Physical Therapy vs Arthroscopic Partial Meniscectomy

• Sponsor: Shenzhen People's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05655429
• Collaborator: (none)
• Enrollment: 71
• Location: 1
• Arms: 2
• Actual Duration (Months): 35.8
• Patients Per Site Per Month: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Medial Meniscus Tears	Procedure: physical therapy; Procedure: arthroscopic partial meniscectomy	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 71 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Physical Therapy vs Arthroscopic Partial Meniscectomy on the Knee Function of Metabolic Syndrome Patients With Degenerative Meniscus Lesions
• Actual Study Start Date: Jan 15, 2020
• Actual Primary Completion Date: Jan 2, 2023
• Actual Study Completion Date: Jan 10, 2023

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. the Knee Injury and Osteoarthritis Outcome Score (KOOS) change [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)

2. the International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC Score) change [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.

3. waist circumstance change [change from baseline up to 12 months]

   waist circumstance (cm)

4. systolic blood pressure change [change from baseline up to 12 months]

   systolic blood pressure /mmHg

5. diastolic blood pressure change [change from baseline up to 12 months]

   diastolic blood pressure/mmHg

6. serum total cholesterol (TC) change [change from baseline up to 12 months]

   serum total cholesterol (TC) (mmol/L)

7. serum triglycerides (TG) change [change from baseline up to 12 months]

   serum triglycerides (TG) (mmol/L)

8. low-density lipoprotein cholesterol (LDL-C) change [change from baseline up to 12 months]

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

9. high-density lipoprotein cholesterol (HDL-C) change [change from baseline up to 12 months]

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

10. fast blood glucose(FBG) change [change from baseline up to 12 months]

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

11. Body mass index change [change from baseline up to 12 months]

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

12. Kellgren-Lawrence (K/L) grade change [change from baseline up to 12 months]

    Kellgren-Lawrence (K/L) grade

Secondary Outcome Measures

1. pain score change [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.

2. symptoms score change [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.

3. activities of daily living score change [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

4. function in sport and recreation score change [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

5. knee related quality of life score change [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

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 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;

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

• Shenzhen People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shenzhen People's Hospital
• ClinicalTrials.gov Identifier: NCT05655429
• Other Study ID Numbers: ShenzhenPH meniscus001
• First Posted: Dec 19, 2022
• Last Update Posted: Jan 18, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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 Jan 18, 2023