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Arthroscopic Partial Meniscectomy Time Window

Effect of Early vs Delayed Arthroscopic Partial Meniscectomy on the Knee Function of Patients With Degenerative Meniscus Lesions

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05655442
Enrollment
0
Registered
2022-12-19
Start date
2020-01-12
Completion date
2023-08-28
Last updated
2023-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meniscus Lesion

Brief summary

The purpose was to assess knee function outcomes between early arthroscopic partial meniscectomy(APM) and delayed APM for patients with degenerative meniscus lesions(DMLs)

Detailed description

Whether early APM surgery or delayed APM surgery will more benefit for patients with DMLs. The study was to determine the early APM vs delayed APM effect on knee function outcomes for patients with DMLs for 1 year follow-up.

Interventions

PROCEDUREearly APM

early APM within 3 and 6 month knee pain symptoms

PROCEDUREdelayed APM

delayed APM within 6 and 12 month knee pain symptoms

Sponsors

Shenzhen People's Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* • Clinical diagnosis of degenerative meniscus lesions based on knee MRI

Exclusion criteria

* • Must be able to have no acute knee injury such as car crash or acute sports injury; * Must be able to have no knee surgeries history; * Must be able to have no rheumatoid arthritis or serious knee osteoarthritis with deformity; * Must be able to have no contraindications to MRI; * Must be able to have no severe cardiopulmonary disease; * Must be able to have no musculoskeletal or neuromuscular impairments ; * Must be able to have good visual, hearing, or cognitive;

Design outcomes

Primary

MeasureTime frameDescription
the Knee Injury and Osteoarthritis Outcome Score (KOOS) changechange from baseline up to 12 monthsThe Knee injury and Osteoarthritis Outcome Score (KOOS) holds five subscales including: Pain (9 items); other Symptoms (7 items); Activities of Daily Living (ADL, 17 items); Sport and Recreation function (Sport/Rec, 5 items); and knee-related Quality of Life (QoL, 4 items). Each subscale is scored separately from zero (extreme knee problems) to 100 (no knee problems)
International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC Score) changechange from baseline up to 12 monthsThe International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC) score questionnaire contains 18 items (7 items for symptoms, 1 item for sport activity, 9 items for daily activities, and 1 item for current knee function.) The total score is transformed to a value on a scale of 0 to 100, with 100 representing the highest knee function and 0 is the worst.
Kellgren-Lawrence (K/L) grade changechange from baseline up to 12 monthsKellgren-Lawrence (K/L) grade via X ray
the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) changechange from baseline up to 12 monthsTe WOMAC is a self assessed health status scale for patients consisting of 24 items in three subscales of pain (5 items), stiffness (2 items), and physical function (17 items). All items are scored from 0 (asymptomatic) to 4 (very severe), and the total score ranges from 0 to 96, with higher scores indicating more severe symptoms

Secondary

MeasureTime frameDescription
KOOS pain score changechange from baseline up to 12 monthsThe minimum is 0 points, the maximum is 4 points, from extreme knee problems to no knee problems. After the score of each part is calculated separately, it is converted into a percentage score by the conversion formula.
KOOS knee related quality of life score changechange from baseline up to 12 monthsThe minimum is 0 points, the maximum is 4 points, from extreme knee problems to no knee problems. After the score of each part is calculated separately, it is converted into a percentage score by the conversion formula.
KOOS symptoms score changechange from baseline up to 12 monthsThe minimum is 0 points, the maximum is 4 points, from extreme knee problems to no knee problems. After the score of each part is calculated separately, it is converted into a percentage score by the conversion formula.
KOOS activities of daily living score changechange from baseline up to 12 monthsThe minimum is 0 points, the maximum is 4 points, from extreme knee problems to no knee problems. After the score of each part is calculated separately, it is converted into a percentage score by the conversion formula.
KOOS function in sport and recreation score changechange from baseline up to 12 monthsThe minimum is 0 points, the maximum is 4 points, from extreme knee problems to no knee problems. After the score of each part is calculated separately, it is converted into a percentage score by the conversion formula.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026