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Use of Hyaluronic Acid Injection in Lateral Patellar Compression With Femoral Condylar Degenerative Changes After Arthroscopic Release

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ClinicalTrials.gov Identifier: NCT04134611
Recruitment Status : Completed
First Posted : October 22, 2019
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Sherwan Ahmed Ali Hamawandi, Hawler Medical University

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.

Condition or disease Intervention/treatment Phase
Anterior Knee Pain Syndrome Device: Hyaluronic acid injection Device: No injection of Hyaluronic acid Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Hyaluronic Acid Injection After Arthroscopic Lateral Release in Patellar Compression Syndrome With Degenerative Cartilage Changes: Randomized Control Trial
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : March 10, 2020
Actual Study Completion Date : March 20, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Knee arthroscopy with Hyaluronic acid injection
Those patients who received hyaluronic acid injection
Device: 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
Device: No injection of Hyaluronic acid
No injection of Hyaluronic acid was done




Primary Outcome Measures :
  1. 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

  2. Kujala score [ Time Frame: Preoperative assessment and 2 year postoperatively ]
    Kujala score questionnaire up to 100



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Ages Eligible for Study:   26 Years to 47 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Lateral patellar compression syndrome

Exclusion Criteria:

  • Patellar instability.
  • Smoking.
  • Diabetes Mellitus.
  • Previous knee surgery.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04134611


Locations
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Iraq
Sherwan Hamawandi
Erbil, Iraq, 44001
Sponsors and Collaborators
Hawler Medical University
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Responsible Party: Sherwan Ahmed Ali Hamawandi, Assistant professor of orthopedic surgery, Hawler Medical University
ClinicalTrials.gov Identifier: NCT04134611    
Other Study ID Numbers: HMU/Sherwan6
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sherwan Ahmed Ali Hamawandi, Hawler Medical University:
Hyaluronic acid injection
Knee Arthroscopy
lateral patellar retinaculae.
lateral patellar compression syndrome
Additional relevant MeSH terms:
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Patellofemoral Pain Syndrome
Syndrome
Disease
Pathologic Processes
Joint Diseases
Musculoskeletal Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents