Meniscus Tear Clinical Trial
Official title:
Prospective Trial of Arthroscopic Meniscectomy for Degenerative Meniscus Tears
Verified date | October 2018 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 27 |
Est. completion date | January 31, 2018 |
Est. primary completion date | January 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
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. Review. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Average Rotation During Stance | Degree of external tibial rotation averaged over the stance phase of gait. | Two years post baseline | |
Secondary | KOOS Pain Score | 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. | two years post baseline | |
Secondary | KOOS Pain Score | 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. | one year post baseline | |
Secondary | TNFa | 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. | Baseline |
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