Physical Therapy vs Arthroscopic Partial Meniscectomy

NCT ID: NCT05655429

Last Updated: 2023-03-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-15
• Study Completion Date: 2023-08-10

Brief Summary

The purpose was to assess knee function outcomes between physical therapy and arthroscopic partial menisectomy(APM) for Metabolic syndrome(MetS) patients with degenerative meniscus lesions(DMLs) during 12 month follow up.

Detailed Description

Metabolic syndrome were diagnosed with abdominal obesity, insulin resistance with or without glucose intolerance, dyslipidemia or elevated blood pressure and widely prevalence all around the world.MetS patients were always correlated with knee osteoarthritis or cartilage volume loss. For MetS patients with DMLs, whether physical therapy was non-inferior to APM in knee function and MetS components was unknown.

Conditions

Knee Medial Meniscus Tears

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

physical therapy

Physical therapy mainly include aerobic exercises and resistance exercise, flexibility exercises about 150 minutes for ≥2 d/week for 6 months.

Group Type: EXPERIMENTAL

physical therapy

Intervention Type: PROCEDURE

The exercise intervention included aerobic exercises and resistance exercise, flexibility exercises about 150 minutes for ≥2 day per week.

arthroscopic partial meniscectomy

The torn meniscus and unstable part were removed with arthroscopic instruments.

Group Type: ACTIVE_COMPARATOR

arthroscopic partial meniscectomy

Intervention Type: PROCEDURE

Arthroscopic partial meniscectomy surgery procedure

Interventions

physical therapy

The exercise intervention included aerobic exercises and resistance exercise, flexibility exercises about 150 minutes for ≥2 day per week.

Intervention Type: PROCEDURE

arthroscopic partial meniscectomy

Arthroscopic partial meniscectomy surgery procedure

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Must be age between 35 and 70 years old;

• Clinical diagnosis of metabolic syndrome;
• Clinical diagnosis of degenerative meniscus lesions;
• Patients who has knee pain history
• Knee symptoms consistent with DMLs verified on MRI
• eligible for arthroscopic partial meniscectomy surgery by the examining orthopedic surgeons.

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;

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shenzhen People's Hospital

Shenzhen, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hongyu Wang, Doctor

Role: CONTACT

wanghongyu790039663@126.com

18241651300

Facility Contacts

Yu Luo, Master

Role: primary

zhzm622@163.com

18841609587

Other Identifiers

ShenzhenPH meniscus001

Identifier Type: -

Identifier Source: org_study_id