Arthroscopic Partial Meniscectomy Time Window

Meniscus Lesion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05655442
• Other study ID #: SZlesions
• Status: Withdrawn
• Phase: N/A
• Start date: January 12, 2020
• Est. completion date: August 28, 2023

Study information

• Verified date: March 2023
• Source: Shenzhen People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 28, 2023
• Est. primary completion date: July 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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;

Related Conditions & MeSH terms

• Meniscus Lesion

Intervention

Procedure:
• early APM
early APM within 3 and 6 month knee pain symptoms
• delayed APM
delayed APM within 6 and 12 month knee pain symptoms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the Knee Injury and Osteoarthritis Outcome Score (KOOS) change	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)	change from baseline up to 12 months
Primary	International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC Score) change	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.	change from baseline up to 12 months
Primary	Kellgren-Lawrence (K/L) grade change	Kellgren-Lawrence (K/L) grade via X ray	change from baseline up to 12 months
Primary	the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) change	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	change from baseline up to 12 months
Secondary	KOOS pain score change	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.	change from baseline up to 12 months
Secondary	KOOS symptoms score change	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.	change from baseline up to 12 months
Secondary	KOOS activities of daily living score change	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.	change from baseline up to 12 months
Secondary	KOOS function in sport and recreation score change	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.	change from baseline up to 12 months
Secondary	KOOS knee related quality of life score change	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.	change from baseline up to 12 months