- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04134611
Use of Hyaluronic Acid Injection in Lateral Patellar Compression With Femoral Condylar Degenerative Changes After Arthroscopic Release
June 8, 2020 updated by: Sherwan Ahmed Ali Hamawandi, Hawler Medical University
Use of Hyaluronic Acid Injection After Arthroscopic Lateral Release in Patellar Compression Syndrome With Degenerative Cartilage Changes: Randomized Control Trial
Ninety patients are involved in this study, who underwent arthroscopic lateral patellar release for lateral patellar compression syndrome and they had patellofemoral degenerative lesion, which diagnoses by MRI preoperatively and proved by arthroscopic examination to be early stages of degenerative changes with no loss of articular surface.
The patients were divided in to two groups (A and B).
Group A (45 patients) were treated by local injection of Hyaluronic acid intraarticularly, and Group B (45 patients) were no injection intraarticular.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study was done by one orthopedic surgeon in two hospitals.
Ninety patients are involved in this study, who underwent arthroscopic lateral patellar release for lateral patellar compression syndrome and they had patellofemoral degenerative lesion, which diagnoses by MRI preoperatively and proved by arthroscopic examination to be early stages of degenerative changes with no loss of articular surface.
The patients were divided in to two matched groups (A and B) regarding the age and gender; Group A (45 patients) were treated by local injection of Hyaluronic acid intraarticularly, 2 weeks after arthroscopy and were followed by VAS of knee pain for one year at (3) months, (6) months and (12) months, and Group B (45 patients) were no injection intraarticular.
The study started on June (2017) and ends on March (2020).
injection of Hyaluronic acid was used and followed in the same way.
All patients presented with anterior knee pain which failed to respond to conservative treatment for 6 weeks or recurrent of symptoms after stopping of conservative treatment which involved changes of life style and NSAID.
MRI done for all patients before operation.
Study Type
Interventional
Enrollment (Actual)
90
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
26 years to 47 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Lateral patellar compression syndrome
Exclusion Criteria:
- Patellar instability.
- Smoking.
- Diabetes Mellitus.
- Previous knee surgery.
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 |
---|---|
Active Comparator: Knee arthroscopy with Hyaluronic acid injection
Those patients who received hyaluronic acid injection
|
Injection of Hyaluronic acid in knees of those who has degenerative changes after arthroscopic treatment of lateral patellar compression syndrome
|
Active Comparator: Knee arthroscopy without Hyaluronic acid injection
Knee arthroscopy who did not Hyaluronic acid injection
|
No injection of Hyaluronic acid was done
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual analogue score of knee pain
Time Frame: The VAS for knee pain was measured 24 months after operation
|
Visual analogue score of knee pain describe knee pain from degree 0 where no pain to degree 10 where is severe pain
|
The VAS for knee pain was measured 24 months after operation
|
Kujala score
Time Frame: Preoperative assessment and 2 year postoperatively
|
Kujala score questionnaire up to 100
|
Preoperative assessment and 2 year postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
June 1, 2017
Primary Completion (Actual)
March 10, 2020
Study Completion (Actual)
March 20, 2020
Study Registration Dates
First Submitted
October 17, 2019
First Submitted That Met QC Criteria
October 18, 2019
First Posted (Actual)
October 22, 2019
Study Record Updates
Last Update Posted (Actual)
June 11, 2020
Last Update Submitted That Met QC Criteria
June 8, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HMU/Sherwan6
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
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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