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Prospective Trial of Arthroscopic Meniscectomy for Degenerative Meniscus Tears

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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

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Meniscus Tear
Interventions Procedure: Randomized Meniscectomy
Procedure: Randomized Lavage
Procedure: Standard of Care Meniscectomy Pre-Amend
Procedure: Standard of Care Meniscectomy Post-Amend
Enrollment 27
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Randomized Meniscectomy Randomized Lavage Standard of Care Meniscectomy Pre-Amendment Standard of Care Meniscectomy Post Amendment
Hide Arm/Group Description

This group will have a partial meniscectomy

Meniscectomy: Arthroscopic meniscectomy

This group will have arthroscopy and lavage

Arthroscopic Lavage: Arthroscopic Lavage

Pre-Amendment: surgeons determined standard of care option best benefited the patient. Post Amendment: patients received a meniscectomy as a standard of care and were observed for 24-months post-operative.
Period Title: Randomized Phase
Started 4 3 9 0
Completed 2 1 4 0
Not Completed 2 2 5 0
Reason Not Completed
Lost to Follow-up             2             2             5             0
Period Title: Observational Non-Randomized Phase
Started 2 [1] 1 [1] 0 11 [2]
Completed 2 1 0 9
Not Completed 0 0 0 2
Reason Not Completed
Adverse Event             0             0             0             1
Withdrawal by Subject             0             0             0             1
[1]
Participants continued from the randomized phase
[2]
Participants recruited post-amendment
Arm/Group Title Randomized Meniscectomy Randomized Lavage Standard of Care Meniscectomy Pre-Amendment Standard of Care Meniscectomy Post Amendment Total
Hide Arm/Group Description

This group will have a partial meniscectomy

Meniscectomy: Arthroscopic meniscectomy

This group will have arthroscopy and lavage

Arthroscopic Lavage: Arthroscopic Lavage

Pre-Amendment: surgeons determined standard of care option, meniscectomy, best benefited the patient. Post Amendment: patients received a meniscectomy as a standard of care and were observed for 24-months post-operative. Total of all reporting groups
Overall Number of Baseline Participants 4 3 9 11 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 3 participants 9 participants 11 participants 27 participants
57.8  (9.5) 54.3  (3.5) 55.6  (7.7) 54.5  (10.8) 55.3  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 9 participants 11 participants 27 participants
Female
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
1
   3.7%
Male
4
 100.0%
2
  66.7%
9
 100.0%
11
 100.0%
26
  96.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 9 participants 11 participants 27 participants
Caucasian
1
  25.0%
2
  66.7%
6
  66.7%
5
  45.5%
14
  51.9%
Hispanic
1
  25.0%
0
   0.0%
1
  11.1%
2
  18.2%
4
  14.8%
Unknown
2
  50.0%
0
   0.0%
2
  22.2%
0
   0.0%
4
  14.8%
African American
0
   0.0%
1
  33.3%
0
   0.0%
3
  27.3%
4
  14.8%
Other
0
   0.0%
0
   0.0%
0
   0.0%
1
   9.1%
1
   3.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 3 participants 9 participants 11 participants 27 participants
4 3 9 11 27
Total WOMET Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 4 participants 3 participants 9 participants 11 participants 27 participants
44.8  (31.5) 45.2  (9.1) 27.5  (12.2) 33.1  (22.5) 34.2  (20.2)
[1]
Measure Description: 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.
KOOS Pain Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 4 participants 3 participants 9 participants 11 participants 27 participants
29.6  (8.5) 47.2  (11.78) 40.1  (12.7) 42.9  (17.9) 40.7  (14.8)
[1]
Measure Description: 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.
1.Primary Outcome
Title WOMET Score
Hide Description 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.
Time Frame one year post baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Randomize Meniscectomy: 2 lost to follow-up. Randomized Lavage: 2 lost to follow-up. Standard of Care Meniscectomy Pre-Amendment: 5 lost to follow-up. Standard of Care Meniscectomy Post Amendment: 1 withdrew participation.
Arm/Group Title Randomized Meniscectomy Randomized Lavage Standard of Care Meniscectomy Pre-Amendment Standard of Care Meniscectomy Post Amendment
Hide Arm/Group Description:

This group will have a partial meniscectomy

Meniscectomy: Arthroscopic meniscectomy

This group will have arthroscopy and lavage

Arthroscopic Lavage: Arthroscopic Lavage

Pre-Amendment: surgeons determined standard of care option, meniscectomy, best benefited the patient.
Post Amendment: patients received a meniscectomy as a standard of care and were observed for 24-months post-operative.
Overall Number of Participants Analyzed 2 1 4 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
57.5  (42.2) 99.4 37.0  (18.1) 63.9  (21.9)
2.Primary Outcome
Title WOMET Score
Hide Description 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.
Time Frame two years post baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Randomize meniscectomy: 2 lost to follow-up. Randomized Lavage: 2 lost to follow-up. Standard of care meniscectomy pre-amendment: not in protocol to follow subjects 2 years post baseline. Standard of care meniscectomy post-amendment: 1 withdraw, 1 adverse event.
Arm/Group Title Randomized Meniscectomy Randomized Lavage Standard of Care Meniscectomy Pre-Amendment Standard of Care Meniscectomy Post Amendment
Hide Arm/Group Description:

This group will have a partial meniscectomy

Meniscectomy: Arthroscopic meniscectomy

This group will have arthroscopy and lavage

Arthroscopic Lavage: Arthroscopic Lavage

Pre-Amendment: surgeons determined standard of care option, meniscectomy, best benefited the patient.
Post Amendment: patients received a meniscectomy as a standard of care and were observed for 24-months post-operative.
Overall Number of Participants Analyzed 2 1 0 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
49.0  (50.0) 99.6 57.4  (27.9)
3.Primary Outcome
Title Gait Knee Adduction Moment
Hide Description 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).
Time Frame Two year post baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Standard of Care Meniscectomy Pre-Amendment group were not assessed for this outcome. Randomized Meniscectomy: 1 was not assessed due to relocation, 2 were lost to follow-up. Randomized lavage: 2 participants were lost to follow-up. Standard of Care Meniscectomy Post Amendment: 1 had an adverse event, 1 participant withdrew from the study.
Arm/Group Title Randomized Meniscectomy Randomized Lavage Standard of Care Meniscectomy Pre-Amendment Standard of Care Meniscectomy Post Amendment
Hide Arm/Group Description:

This group will have a partial meniscectomy

Meniscectomy: Arthroscopic meniscectomy

This group will have arthroscopy and lavage

Arthroscopic Lavage: Arthroscopic Lavage

Pre-Amendment: surgeons determined standard of care option, meniscectomy, best benefited the patient.
Post Amendment: patients received a meniscectomy as a standard of care and were observed for 24-months post-operative.
Overall Number of Participants Analyzed 1 1 0 9
Mean (Standard Deviation)
Unit of Measure: percentage of body weight times height
-3.32 -5.40 -2.15  (0.51)
4.Primary Outcome
Title Average Rotation During Stance
Hide Description Degree of external tibial rotation averaged over the stance phase of gait.
Time Frame Two years post baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Standard of Care Meniscectomy Pre-Amendment group were not assessed for this outcome. Randomized Meniscectomy: 1 was not assessed due to relocation, 2 were lost to follow-up. Randomized lavage: 2 participants were lost to follow-up. Standard of Care Meniscectomy Post Amendment: 1 had an adverse event, 1 participant withdrew from the study.
Arm/Group Title Randomized Meniscectomy Randomized Lavage Standard of Care Meniscectomy Pre-Amendment Standard of Care Meniscectomy Post Amendment
Hide Arm/Group Description:

This group will have a partial meniscectomy

Meniscectomy: Arthroscopic meniscectomy

This group will have arthroscopy and lavage

Arthroscopic Lavage: Arthroscopic Lavage

Pre-Amendment: surgeons determined standard of care option, meniscectomy, best benefited the patient.
Post Amendment: patients received a meniscectomy as a standard of care and were observed for 24-months post-operative.
Overall Number of Participants Analyzed 1 1 0 8
Mean (Standard Deviation)
Unit of Measure: degrees
12.5 8.2 8.9  (4.7)
5.Secondary Outcome
Title KOOS Pain Score
Hide Description 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.
Time Frame two years post baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Randomize meniscectomy: 2 lost to follow-up. Randomized Lavage: 2 lost to follow-up. Standard of care meniscectomy pre-amendment: not in protocol to follow subjects 2 years post baseline. Standard of care meniscectomy post-amendment: 1 withdraw, 1 adverse event.
Arm/Group Title Randomized Meniscectomy Randomized Lavage Standard of Care Meniscectomy Pre-Amendment Standard of Care Meniscectomy Post Amendment
Hide Arm/Group Description:

This group will have a partial meniscectomy

Meniscectomy: Arthroscopic meniscectomy

This group will have arthroscopy and lavage

Arthroscopic Lavage: Arthroscopic Lavage

Pre-Amendment: surgeons determined standard of care option, meniscectomy, best benefited the patient.
Post Amendment: patients received a meniscectomy as a standard of care and were observed for 24-months post-operative.
Overall Number of Participants Analyzed 2 1 0 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
48.6  (41.2) 100 68.5  (26.3)
6.Secondary Outcome
Title KOOS Pain Score
Hide Description 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.
Time Frame one year post baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Randomize meniscectomy: 2 lost to follow-up. Randomized Lavage: 2 lost to follow-up. Standard of care meniscectomy pre-amendment: 5 lost to follow-up. Standard of care meniscectomy post-amendment: 1 withdraw
Arm/Group Title Randomized Meniscectomy Randomized Lavage Standard of Care Meniscectomy Pre-Amendment Standard of Care Meniscectomy Post Amendment
Hide Arm/Group Description:

This group will have a partial meniscectomy

Meniscectomy: Arthroscopic meniscectomy

This group will have arthroscopy and lavage

Arthroscopic Lavage: Arthroscopic Lavage

Pre-Amendment: surgeons determined standard of care option, meniscectomy, best benefited the patient.
Post Amendment: patients received a meniscectomy as a standard of care and were observed for 24-months post-operative.
Overall Number of Participants Analyzed 2 1 4 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
38.9  (39.3) 100 36.8  (15.4) 66.7  (16.9)
7.Secondary Outcome
Title TNFa
Hide Description 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.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
No participants were assessed for this measure (data were not collected).
Arm/Group Title Randomized Meniscectomy Randomized Lavage Standard of Care Meniscectomy Pre-Amendment Standard of Care Meniscectomy Post Amendment
Hide Arm/Group Description:

This group will have a partial meniscectomy

Meniscectomy: Arthroscopic meniscectomy

This group will have arthroscopy and lavage

Arthroscopic Lavage: Arthroscopic Lavage

Pre-Amendment: surgeons determined standard of care option, meniscectomy, best benefited the patient.
Post Amendment: patients received a meniscectomy as a standard of care and were observed for 24-months post-operative.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Randomized Meniscectomy Randomized Lavage Standard of Care Meniscectomy Pre-Amendment Standard of Care Meniscectomy Post Amendment
Hide Arm/Group Description

This group will have a partial meniscectomy

Meniscectomy: Arthroscopic meniscectomy

This group will have arthroscopy and lavage

Arthroscopic Lavage: Arthroscopic Lavage

Pre-Amendment: surgeons determined standard of care option, meniscectomy, best benefited the patient. Post Amendment: patients received a meniscectomy as a standard of care and were observed for 24-months post-operative.
All-Cause Mortality
Randomized Meniscectomy Randomized Lavage Standard of Care Meniscectomy Pre-Amendment Standard of Care Meniscectomy Post Amendment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)      0/3 (0.00%)      0/9 (0.00%)      0/11 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Randomized Meniscectomy Randomized Lavage Standard of Care Meniscectomy Pre-Amendment Standard of Care Meniscectomy Post Amendment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/4 (0.00%)      0/3 (0.00%)      0/9 (0.00%)      2/11 (18.18%)    
Endocrine disorders         
Diabetic Ulcer * [1]  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 1/11 (9.09%)  1
Injury, poisoning and procedural complications         
Car accident * [2]  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 1/11 (9.09%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Diabetic ulcer resulted in toe amputation. This adverse event is unrelated to the study.
[2]
Wrist reconstructed due to a car accident injury. Injury is unrelated to the study.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Randomized Meniscectomy Randomized Lavage Standard of Care Meniscectomy Pre-Amendment Standard of Care Meniscectomy Post Amendment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/4 (0.00%)      0/3 (0.00%)      0/9 (0.00%)      1/11 (9.09%)    
Immune system disorders         
Rheumatoid Arthritis * [1]  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 1/11 (9.09%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Unrelated to the study.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Jessica Asay
Organization: VA Palo Alto Research
Phone: 650-493-5000 ext 65971
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 Submitted: August 23, 2013
First Posted: August 29, 2013
Results First Submitted: March 30, 2018
Results First Posted: October 26, 2018
Last Update Posted: November 21, 2018