Use of Hyaluronic Acid Injection in Lateral Patellar Compression With Femoral Condylar Degenerative Changes After Arthroscopic Release
Primary Purpose
Anterior Knee Pain Syndrome
Status
Completed
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Hyaluronic acid injection
No injection of Hyaluronic acid
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Knee Pain Syndrome focused on measuring Hyaluronic acid injection, Knee Arthroscopy, lateral patellar retinaculae., lateral patellar compression syndrome
Eligibility Criteria
Inclusion Criteria:
- Lateral patellar compression syndrome
Exclusion Criteria:
- Patellar instability.
- Smoking.
- Diabetes Mellitus.
- Previous knee surgery.
Sites / Locations
- Sherwan Hamawandi
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Knee arthroscopy with Hyaluronic acid injection
Knee arthroscopy without Hyaluronic acid injection
Arm Description
Those patients who received hyaluronic acid injection
Knee arthroscopy who did not Hyaluronic acid injection
Outcomes
Primary Outcome Measures
Visual analogue score of knee pain
Visual analogue score of knee pain describe knee pain from degree 0 where no pain to degree 10 where is severe pain
Kujala score
Kujala score questionnaire up to 100
Secondary Outcome Measures
Full Information
NCT ID
NCT04134611
First Posted
October 17, 2019
Last Updated
June 8, 2020
Sponsor
Hawler Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04134611
Brief Title
Use of Hyaluronic Acid Injection in Lateral Patellar Compression With Femoral Condylar Degenerative Changes After Arthroscopic Release
Official Title
Use of Hyaluronic Acid Injection After Arthroscopic Lateral Release in Patellar Compression Syndrome With Degenerative Cartilage Changes: Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
March 10, 2020 (Actual)
Study Completion Date
March 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hawler Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Knee Pain Syndrome
Keywords
Hyaluronic acid injection, Knee Arthroscopy, lateral patellar retinaculae., lateral patellar compression syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Knee arthroscopy with Hyaluronic acid injection
Arm Type
Active Comparator
Arm Description
Those patients who received hyaluronic acid injection
Arm Title
Knee arthroscopy without Hyaluronic acid injection
Arm Type
Active Comparator
Arm Description
Knee arthroscopy who did not Hyaluronic acid injection
Intervention Type
Device
Intervention Name(s)
Hyaluronic acid injection
Intervention Description
Injection of Hyaluronic acid in knees of those who has degenerative changes after arthroscopic treatment of lateral patellar compression syndrome
Intervention Type
Device
Intervention Name(s)
No injection of Hyaluronic acid
Intervention Description
No injection of Hyaluronic acid was done
Primary Outcome Measure Information:
Title
Visual analogue score of knee pain
Description
Visual analogue score of knee pain describe knee pain from degree 0 where no pain to degree 10 where is severe pain
Time Frame
The VAS for knee pain was measured 24 months after operation
Title
Kujala score
Description
Kujala score questionnaire up to 100
Time Frame
Preoperative assessment and 2 year postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
26 Years
Maximum Age & Unit of Time
47 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Lateral patellar compression syndrome
Exclusion Criteria:
Patellar instability.
Smoking.
Diabetes Mellitus.
Previous knee surgery.
Facility Information:
Facility Name
Sherwan Hamawandi
City
Erbil
ZIP/Postal Code
44001
Country
Iraq
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
33407337
Citation
Hamawandi SA. Use of hyaluronic acid injection after arthroscopic release in lateral patellar compression syndrome with degenerative cartilage changes: randomized control trial. BMC Musculoskelet Disord. 2021 Jan 6;22(1):24. doi: 10.1186/s12891-020-03876-0.
Results Reference
derived
Learn more about this trial
Use of Hyaluronic Acid Injection in Lateral Patellar Compression With Femoral Condylar Degenerative Changes After Arthroscopic Release
We'll reach out to this number within 24 hrs