Prospective Trial of Arthroscopic Meniscectomy for Degenerative Meniscus Tears

NCT01931735 | Completed Results DMC

• 2 other identifiers: E0924-R1I01RX000924-01A2
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Meniscus Tear

Keywords

menisci; tibial

Outcome Measures

Primary Outcomes (4)

• WOMET Score

  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.

  one year post baseline

• WOMET Score

  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.

  two years post baseline

• Gait Knee Adduction Moment

  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).

  Two year post baseline

• Average Rotation During Stance

  Degree of external tibial rotation averaged over the stance phase of gait.

  Two years post baseline

Secondary Outcomes (3)

• KOOS Pain Score

  two years post baseline

• KOOS Pain Score

  one year post baseline

• TNFa

  Baseline

Study Arms (4)

Randomized Meniscectomy

EXPERIMENTAL

This group will have a partial meniscectomy

Procedure: Randomized Meniscectomy

Randomized Lavage

ACTIVE COMPARATOR

This group will have arthroscopy and lavage

Procedure: Randomized Lavage

Standard of Care Meniscectomy Pre-Amend

OTHER

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

Standard of Care Meniscectomy Post-Amend

OTHER

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

Interventions

Randomized Meniscectomy PROCEDURE

Arthroscopic meniscectomy

Randomized Meniscectomy

Randomized Lavage PROCEDURE

Arthroscopic Lavage

Randomized Lavage

Standard of Care Meniscectomy Pre-Amend PROCEDURE

Arthroscopic meniscectomy

Standard of Care Meniscectomy Pre-Amend

Standard of Care Meniscectomy Post-Amend PROCEDURE

Arthroscopic meniscectomy

Standard of Care Meniscectomy Post-Amend

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1290, United States

Location

Related Publications (2)

• Edd SN, Giori NJ, Andriacchi TP. The role of inflammation in the initiation of osteoarthritis after meniscal damage. J Biomech. 2015 Jun 1;48(8):1420-6. doi: 10.1016/j.jbiomech.2015.02.035. Epub 2015 Feb 26.

  PMID: 25798759 BACKGROUND

• Edd SN, Netravali NA, Favre J, Giori NJ, Andriacchi TP. Alterations in knee kinematics after partial medial meniscectomy are activity dependent. Am J Sports Med. 2015 Jun;43(6):1399-407. doi: 10.1177/0363546515577360. Epub 2015 Mar 31.

  PMID: 25828080 BACKGROUND

Results Point of Contact

• Title: Jessica Asay
• Organization: VA Palo Alto Research

asay@stanford.edu

650-493-5000

Study Officials

• Nicholas J. Giori, MD PhD

  VA Palo Alto Health Care System, Palo Alto, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2013
• First Posted: August 29, 2013
• Study Start: October 1, 2013
• Primary Completion: January 31, 2018
• Study Completion: January 31, 2018
• Last Updated: November 21, 2018
• Results First Posted: October 26, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)