Physical Therapy vs Arthroscopic Partial Meniscectomy

NCT05655429 | Unknown DMC

• 1 other identifier: ShenzhenPH meniscus001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Medial Meniscus Tears

Outcome Measures

Primary Outcomes (12)

• the Knee Injury and Osteoarthritis Outcome Score (KOOS) change

  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

  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

  waist circumstance (cm)

  change from baseline up to 12 months

• systolic blood pressure change

  systolic blood pressure /mmHg

  change from baseline up to 12 months

• diastolic blood pressure change

  diastolic blood pressure/mmHg

  change from baseline up to 12 months

• serum total cholesterol (TC) change

  serum total cholesterol (TC) (mmol/L)

  change from baseline up to 12 months

• serum triglycerides (TG) change

  serum triglycerides (TG) (mmol/L)

  change from baseline up to 12 months

• low-density lipoprotein cholesterol (LDL-C) change

  serum low-density lipoprotein cholesterol (LDL-C) (mmol/L)

  change from baseline up to 12 months

• high-density lipoprotein cholesterol (HDL-C) change

  serum high-density lipoprotein cholesterol (HDL-C) (mmol/L)

  change from baseline up to 12 months

• fast blood glucose(FBG) change

  serum fast blood glucose(FBG) (mmol/L)

  change from baseline up to 12 months

• Body mass index change

  Body mass index(BMI) weight/height square (kg/㎡)

  change from baseline up to 12 months

• Kellgren-Lawrence (K/L) grade change

  Kellgren-Lawrence (K/L) grade

  change from baseline up to 12 months

Secondary Outcomes (5)

• pain score change

  change from baseline up to 12 months

• symptoms score change

  change from baseline up to 12 months

• activities of daily living score change

  change from baseline up to 12 months

• function in sport and recreation score change

  change from baseline up to 12 months

• knee related quality of life score change

  change from baseline up to 12 months

Study Arms (2)

physical therapy

EXPERIMENTAL

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

Procedure: physical therapy

arthroscopic partial meniscectomy

ACTIVE COMPARATOR

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

Procedure: arthroscopic partial meniscectomy

Interventions

physical therapy PROCEDURE

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

physical therapy

arthroscopic partial meniscectomy PROCEDURE

Arthroscopic partial meniscectomy surgery procedure

arthroscopic partial meniscectomy

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shenzhen People's Hospital: lead

Study Sites (1)

Shenzhen People's Hospital

Shenzhen, Guangdong, 121000, China

RECRUITING

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Central Study Contacts

Hongyu Wang, Doctor

CONTACT

18241651300; wanghongyu790039663@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 19, 2022
• Study Start: January 15, 2020
• Primary Completion: August 2, 2023
• Study Completion: August 10, 2023
• Last Updated: March 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)