Arthroscopic Partial Meniscectomy Time Window

Not Applicable

Withdrawn

• Conditions: Meniscus Lesion
• Interventions: Procedure: delayed APM; Procedure: early APM

• Registration Number: NCT05655442
• Lead Sponsor: Shenzhen People's Hospital

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.

Study Timeline

• Study Start: 2020-01-12
• Study First Submitted: 2022-12-07
• Study First Submitted QC: 2022-12-16
• Study First Posted: 2022-12-19
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-10
• Last Update Posted: 2023-03-14
• Primary Completion: 2023-07-05
• Study Completion: 2023-08-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
delayed APM	delayed APM	delayed APM within 6 and 12 month knee pain symptoms
early APM	early APM	early APM within 3 and 6 month knee pain symptoms

Primary Outcome Measures

Name	Time	Method
Kellgren-Lawrence (K/L) grade change	change from baseline up to 12 months	Kellgren-Lawrence (K/L) grade via X ray
the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) change	change from baseline up to 12 months	Te 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
the Knee Injury and Osteoarthritis Outcome Score (KOOS) change	change from baseline up to 12 months	The 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) change	change from baseline up to 12 months	The 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.

Secondary Outcome Measures

Name	Time	Method
KOOS pain score change	change from baseline up to 12 months	The 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 change	change from baseline up to 12 months	The 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 change	change from baseline up to 12 months	The 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 change	change from baseline up to 12 months	The 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 change	change from baseline up to 12 months	The 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.