- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04925726
Rehabilitation After Arthroscopic Partial Meniscectomy
Water-Based vs. Land-Based Rehabilitation After Arthroscopic Partial Meniscectomy in Middle-Aged Active Patients With a Degenerative Meniscal Tear: A Randomized, Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Afyon
-
Merkez, Afyon, Turkey, 0300
- Hilal Yeşil
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: The inclusion criteria comprised a non-locked painful knee of more than 1 month, age between 35-50 years, a clinical history and examination compatible with degenerative meniscus, positive findings of a degenerative meniscal tear visible with magnetic resonance imaging (MRI), no response to nonoperative treatment of at least 3 months after onset of symptoms, and no evidence of advanced osteoarthritis (OA) on X-rays or MRI
Exclusion Criteria: The exclusion criteria employed were advanced knee OA, systemic inflammatory disease, a concurrent tear of posterior cruciate ligament, a concurrent collateral ligament repair, other problems causing knee pain (e.g., hip and ankle pathologies), a history of cardiopulmonary disease that could limit isokinetic and functional testing, an unstable medical condition, a serious cognitive deficit, a psychiatric problem, no capacity for independent walking and standing, an open wound on the skin, or pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Land based exercise
|
The patients who had land based exercise
|
|
Active Comparator: Water based exercise
|
The patients who had water based exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline VAS (visual analog scale) at 4th and 8th week
Time Frame: up to 8 weeks
|
The patients were asked to make an assesment of their pain level between 0 and 10 scale
|
up to 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline isokinetic muscle strength at 4th and 8th week
Time Frame: up to 8 weeks
|
Isokinetic knee extensor muscle strength of the patients was measured with an isokinetic dynamometer.
The test was repeated 10 times at the velocity of 60°/second and 180°/second and peak torque (Nm) measurements were recorded .
|
up to 8 weeks
|
|
Change from baseline quality of life (short form 36) at 4th and 8th week
Time Frame: up to 8 weeks
|
The physical and mental health summary scores were the primary components used.
Scoring is on a scale of 0 to 100 and a higher score reflects better health-related quality of life.
|
up to 8 weeks
|
|
Change from baseline Single-leg hop test at 4th and 8th week
Time Frame: up to 8 weeks
|
The patient stands on one foot with the big toe touching a line marked on the floor.
The participant asked to hop forward as far as possible using the same leg with their arms swing freely on both sides of the body.
Distance is measured from the starting point to the heel of the landing leg.
|
up to 8 weeks
|
|
Change from baseline Lysholm questionnaire at 4th and 8th week
Time Frame: up to 8 weeks
|
Eight subtitles are scored differently (limping or use of support: 5 points, locking sensation: 15 points, joint instability and pain: 25 points, swelling: 10 points, stair climbing: 10 points, and squatting: 5 points).
The highest and optimal total score is 100 points
|
up to 8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Murat Yesil, MD, Afyonkarahisar Health Sciences University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MYHY
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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