Early Arthroscopic Partial Meniscectomy(APM)

• Sponsor: The First People's Hospital of Jingzhou (Other)
• Overall Status: Completed
• CT.gov ID: NCT05114694
• Collaborator: (none)
• Enrollment: 81
• Location: 1
• Arms: 2
• Actual Duration (Months): 45.3
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

Arthroscopic partial meniscectomy(APM) surgery outcomes for Metabolic Syndrome(MetS) patients with degenerative meniscus tears(DMTs) was still not clear. In the study, MetS patients with DMTs knee function outcomes of early APM vs delayed APM were assessed.

Condition or Disease	Intervention/Treatment	Phase
Meniscus Tear	Procedure: early APM; Procedure: delayed APM	N/A

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 and over half a million surgeries are performed annually in the USA. However, the outcomes of APM surgery were much better in traumatic meniscus tear than DMTs, and whether early APM or delayed APM surgery can be better for DMTs was still unknown, 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, and widely prevalence in China and all around the world. MetS were associated with knee osteoarthritis or bone marrow lesion and cartilage volume loss. However, relationship between DMTs and MetS was less explored. APM surgery outcomes for MetS patients with DMTs and whether early APM or delayed APM surgery were more benefit for MetS patients were unknown.

Study Design

• Study Type: Interventional
• Actual Enrollment: 81 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Consultant of Shenzhen People's Hospital
• Actual Study Start Date: Jan 15, 2018
• Actual Primary Completion Date: Oct 20, 2021
• Actual Study Completion Date: Oct 25, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: early APM Early APM group were patients have knee syndrome within 3 to 6 months	Procedure: early APM; Early APM group were patients have knee syndrome within 3 to 6 months; Other Names: Early arthroscopic partial meniscectomy
Placebo Comparator: delayed APM delayed APM group recruit participants who received delayed APM surgery with symptoms delayed for more than 6 months	Procedure: delayed APM; delayed APM group recruit participants who received delayed APM surgery with symptoms delayed for more than 6 months.; Other Names: delayed arthroscopic partial meniscectomy

Outcome Measures

Primary Outcome Measures

1. Knee KOOS score [up to 12 month]

   The KOOS was a self-administered outcome questionnaire has been validated in individuals undergoing APM surgery,with 0(extreme knee problem) to 100 points(the best possible score, no knee problems)

2. IKDC score [up to 12 month]

   The IKDC was a questionnaire that has high reliability and validity for middle to older patients with a meniscal tear,with 0(extreme knee problem) to 100 points(the best possible score, no knee problems)

3. waist circumstance [at baseline]

   midway between the lowest rib and the iliac crest, using an anthropometric tape

4. SBP [at baseline]

   systolic blood pressure

5. DBP [at baseline]

   diastolic blood pressure

6. TC [at baseline]

   serum total cholesterol (TC)

7. TG [at baseline]

   serum triglycerides (TG)

8. LDL [at baseline]

   serum low-density lipoprotein cholesterol (LDL-C)

9. HDL [at baseline]

   serum high-density lipoprotein cholesterol (HDL-C)

10. FBG [at baseline]

    serum fast blood glucose(FBG)

11. BMI [at baseline]

    BMI, calculated as weight in kilograms divided by height in meters squaredBMI in kg/m^2

12. K-L grade [at baseline]

    Kellgren-Lawrence (K/L) grade

Secondary Outcome Measures

1. pain score [up to 12 month]

   The KOOS subscales for pain,with 0(extreme knee problem) to 100 points(the best possible score, no knee problems)

2. symptoms score [up to 12 month]

   The KOOS subscales for symptoms,with 0(extreme knee problem) to 100 points(the best possible score, no knee problems)

3. activities of daily living score [up to 12 month]

   The KOOS subscales for activities of daily living,with 0(extreme knee problem) to 100 points(the best possible score, no knee problems)

4. function in sport and recreation score [up to 12 month]

   The KOOS subscales for function in sport and recreation,with 0(extreme knee problem) to 100 points(the best possible score, no knee problems)

5. knee related quality of life score [up to 12 month]

   The KOOS subscales for knee related quality of life,with 0(extreme knee problem) to 100 points(the best possible score, no knee problems)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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;

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

• The First People's Hospital of Jingzhou

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hongyu Wang, chief residents, Shenzhen People's Hospital
• ClinicalTrials.gov Identifier: NCT05114694
• Other Study ID Numbers: APM TIME
• First Posted: Nov 10, 2021
• Last Update Posted: Nov 10, 2021
• Last Verified: Nov 1, 2021

• 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 Nov 10, 2021