NCT05655442

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)

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2020

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 19, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2023

Completed
Last Updated

March 14, 2023

Status Verified

March 1, 2023

Enrollment Period

3.5 years

First QC Date

December 7, 2022

Last Update Submit

March 10, 2023

Conditions

Meniscus Lesion

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • Kellgren-Lawrence (K/L) grade change

    Kellgren-Lawrence (K/L) grade via X ray

    change from baseline up to 12 months

  • 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 Outcomes (5)

  • 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

Study Arms (2)

early APM

EXPERIMENTAL

early APM within 3 and 6 month knee pain symptoms

Procedure: early APM

delayed APM

ACTIVE COMPARATOR

delayed APM within 6 and 12 month knee pain symptoms

Procedure: delayed APM

Interventions

early APMPROCEDURE

early APM within 3 and 6 month knee pain symptoms

early APM
delayed APMPROCEDURE

delayed APM within 6 and 12 month knee pain symptoms

delayed APM

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of degenerative meniscus lesions based on knee MRI

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Hongyu Wang, Doctor

    Shenzhen People's Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2022

First Posted

December 19, 2022

Study Start

January 12, 2020

Primary Completion

July 5, 2023

Study Completion

August 28, 2023

Last Updated

March 14, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share