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Physical Therapy vs Arthroscopic Partial Meniscectomy

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05655429
Enrollment
120
Registered
2022-12-19
Start date
2020-01-15
Completion date
2023-08-10
Last updated
2023-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Medial Meniscus Tears

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.

Interventions

PROCEDUREphysical therapy

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

Arthroscopic partial meniscectomy surgery procedure

Sponsors

Shenzhen People's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frameDescription
Kellgren-Lawrence (K/L) grade changechange from baseline up to 12 monthsKellgren-Lawrence (K/L) grade
serum triglycerides (TG) changechange from baseline up to 12 monthsserum triglycerides (TG) (mmol/L)
low-density lipoprotein cholesterol (LDL-C) changechange from baseline up to 12 monthsserum low-density lipoprotein cholesterol (LDL-C) (mmol/L)
high-density lipoprotein cholesterol (HDL-C) changechange from baseline up to 12 monthsserum high-density lipoprotein cholesterol (HDL-C) (mmol/L)
fast blood glucose(FBG) changechange from baseline up to 12 monthsserum fast blood glucose(FBG) (mmol/L)
Body mass index changechange from baseline up to 12 monthsBody mass index(BMI) weight/height square (kg/㎡)
the Knee Injury and Osteoarthritis Outcome Score (KOOS) changechange from baseline up to 12 monthsThe 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)
the International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC Score) changechange from baseline up to 12 monthsThe 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.
waist circumstance changechange from baseline up to 12 monthswaist circumstance (cm)
systolic blood pressure changechange from baseline up to 12 monthssystolic blood pressure /mmHg
diastolic blood pressure changechange from baseline up to 12 monthsdiastolic blood pressure/mmHg
serum total cholesterol (TC) changechange from baseline up to 12 monthsserum total cholesterol (TC) (mmol/L)

Secondary

MeasureTime frameDescription
symptoms score changechange from baseline up to 12 monthsThe 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.
activities of daily living score changechange from baseline up to 12 monthsThe 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
function in sport and recreation score changechange from baseline up to 12 monthsThe 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
knee related quality of life score changechange from baseline up to 12 monthsThe 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
pain score changechange from baseline up to 12 monthsThe 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.

Countries

China

Contacts

Primary ContactHongyu Wang, Doctor
wanghongyu790039663@126.com18241651300

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026