- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04313569
Arthroscopic Versus Conservative Treatment of Degenerative Meniscal Tear in Middle Aged Patients in Regard to Pain & Knee Function
March 18, 2020 updated by: Sherwan Ahmed Ali Hamawandi, Hawler Medical University
Arthroscopic Versus Conservative Treatment of Degenerative Meniscal Tear in Middle Aged Patients in Regard to Pain & Knee Function: Comparative Study
The study is prospective comparative study, conducted in Erbil teaching hospital on 60 patients, their age ranging between 40 and 60 years.
All were clinically diagnosed to have degenerative medial meniscal tear then confirmed by MRI.
Thirty patients were treated conservatively, thirty patients were treated arthroscopically.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- 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 Locations
-
-
-
Erbil, Iraq, 44001
- Sherwan Hamawandi
-
-
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
Ages Eligible for Study
40 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Atraumatic continuous pain in medial aspect of knee affecting daily activities, for more than one month despite the treatment of general physician.
- Grade 3 degenerative tear of medial meniscus approved on MRI.
Exclusion Criteria:
- Meniscal tear due to trauma.
- Any rheumatologic knee disease.
- MRI showing ligament injury, loose bodies, tumors and osteochondral defects.
- Former surgery of knee and lower limb fractures in the last year.
- Knee joints with osteoarthritis graded 2 or more according to Kellgren-Lawrence scale (Kellgren and Lawrence, 1957) on weight-bearing knee x-ray.
- Lateral meniscus tear.
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Conservative treatment
Use of medications, like analgesic, muscle relaxants, non-steroidal anti-inflammatory drugs (NSAID) and local painkillers, depending on the patient condition, and physiotherapy, lifestyle and daily activity modification, patient education about positioning of the knee
|
|
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Other: Arthroscopic menisctomy
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Arthroscopic medial menisctomy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lysholm Knee Scoring Scale
Time Frame: All patients were reviewed and evaluated one year, by Lysholm score
|
Lysholm Knee score scale has (8) parts (swelling, pain, squatting, support, stair climbing, limping, locking and instability).
Score of 100 means no problems in knee.
|
All patients were reviewed and evaluated one year, by Lysholm score
|
|
Visual analogue score
Time Frame: All patients were reviewed and evaluated one year, by Visual Analogue score scales
|
Ten points Visual Analogue Score scale used in order to meassure the severity of knee pain during the study.
Zero meaning no pain while 10 meaning the most severe pain
|
All patients were reviewed and evaluated one year, by Visual Analogue score scales
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
August 1, 2017
Primary Completion (Actual)
September 1, 2019
Study Completion (Actual)
September 30, 2019
Study Registration Dates
First Submitted
March 16, 2020
First Submitted That Met QC Criteria
March 17, 2020
First Posted (Actual)
March 18, 2020
Study Record Updates
Last Update Posted (Actual)
March 20, 2020
Last Update Submitted That Met QC Criteria
March 18, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HMU/Sherwan9
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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