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Prospective Trial of Arthroscopic Meniscectomy for Degenerative Meniscus Tears

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.
 
ClinicalTrials.gov Identifier: NCT01931735
Recruitment Status : Completed
First Posted : August 29, 2013
Results First Posted : October 26, 2018
Last Update Posted : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
Arthroscopic meniscectomy is among the most commonly performed orthopedic surgical procedures in the VA system. There remains substantial uncertainty, however, regarding the short term benefits and the long term consequences of arthroscopic meniscectomy in patients with degenerative meniscus tears. Of major concern is the fact that degenerative meniscus tears are associated with osteoarthritis, and it is known that within two years of surgery, arthroscopic debridement for osteoarthritis is no better than placebo in relieving pain and restoring function. Longer term, meniscectomy has been shown to be associated with elevated risk of osteoarthritis development, raising the concern that meniscectomy can actually be harmful. The purpose of this study is to determine whether meniscectomy in the setting of a degenerative meniscus tear is of any clinical value. Determining this would either justify the expenses associated with arthroscopic meniscectomy on a large number of patients, or would identify an area of significant potential cost savings.

Condition or disease Intervention/treatment Phase
Meniscus Tear Procedure: Randomized Meniscectomy Procedure: Randomized Lavage Procedure: Standard of Care Meniscectomy Pre-Amend Procedure: Standard of Care Meniscectomy Post-Amend Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Trial of Arthroscopic Meniscectomy for Degenerative Meniscus Tears
Actual Study Start Date : October 1, 2013
Actual Primary Completion Date : January 31, 2018
Actual Study Completion Date : January 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
Experimental: Randomized Meniscectomy
This group will have a partial meniscectomy
Procedure: Randomized Meniscectomy
Arthroscopic meniscectomy

Active Comparator: Randomized Lavage
This group will have arthroscopy and lavage
Procedure: Randomized Lavage
Arthroscopic Lavage

Standard of Care Meniscectomy Pre-Amend
Pre-Amendment: surgeons determined standard of care option, meniscectomy, best benefited the patient. Therefore, the patient was not randomized.
Procedure: Standard of Care Meniscectomy Pre-Amend
Arthroscopic meniscectomy

Standard of Care Meniscectomy Post-Amend
Post Amendment: patients received a meniscectomy as a standard of care and were observed for 24-months post-operative.
Procedure: Standard of Care Meniscectomy Post-Amend
Arthroscopic meniscectomy




Primary Outcome Measures :
  1. WOMET Score [ Time Frame: one year post baseline ]
    Western Ontario Meniscal Evaluation Tool (WOMET) is a standardized and validated survey used to evaluate the pain and function of patients with a degenerative meniscal tear. The survey consists of 16 questions regarding physical symptoms, sports/recreation/work/lifestyle, and emotions. Each question is answered via a visual analog scale (VAS) of 0-100mm for a total score of 1600, where higher numbers are worse. The score is then transformed into a percentage, where 0 is the worst pain and functioning and 100% is no pain and fully functioning.

  2. WOMET Score [ Time Frame: two years post baseline ]
    Western Ontario Meniscal Evaluation Tool (WOMET) is a standardized and validated survey used to evaluate the pain and function of patients with a degenerative meniscal tear. The survey consists of 16 questions regarding physical symptoms, sports/recreation/work/lifestyle, and emotions. Each question is answered via a visual analog scale (VAS) of 0-100mm for a total score of 1600, where higher numbers are worse. The score is then transformed into a percentage, where 0 is the worst pain and functioning and 100% is no pain and fully functioning.

  3. Gait Knee Adduction Moment [ Time Frame: Two year post baseline ]
    Knee adduction moment describes the medial/lateral load distribution of the knee measured while walking in a gait laboratory. Before normalization to account for size, the knee adduction moment is expressed in Nm. However, to account for different sized people, the knee adduction moment is transformed and expressed in percentage of body weight times height (%BW*ht). Higher knee adduction moments have been linked to more severe osteoarthritis (OA).

  4. Average Rotation During Stance [ Time Frame: Two years post baseline ]
    Degree of external tibial rotation averaged over the stance phase of gait.


Secondary Outcome Measures :
  1. KOOS Pain Score [ Time Frame: two years post baseline ]
    Knee injury and Osteoarthritis Outcome Score (KOOS) is a standardized and validated survey used to evaluate the condition of osteoarthritis of the knee. The KOOS Pain scale consists of 9 questions, with each response valued on an ordinal scale of 0-4, and with at total score of 36. Higher numbers indicate more symptoms and physical disabilities. The score is then transformed into a percentage, where 0% is the worst pain and 100% is no pain.

  2. KOOS Pain Score [ Time Frame: one year post baseline ]
    Knee injury and Osteoarthritis Outcome Score (KOOS) is a standardized and validated survey used to evaluate the condition of osteoarthritis of the knee. The KOOS Pain scale consists of 9 questions, with each response valued on an ordinal scale of 0-4, and with at total score of 36. Higher numbers indicate more symptoms and physical disabilities. The score is then transformed into a percentage, where 0% is the worst pain and 100% is no pain.

  3. TNFa [ Time Frame: Baseline ]
    Tumor necrosis factor-alpha (TNFa) is a pro-inflammatory cytokine that has been linked to the presence of radiographic signs of osteoarthritis (OA), cartilage volume loss over time, increased disease severity, and risk of OA progression. Elevated presence of TNFa can indicate more risk for OA. The unit of measure is pg/mL.



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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Veteran
  • Age between 45 and 70 years
  • Degenerative meniscus tear as seen on standard clinical MRI scan
  • Complaint of "mechanical symptoms" which would include popping, catching, or locking of the knee
  • Persistent symptoms for a minimum of three months despite conservative management
  • Patient is enrolled for arthroscopic meniscectomy
  • Subject agrees to the study follow-up schedule and signs informed consent.

Exclusion Criteria:

  • Radiographic osteoarthritis of the knee in any compartment greater than KL grade 2
  • Prior knee arthroscopy within two years of study enrollment
  • Unable to have an MRI scan
  • Does not agree to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01931735


Locations
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United States, California
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States, 94304-1290
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Nicholas J. Giori, MD PhD VA Palo Alto Health Care System, Palo Alto, CA
  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:

Publications:
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01931735     History of Changes
Other Study ID Numbers: E0924-R
1I01RX000924-01A2 ( U.S. NIH Grant/Contract )
First Posted: August 29, 2013    Key Record Dates
Results First Posted: October 26, 2018
Last Update Posted: November 21, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
menisci
tibial