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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04134611
Other study ID # HMU/Sherwan6
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2017
Est. completion date March 20, 2020

Study information

Verified date June 2020
Source Hawler Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date March 20, 2020
Est. primary completion date March 10, 2020
Accepts healthy volunteers No
Gender All
Age group 26 Years to 47 Years
Eligibility Inclusion Criteria:

- Lateral patellar compression syndrome

Exclusion Criteria:

- Patellar instability.

- Smoking.

- Diabetes Mellitus.

- Previous knee surgery.

Study Design


Intervention

Device:
Hyaluronic acid injection
Injection of Hyaluronic acid in knees of those who has degenerative changes after arthroscopic treatment of lateral patellar compression syndrome
No injection of Hyaluronic acid
No injection of Hyaluronic acid was done

Locations

Country Name City State
Iraq Sherwan Hamawandi Erbil

Sponsors (1)

Lead Sponsor Collaborator
Hawler Medical University

Country where clinical trial is conducted

Iraq, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 The VAS for knee pain was measured 24 months after operation
Primary Kujala score Kujala score questionnaire up to 100 Preoperative assessment and 2 year postoperatively
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