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Clinical Trials/NCT05655442
NCT05655442
Withdrawn
Not Applicable

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

Shenzhen People's Hospital0 sitesJanuary 12, 2020
ConditionsMeniscus Lesion

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Meniscus Lesion
Sponsor
Shenzhen People's Hospital
Primary Endpoint
Kellgren-Lawrence (K/L) grade change
Status
Withdrawn
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 12, 2020
End Date
August 28, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Shenzhen People's Hospital
Responsible Party
Sponsor

Eligibility Criteria

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;

Outcomes

Primary Outcomes

Kellgren-Lawrence (K/L) grade change

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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 Outcomes

  • KOOS pain score change(change from baseline up to 12 months)
  • KOOS symptoms score change(change from baseline up to 12 months)
  • KOOS activities of daily living score change(change from baseline up to 12 months)
  • KOOS function in sport and recreation score change(change from baseline up to 12 months)
  • KOOS knee related quality of life score change(change from baseline up to 12 months)

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