Physical Therapy vs Arthroscopic Partial Meniscectomy

March 11, 2023 updated by: Shenzhen People's Hospital

Physical Therapy vs Arthroscopic Partial Meniscectomy on the Knee Function of Metabolic Syndrome Patients With Degenerative Meniscus Lesions

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 121000
        • Recruiting
        • Shenzhen People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: physical therapy
Physical therapy mainly include aerobic exercises and resistance exercise, flexibility exercises about 150 minutes for ≥2 d/week for 6 months.
Procedure: physical therapy
The exercise intervention included aerobic exercises and resistance exercise, flexibility exercises about 150 minutes for ≥2 day per week.
Active Comparator: arthroscopic partial meniscectomy
The torn meniscus and unstable part were removed with arthroscopic instruments.
Procedure: arthroscopic partial meniscectomy
Arthroscopic partial meniscectomy surgery procedure

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
the Knee Injury and Osteoarthritis Outcome Score (KOOS) change
Time Frame: 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)
change from baseline up to 12 months
the International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC Score) change
Time Frame: 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.
change from baseline up to 12 months
waist circumstance change
Time Frame: change from baseline up to 12 months
waist circumstance (cm)
change from baseline up to 12 months
systolic blood pressure change
Time Frame: change from baseline up to 12 months
systolic blood pressure /mmHg
change from baseline up to 12 months
diastolic blood pressure change
Time Frame: change from baseline up to 12 months
diastolic blood pressure/mmHg
change from baseline up to 12 months
serum total cholesterol (TC) change
Time Frame: change from baseline up to 12 months
serum total cholesterol (TC) (mmol/L)
change from baseline up to 12 months
serum triglycerides (TG) change
Time Frame: change from baseline up to 12 months
serum triglycerides (TG) (mmol/L)
change from baseline up to 12 months
low-density lipoprotein cholesterol (LDL-C) change
Time Frame: change from baseline up to 12 months
serum low-density lipoprotein cholesterol (LDL-C) (mmol/L)
change from baseline up to 12 months
high-density lipoprotein cholesterol (HDL-C) change
Time Frame: change from baseline up to 12 months
serum high-density lipoprotein cholesterol (HDL-C) (mmol/L)
change from baseline up to 12 months
fast blood glucose(FBG) change
Time Frame: change from baseline up to 12 months
serum fast blood glucose(FBG) (mmol/L)
change from baseline up to 12 months
Body mass index change
Time Frame: change from baseline up to 12 months
Body mass index(BMI) weight/height square (kg/㎡)
change from baseline up to 12 months
Kellgren-Lawrence (K/L) grade change
Time Frame: change from baseline up to 12 months
Kellgren-Lawrence (K/L) grade
change from baseline up to 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
pain score change
Time Frame: 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.
change from baseline up to 12 months
symptoms score change
Time Frame: 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.
change from baseline up to 12 months
activities of daily living score change
Time Frame: 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
change from baseline up to 12 months
function in sport and recreation score change
Time Frame: 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
change from baseline up to 12 months
knee related quality of life score change
Time Frame: 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
change from baseline up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shenzhen People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 2, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 10, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ShenzhenPH meniscus001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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