Trial Outcomes & Findings for Prospective Trial of Arthroscopic Meniscectomy for Degenerative Meniscus Tears (NCT NCT01931735)
NCT ID: NCT01931735
Last Updated: 2018-11-21
Results Overview
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.
COMPLETED
NA
27 participants
one year post baseline
2018-11-21
Participant Flow
Participant milestones
| Measure |
Randomized Meniscectomy
This group will have a partial meniscectomy
Meniscectomy: Arthroscopic meniscectomy
|
Randomized Lavage
This group will have arthroscopy and lavage
Arthroscopic Lavage: Arthroscopic Lavage
|
Standard of Care Meniscectomy Pre-Amendment
Pre-Amendment: surgeons determined standard of care option best benefited the patient.
|
Standard of Care Meniscectomy Post Amendment
Post Amendment: patients received a meniscectomy as a standard of care and were observed for 24-months post-operative.
|
|---|---|---|---|---|
|
Randomized Phase
STARTED
|
4
|
3
|
9
|
0
|
|
Randomized Phase
COMPLETED
|
2
|
1
|
4
|
0
|
|
Randomized Phase
NOT COMPLETED
|
2
|
2
|
5
|
0
|
|
Observational Non-Randomized Phase
STARTED
|
2
|
1
|
0
|
11
|
|
Observational Non-Randomized Phase
COMPLETED
|
2
|
1
|
0
|
9
|
|
Observational Non-Randomized Phase
NOT COMPLETED
|
0
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Randomized Meniscectomy
This group will have a partial meniscectomy
Meniscectomy: Arthroscopic meniscectomy
|
Randomized Lavage
This group will have arthroscopy and lavage
Arthroscopic Lavage: Arthroscopic Lavage
|
Standard of Care Meniscectomy Pre-Amendment
Pre-Amendment: surgeons determined standard of care option best benefited the patient.
|
Standard of Care Meniscectomy Post Amendment
Post Amendment: patients received a meniscectomy as a standard of care and were observed for 24-months post-operative.
|
|---|---|---|---|---|
|
Randomized Phase
Lost to Follow-up
|
2
|
2
|
5
|
0
|
|
Observational Non-Randomized Phase
Adverse Event
|
0
|
0
|
0
|
1
|
|
Observational Non-Randomized Phase
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Prospective Trial of Arthroscopic Meniscectomy for Degenerative Meniscus Tears
Baseline characteristics by cohort
| Measure |
Randomized Meniscectomy
n=4 Participants
This group will have a partial meniscectomy
Meniscectomy: Arthroscopic meniscectomy
|
Randomized Lavage
n=3 Participants
This group will have arthroscopy and lavage
Arthroscopic Lavage: Arthroscopic Lavage
|
Standard of Care Meniscectomy Pre-Amendment
n=9 Participants
Pre-Amendment: surgeons determined standard of care option, meniscectomy, best benefited the patient.
|
Standard of Care Meniscectomy Post Amendment
n=11 Participants
Post Amendment: patients received a meniscectomy as a standard of care and were observed for 24-months post-operative.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
57.8 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
54.3 years
STANDARD_DEVIATION 3.5 • n=7 Participants
|
55.6 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
54.5 years
STANDARD_DEVIATION 10.8 • n=4 Participants
|
55.3 years
STANDARD_DEVIATION 8.7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
9 participants
n=5 Participants
|
11 participants
n=4 Participants
|
27 participants
n=21 Participants
|
|
Total WOMET Score
|
44.8 units on a scale
STANDARD_DEVIATION 31.5 • n=5 Participants
|
45.2 units on a scale
STANDARD_DEVIATION 9.1 • n=7 Participants
|
27.5 units on a scale
STANDARD_DEVIATION 12.2 • n=5 Participants
|
33.1 units on a scale
STANDARD_DEVIATION 22.5 • n=4 Participants
|
34.2 units on a scale
STANDARD_DEVIATION 20.2 • n=21 Participants
|
|
KOOS Pain Score
|
29.6 units on a scale
STANDARD_DEVIATION 8.5 • n=5 Participants
|
47.2 units on a scale
STANDARD_DEVIATION 11.78 • n=7 Participants
|
40.1 units on a scale
STANDARD_DEVIATION 12.7 • n=5 Participants
|
42.9 units on a scale
STANDARD_DEVIATION 17.9 • n=4 Participants
|
40.7 units on a scale
STANDARD_DEVIATION 14.8 • n=21 Participants
|
PRIMARY outcome
Timeframe: one year post baselinePopulation: 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.
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.
Outcome measures
| Measure |
Randomized Meniscectomy
n=2 Participants
This group will have a partial meniscectomy
Meniscectomy: Arthroscopic meniscectomy
|
Randomized Lavage
n=1 Participants
This group will have arthroscopy and lavage
Arthroscopic Lavage: Arthroscopic Lavage
|
Standard of Care Meniscectomy Pre-Amendment
n=4 Participants
Pre-Amendment: surgeons determined standard of care option, meniscectomy, best benefited the patient.
|
Standard of Care Meniscectomy Post Amendment
n=10 Participants
Post Amendment: patients received a meniscectomy as a standard of care and were observed for 24-months post-operative.
|
|---|---|---|---|---|
|
WOMET Score
|
57.5 units on a scale
Standard Deviation 42.2
|
99.4 units on a scale
|
37.0 units on a scale
Standard Deviation 18.1
|
63.9 units on a scale
Standard Deviation 21.9
|
PRIMARY outcome
Timeframe: two years post baselinePopulation: 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.
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.
Outcome measures
| Measure |
Randomized Meniscectomy
n=2 Participants
This group will have a partial meniscectomy
Meniscectomy: Arthroscopic meniscectomy
|
Randomized Lavage
n=1 Participants
This group will have arthroscopy and lavage
Arthroscopic Lavage: Arthroscopic Lavage
|
Standard of Care Meniscectomy Pre-Amendment
Pre-Amendment: surgeons determined standard of care option, meniscectomy, best benefited the patient.
|
Standard of Care Meniscectomy Post Amendment
n=9 Participants
Post Amendment: patients received a meniscectomy as a standard of care and were observed for 24-months post-operative.
|
|---|---|---|---|---|
|
WOMET Score
|
49.0 units on a scale
Standard Deviation 50.0
|
99.6 units on a scale
|
—
|
57.4 units on a scale
Standard Deviation 27.9
|
PRIMARY outcome
Timeframe: Two year post baselinePopulation: 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.
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).
Outcome measures
| Measure |
Randomized Meniscectomy
n=1 Participants
This group will have a partial meniscectomy
Meniscectomy: Arthroscopic meniscectomy
|
Randomized Lavage
n=1 Participants
This group will have arthroscopy and lavage
Arthroscopic Lavage: Arthroscopic Lavage
|
Standard of Care Meniscectomy Pre-Amendment
Pre-Amendment: surgeons determined standard of care option, meniscectomy, best benefited the patient.
|
Standard of Care Meniscectomy Post Amendment
n=9 Participants
Post Amendment: patients received a meniscectomy as a standard of care and were observed for 24-months post-operative.
|
|---|---|---|---|---|
|
Gait Knee Adduction Moment
|
-3.32 percentage of body weight times height
|
-5.40 percentage of body weight times height
|
—
|
-2.15 percentage of body weight times height
Standard Deviation 0.51
|
PRIMARY outcome
Timeframe: Two years post baselinePopulation: 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.
Degree of external tibial rotation averaged over the stance phase of gait.
Outcome measures
| Measure |
Randomized Meniscectomy
n=1 Participants
This group will have a partial meniscectomy
Meniscectomy: Arthroscopic meniscectomy
|
Randomized Lavage
n=1 Participants
This group will have arthroscopy and lavage
Arthroscopic Lavage: Arthroscopic Lavage
|
Standard of Care Meniscectomy Pre-Amendment
Pre-Amendment: surgeons determined standard of care option, meniscectomy, best benefited the patient.
|
Standard of Care Meniscectomy Post Amendment
n=8 Participants
Post Amendment: patients received a meniscectomy as a standard of care and were observed for 24-months post-operative.
|
|---|---|---|---|---|
|
Average Rotation During Stance
|
12.5 degrees
|
8.2 degrees
|
—
|
8.9 degrees
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: two years post baselinePopulation: 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.
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.
Outcome measures
| Measure |
Randomized Meniscectomy
n=2 Participants
This group will have a partial meniscectomy
Meniscectomy: Arthroscopic meniscectomy
|
Randomized Lavage
n=1 Participants
This group will have arthroscopy and lavage
Arthroscopic Lavage: Arthroscopic Lavage
|
Standard of Care Meniscectomy Pre-Amendment
Pre-Amendment: surgeons determined standard of care option, meniscectomy, best benefited the patient.
|
Standard of Care Meniscectomy Post Amendment
n=9 Participants
Post Amendment: patients received a meniscectomy as a standard of care and were observed for 24-months post-operative.
|
|---|---|---|---|---|
|
KOOS Pain Score
|
48.6 units on a scale
Standard Deviation 41.2
|
100 units on a scale
|
—
|
68.5 units on a scale
Standard Deviation 26.3
|
SECONDARY outcome
Timeframe: one year post baselinePopulation: 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
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.
Outcome measures
| Measure |
Randomized Meniscectomy
n=2 Participants
This group will have a partial meniscectomy
Meniscectomy: Arthroscopic meniscectomy
|
Randomized Lavage
n=1 Participants
This group will have arthroscopy and lavage
Arthroscopic Lavage: Arthroscopic Lavage
|
Standard of Care Meniscectomy Pre-Amendment
n=4 Participants
Pre-Amendment: surgeons determined standard of care option, meniscectomy, best benefited the patient.
|
Standard of Care Meniscectomy Post Amendment
n=10 Participants
Post Amendment: patients received a meniscectomy as a standard of care and were observed for 24-months post-operative.
|
|---|---|---|---|---|
|
KOOS Pain Score
|
38.9 units on a scale
Standard Deviation 39.3
|
100 units on a scale
|
36.8 units on a scale
Standard Deviation 15.4
|
66.7 units on a scale
Standard Deviation 16.9
|
SECONDARY outcome
Timeframe: BaselinePopulation: No participants were assessed for this measure (data were not collected).
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.
Outcome measures
Outcome data not reported
Adverse Events
Randomized Meniscectomy
Randomized Lavage
Standard of Care Meniscectomy Pre-Amendment
Standard of Care Meniscectomy Post Amendment
Serious adverse events
| Measure |
Randomized Meniscectomy
n=4 participants at risk
This group will have a partial meniscectomy
Meniscectomy: Arthroscopic meniscectomy
|
Randomized Lavage
n=3 participants at risk
This group will have arthroscopy and lavage
Arthroscopic Lavage: Arthroscopic Lavage
|
Standard of Care Meniscectomy Pre-Amendment
n=9 participants at risk
Pre-Amendment: surgeons determined standard of care option, meniscectomy, best benefited the patient.
|
Standard of Care Meniscectomy Post Amendment
n=11 participants at risk
Post Amendment: patients received a meniscectomy as a standard of care and were observed for 24-months post-operative.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Car accident
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/9 • 2 years
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Endocrine disorders
Diabetic Ulcer
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/9 • 2 years
|
9.1%
1/11 • Number of events 1 • 2 years
|
Other adverse events
| Measure |
Randomized Meniscectomy
n=4 participants at risk
This group will have a partial meniscectomy
Meniscectomy: Arthroscopic meniscectomy
|
Randomized Lavage
n=3 participants at risk
This group will have arthroscopy and lavage
Arthroscopic Lavage: Arthroscopic Lavage
|
Standard of Care Meniscectomy Pre-Amendment
n=9 participants at risk
Pre-Amendment: surgeons determined standard of care option, meniscectomy, best benefited the patient.
|
Standard of Care Meniscectomy Post Amendment
n=11 participants at risk
Post Amendment: patients received a meniscectomy as a standard of care and were observed for 24-months post-operative.
|
|---|---|---|---|---|
|
Immune system disorders
Rheumatoid Arthritis
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/9 • 2 years
|
9.1%
1/11 • Number of events 1 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place