. Contemp Clin Trials. 2012 Nov;33(6):1189-96. doi: 10.1016/j.cct.2012.08.010. Epub 2012 Sep 5.

Katz JN, Brophy RH, Chaisson CE, de Chaves L, Cole BJ, Dahm DL, Donnell-Fink LA, Guermazi A, Haas AK, Jones MH, Levy BA, Mandl LA, Martin SD, Marx RG, Miniaci A, Matava MJ, Palmisano J, Reinke EK, Richardson BE, Rome BN, Safran-Norton CE, Skoniecki DJ, Solomon DH, Smith MV, Spindler KP, Stuart MJ, Wright J, Wright RW, Losina E. Surgery versus physical therapy for a meniscal tear and osteoarthritis. N Engl J Med. 2013 May 2;368(18):1675-84. doi: 10.1056/NEJMoa1301408. Epub 2013 Mar 18. Erratum in: N Engl J Med. 2013 Aug 15;369(7):683.

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 )
Study First Received:	January 8, 2008
Results First Received:	August 2, 2013
Last Updated:	January 30, 2017

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