Clinical trial NCT05114694: Early Arthroscopic Partial Meniscectomy(APM)
Official title: Consultant of Shenzhen People's Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Meniscus Tear
Lead sponsor: The First People's Hospital of Jingzhou
Sponsor class: OTHER
First posted: 2021-11-10
Enrollment: 120
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Arthroscopic partial meniscectomy(APM) surgery outcomes for Metabolic Syndrome(MetS) patients with degenerative meniscus tears(DMTs) was still not clear. The aim of the study was to investigate outcomes of early APM vs delayed APM for MetS patients with degenerate meniscus tears.

Detailed description: Degenerate meniscus tears(DMTs) were the most common knee disease in aged and obese people. The most common treatment for DMTs was arthroscopic partial meniscectomy(APM) surgery. However, the time window for performing APM surgery was unclear, especially in obese patients with Metabolic syndrome(MetS). Abdominal obesity, insulin resistance with or without glucose intolerance, dyslipidemia or elevated blood pressure are included in the principal components of MetS. Whether early APM within 3 to 6 months or delayed APM surgery within 6 to 12 months are benefical to MetS patients with DMTs. The knee function outcomes between early APM and delayed APM for MetS patients with DMTs were assessed and follow up to 12 months after surgery.

Eligibility criteria: Inclusion Criteria:

* • Must be age between 35 and 70 years old;

  * Clinical diagnosis of metabolic syndrome;
  * Clinical diagnosis of degnerate meniscus tears;

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;

Primary outcomes:
measure: Knee KOOS score
timeFrame: up to 12 month
measure: IKDC score
timeFrame: up to 12 month
measure: waist circumstance
timeFrame: at baseline
measure: SBP
timeFrame: at baseline
measure: DBP
timeFrame: at baseline
measure: TC
timeFrame: at baseline
measure: TG
timeFrame: at baseline
measure: LDL
timeFrame: at baseline
measure: HDL
timeFrame: at baseline
measure: FBG
timeFrame: at baseline
measure: BMI
timeFrame: at baseline
measure: K-L grade
timeFrame: at baseline
Secondary outcomes:
measure: pain score
timeFrame: up to 12 month
measure: symptoms score
timeFrame: up to 12 month
measure: activities of daily living score
timeFrame: up to 12 month
measure: function in sport and recreation score
timeFrame: up to 12 month
measure: knee related quality of life score
timeFrame: up to 12 month
Other outcomes:
Locations:
city: Jinzhou
country: China
facility: First Affiliated Hospital of Jinzhou Medical University
state: Liaoning
Study officials:
References: