Arthroscopic Partial Meniscectomy Time Window

Sponsor
Shenzhen People's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05655442
Collaborator
(none)
90
1
2
36.5
2.5

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase
  • Procedure: early APM
  • Procedure: delayed APM
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Early vs Delayed Arthroscopic Partial Meniscectomy on the Knee Function of Patients With Degenerative Meniscus Lesions
Actual Study Start Date :
Jan 12, 2020
Anticipated Primary Completion Date :
Jan 5, 2023
Anticipated Study Completion Date :
Jan 28, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: early APM

early APM within 3 and 6 month knee pain symptoms

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

Active Comparator: delayed APM

delayed APM within 6 and 12 month knee pain symptoms

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

Outcome Measures

Primary Outcome Measures

  1. 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)

  2. 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.

  3. Kellgren-Lawrence (K/L) grade change [change from baseline up to 12 months]

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

  4. 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

Secondary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 70 Years
Sexes Eligible for Study:
All
Accepts 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;

Contacts and Locations

Locations

Site City State Country Postal Code
1 First Affiliated Hospital of Jinzhou Medical University Jinzhou Liaoning China 121000

Sponsors and Collaborators

  • Shenzhen People's Hospital

Investigators

  • Principal Investigator: Hongyu Wang, Doctor, Shenzhen People's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shenzhen People's Hospital
ClinicalTrials.gov Identifier:
NCT05655442
Other Study ID Numbers:
  • SZlesions
First Posted:
Dec 19, 2022
Last Update Posted:
Dec 19, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Dec 19, 2022