Anterior Knee Pain SyndromeNCT04134611
Use of Hyaluronic Acid Injection in Lateral Patellar Compression With Femoral Condylar Degenerative Changes After Arthroscopic Release
A study testing Hyaluronic acid injection and No injection of Hyaluronic acid in people with Anterior Knee Pain Syndrome, run by Hawler Medical University at 1 site in Iraq.
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… Read more about this study
- Who is it for?
- Ages 26 to 47 years
- Conditions the study is for
- Anterior Knee Pain Syndrome
- What is being tested?
- Hyaluronic acid injection and No injection of Hyaluronic acid
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIraq
- Study dates
- 1 Jun 2017to 20 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 to 47 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Lateral patellar compression syndrome
Who cannot join
- Patellar instability.
- Smoking.
- Diabetes Mellitus.
- Previous knee surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anterior Knee Pain Syndrome
- Being tested
- Hyaluronic acid injection, No injection of Hyaluronic acid
- Keywords
- Hyaluronic acid injection, Knee Arthroscopy, lateral patellar retinaculae., lateral patellar compression syndrome
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acid injectionDevice
Injection of Hyaluronic acid in knees of those who has degenerative changes after arthroscopic treatment of lateral patellar compression syndrome
No injection of Hyaluronic acidDevice
No injection of Hyaluronic acid was done
| Study group | Role | What they receive |
|---|---|---|
| Knee arthroscopy with Hyaluronic acid injection | Active comparator | Those patients who received hyaluronic acid injection Receives: Device: Hyaluronic acid injection |
| Knee arthroscopy without Hyaluronic acid injection | Active comparator | Knee arthroscopy who did not Hyaluronic acid injection Receives: Device: No injection of Hyaluronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: The VAS for knee pain was measured 24 months after operation
Kujala score
Kujala score questionnaire up to 100
Measured: Preoperative assessment and 2 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start1 Jun 2017
- Primary completion10 Mar 2020
- Study completion20 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Knee Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hawler Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherwan Ahmed Ali Hamawandi, Hawler Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04134611
- Sponsor's protocol ID
- HMU/Sherwan6
- Status last verified
- Jun 2020
- First submitted
- 17 Oct 2019
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 33407337
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Hyaluronic Acid Injection After Arthroscopic Lateral Release in Patellar Compression Syndrome With Degenerative Cartilage Changes: Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04134611
- Acronym / sponsor ID
- HMU/Sherwan6
- Conditions
- Anterior Knee Pain Syndrome
- Keywords
- Hyaluronic acid injection, Knee Arthroscopy, lateral patellar retinaculae., lateral patellar compression syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Hawler Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 22 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Knee arthroscopy with Hyaluronic acid injection | Active comparator | Device: Hyaluronic acid injectionThose patients who received hyaluronic acid injection |
| Knee arthroscopy without Hyaluronic acid injection | Active comparator | Device: No injection of Hyaluronic acidKnee arthroscopy who did not Hyaluronic acid injection |
Who may qualify
- Ages
- 26 to 47 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Lateral patellar compression syndrome
Key exclusion criteria (4 listed)
- Patellar instability.
- Smoking.
- Diabetes Mellitus.
- Previous knee surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyaluronic acid injectionInjection of Hyaluronic acid in knees of those who has degenerative changes after arthroscopic treatment of lateral patellar compression syndrome | Device | Knee arthroscopy with Hyaluronic acid injection |
| No injection of Hyaluronic acidNo injection of Hyaluronic acid was done | Device | Knee arthroscopy without Hyaluronic acid injection |
Primary outcome
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
Kujala score
Time frame: Preoperative assessment and 2 year postoperatively
Kujala score questionnaire up to 100
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Derived from this study: PubMed 33407337Hamawandi 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic acid injection and No injection of Hyaluronic acid in people with Anterior Knee Pain Syndrome, run by Hawler Medical University at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue score of knee pain (time frame: The VAS for knee pain was measured 24 months after operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04134611, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.