Knee OsteoarthritisNCT06514716
Intra-articular Corticosteroid Injection in GAE for Knee Knee Osteoarthritis
A study testing Geniculate Artery Embolization with Intra-articular Corticosteroid Injection (GAE with IACI) and Geniculate Artery Embolization alone (GAE alone) in people with Knee Osteoarthritis and Pain, Musculoskeletal, run by Zagazig University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to investigate the effectiveness and safety of intra-articular corticosteroid injection (IACI) in alleviating post-procedural pain and improving early outcomes in patients undergoing geniculate artery embolization (GAE) for knee osteoarthritis (OA). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Knee Osteoarthritis, Pain, Musculoskeletal
- What is being tested?
- Geniculate Artery Embolization with Intra-articular Corticosteroid Injection (GAE with IACI) and Geniculate Artery Embolization alone (GAE alone)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Sep 2024to 30 May 2025
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years and older
- Diagnosed with knee osteoarthritis (OA) based on clinical and radiographic criteria.
- Eligible for geniculate artery embolization (GAE) as determined by the treating physician.
- Able to provide informed consent and comply with the study protocol.
Who cannot join
- Contraindications to corticosteroid injections or geniculate artery embolization.
- Pregnant or breastfeeding women.
- Active infection or skin condition at the injection site.
- Severe cardiovascular, renal, or hepatic diseases that may affect study participation.
- Previous knee surgery within the last 6 months.
- Participation in another clinical trial within the last 30 days.
- Inability to comply with follow-up visits or complete study assessments.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Zagazig University, Faculty of Medicine
Zagazig, 44519
Ahmed A Bessar, MD, PhD
About this study
Official title: Role of Intra-articular Corticosteroid Injection in Geniculate Artery Embolization for Knee Osteoarthritis: A Comparative Study
The goal of this clinical trial is to investigate the effectiveness and safety of intra-articular corticosteroid injection (IACI) in alleviating post-procedural pain and improving early outcomes in patients undergoing geniculate artery embolization (GAE) for knee osteoarthritis (OA). The main questions it aims to answer are:
- Does intra-articular corticosteroid injection reduce pain levels post-procedure compared to GAE alone?
- Does the combination of GAE and IACI improve functional outcomes and patient-reported outcomes compared to GAE alone?
Read more
Investigators will compare patients receiving GAE with IACI to those receiving GAE alone to see if the addition of IACI provides superior pain relief and functional improvement.
Participants will:
- Undergo geniculate artery embolization, with or without intra-articular corticosteroid injection.
- Have their pain levels assessed using the Visual Analog Scale (VAS) at 1 week, 2 weeks, and 4 weeks post-procedure.
- Complete functional outcome assessments using the KOOS and WOMAC scores.
- Report any adverse events throughout the study period.
Read the detailed description
This study is a prospective, randomized, comparative trial designed to evaluate the role of intra-articular corticosteroid injection (IACI) in patients undergoing geniculate artery embolization (GAE) for knee osteoarthritis (OA). The trial will enroll adult participants diagnosed with knee OA who are eligible for GAE.
Participants will be randomized into two groups: Group A (GAE with IACI) and Group B (GAE alone). The primary outcome measure will be the Visual Analog Scale (VAS) pain scores at 1 week, 2 weeks, and 4 weeks post-procedure. Secondary outcome measures will include functional improvement assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS) and the Western Ontario and McMaster Universities Arthritis Index (WOMAC), patient-reported outcomes, and the incidence of adverse events.
The study aims to determine whether the addition of IACI to GAE provides better pain relief and functional outcomes compared to GAE alone. Data will be collected at baseline and specified time points post-procedure, and statistical analysis will be conducted to compare the outcomes between the two groups. This study is conducted in accordance with the principles of the Declaration of Helsinki and has received ethical approval from the institutional review board. Informed consent will be obtained from all participants before enrollment.
- Conditions
- Knee Osteoarthritis, Pain, Musculoskeletal
- Being tested
- Geniculate Artery Embolization with Intra-articular Corticosteroid Injection (GAE with IACI), Geniculate Artery Embolization alone (GAE alone)
- Keywords
- Geniculate Artery Embolization, Intra-articular Corticosteroid Injection, Pain Relief, Functional Improvement
- Medical subject headings
- Osteoarthritis, Knee, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geniculate Artery Embolization with Intra-articular Corticosteroid Injection (GAE with IACI)Procedure or surgery
Participants will undergo geniculate artery embolization (GAE) followed by an intraoperative intra-articular corticosteroid injection (IACI). This combination aims to alleviate post-procedural pain and improve early functional outcomes in patients with knee osteoarthritis (OA).
Geniculate Artery Embolization alone (GAE alone)Procedure or surgery
Participants will undergo geniculate artery embolization (GAE) without the additional intraoperative intra-articular corticosteroid injection. This procedure aims to serve as a control to evaluate the effectiveness and safety of GAE with IACI in comparison.
| Study group | Role | What they receive |
|---|---|---|
| GAE with IACI | Experimental | Participants in this arm will undergo geniculate artery embolization (GAE) followed by an intraoperative intra-articular corticosteroid injection (IACI). The procedure aims to alleviate post-procedural pain and improve early functional outcomes in patients with knee osteoarthritis (OA). Receives: Procedure: Geniculate Artery Embolization with Intra-articular Corticosteroid Injection (GAE with IACI) |
| GAE alone | Active comparator | Participants in this arm will undergo geniculate artery embolization (GAE) without the additional intraoperative intra-articular corticosteroid injection. This group will serve as the control to evaluate the effectiveness and safety of GAE with IACI in comparison. Receives: Procedure: Geniculate Artery Embolization alone (GAE alone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity
Pain intensity will be measured using the Visual Analog Scale (VAS) at baseline, 1 week, 2 weeks, and 4 weeks post-procedure.
Measured: 1 week, 2 weeks, and 4 weeks post-procedure
Secondary outcomes (4)
Functional Improvement (KOOS)
Functional improvement will be assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS) at 1 week, 2 weeks, and 4 weeks post-procedure.
Measured: 1 week, 2 weeks, and 4 weeks post-procedure
Functional Improvement (WOMAC)
Functional improvement will be assessed using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) at 1 week, 2 weeks, and 4 weeks post-procedure.
Measured: 1 week, 2 weeks, and 4 weeks post-procedure
Incidence of Procedure-Related Adverse Events
Monitoring and recording any adverse events related to the genicular nerve ablation procedures
Measured: Throughout the study period
Patient Satisfaction with the Procedure
Measured using a structured patient satisfaction questionnaire (PSQ) to gauge participants' satisfaction with the pain relief and overall experience of the procedure.
Measured: 4 weeks post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start29 Sep 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- 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
- Model description
- Participants will be randomized into two groups: Group A receiving geniculate artery embolization (GAE) with intra-articular corticosteroid injection (IACI) and Group B receiving GAE alone.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ahmed Awad Bessar, Zagazig University
- Investigators
- Ahmed A Bessar, MD, PhD, Principal investigator, Assistant Professor of Diagnostic and Interventional Radiology, Zagazig Uni.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514716
- Sponsor's protocol ID
- GAEIACI-OA
- Status last verified
- Sep 2024
- First submitted
- 17 Jul 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this time, there is no plan to share individual participant data (IPD) with other researchers. This decision is based on considerations related to patient confidentiality, data privacy concerns, and the absence of a current infrastructure for secure data sharing. The primary results of the study will be published in peer-reviewed journals and presented at scientific conferences, ensuring that the findings are accessible to the broader research community.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Intra-articular Corticosteroid Injection in Geniculate Artery Embolization for Knee Osteoarthritis: A Comparative Study
- ClinicalTrials.gov ID
- NCT06514716
- Acronym / sponsor ID
- GAEIACI-OA
- Conditions
- Knee Osteoarthritis, Pain, Musculoskeletal
- Keywords
- Geniculate Artery Embolization, Intra-articular Corticosteroid Injection, Pain Relief, Functional Improvement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 29 Sep 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 23 Jul 2024 (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.
The goal of this clinical trial is to investigate the effectiveness and safety of intra-articular corticosteroid injection (IACI) in alleviating post-procedural pain and improving early outcomes in patients undergoing geniculate artery embolization (GAE) for knee osteoarthritis (OA). The main questions it aims to answer are:
- Does intra-articular corticosteroid injection reduce pain levels post-procedure compared to GAE alone?
- Does the combination of GAE and IACI improve functional outcomes and patient-reported outcomes compared to GAE alone?
Investigators will compare patients receiving GAE with IACI to those receiving GAE alone to see if the addition of IACI provides superior pain relief and functional improvement.
Participants will:
- Undergo geniculate artery embolization, with or without intra-articular corticosteroid injection.
- Have their pain levels assessed using the Visual Analog Scale (VAS) at 1 week, 2 weeks, and 4 weeks post-procedure.
- Complete functional outcome assessments using the KOOS and WOMAC scores.
- Report any adverse events throughout the study period.
Detailed description
This study is a prospective, randomized, comparative trial designed to evaluate the role of intra-articular corticosteroid injection (IACI) in patients undergoing geniculate artery embolization (GAE) for knee osteoarthritis (OA). The trial will enroll adult participants diagnosed with knee OA who are eligible for GAE.
Participants will be randomized into two groups: Group A (GAE with IACI) and Group B (GAE alone). The primary outcome measure will be the Visual Analog Scale (VAS) pain scores at 1 week, 2 weeks, and 4 weeks post-procedure. Secondary outcome measures will include functional improvement assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS) and the Western Ontario and McMaster Universities Arthritis Index (WOMAC), patient-reported outcomes, and the incidence of adverse events.
The study aims to determine whether the addition of IACI to GAE provides better pain relief and functional outcomes compared to GAE alone. Data will be collected at baseline and specified time points post-procedure, and statistical analysis will be conducted to compare the outcomes between the two groups. This study is conducted in accordance with the principles of the Declaration of Helsinki and has received ethical approval from the institutional review board. Informed consent will be obtained from all participants before enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized into two groups: Group A receiving geniculate artery embolization (GAE) with intra-articular corticosteroid injection (IACI) and Group B receiving GAE alone.
| Arm | Type | Receives |
|---|---|---|
| GAE with IACI | Experimental | Procedure: Geniculate Artery Embolization with Intra-articular Corticosteroid Injection (GAE with IACI)Participants in this arm will undergo geniculate artery embolization (GAE) followed by an intraoperative intra-articular corticosteroid injection (IACI). The procedure aims to alleviate post-procedural pain and improve early functional outcomes in patients with knee osteoarthritis (OA). |
| GAE alone | Active comparator | Procedure: Geniculate Artery Embolization alone (GAE alone)Participants in this arm will undergo geniculate artery embolization (GAE) without the additional intraoperative intra-articular corticosteroid injection. This group will serve as the control to evaluate the effectiveness and safety of GAE with IACI in comparison. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years and older
- Diagnosed with knee osteoarthritis (OA) based on clinical and radiographic criteria.
- Eligible for geniculate artery embolization (GAE) as determined by the treating physician.
- Able to provide informed consent and comply with the study protocol.
Key exclusion criteria (7 listed)
- Contraindications to corticosteroid injections or geniculate artery embolization.
- Pregnant or breastfeeding women.
- Active infection or skin condition at the injection site.
- Severe cardiovascular, renal, or hepatic diseases that may affect study participation.
- Previous knee surgery within the last 6 months.
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 |
|---|---|---|
| Geniculate Artery Embolization with Intra-articular Corticosteroid Injection (GAE with IACI)Participants will undergo geniculate artery embolization (GAE) followed by an intraoperative intra-articular corticosteroid injection (IACI). This combination aims to alleviate post-procedural pain and improve early functional outcomes in patients with knee osteoarthritis (OA). | Procedure or surgery | GAE with IACI |
| Geniculate Artery Embolization alone (GAE alone)Participants will undergo geniculate artery embolization (GAE) without the additional intraoperative intra-articular corticosteroid injection. This procedure aims to serve as a control to evaluate the effectiveness and safety of GAE with IACI in comparison. | Procedure or surgery | GAE alone |
Primary outcome
Change in Pain Intensity
Time frame: 1 week, 2 weeks, and 4 weeks post-procedure
Pain intensity will be measured using the Visual Analog Scale (VAS) at baseline, 1 week, 2 weeks, and 4 weeks post-procedure.
4 secondary outcomes
Functional Improvement (KOOS)
Time frame: 1 week, 2 weeks, and 4 weeks post-procedure
Functional Improvement (WOMAC)
Time frame: 1 week, 2 weeks, and 4 weeks post-procedure
Incidence of Procedure-Related Adverse Events
Time frame: Throughout the study period
Patient Satisfaction with the Procedure
Time frame: 4 weeks post-procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: No. At this time, there is no plan to share individual participant data (IPD) with other researchers. This decision is based on considerations related to patient confidentiality, data privacy concerns, and the absence of a current infrastructure for secure data sharing. The primary results of the study will be published in peer-reviewed journals and presented at scientific conferences, ensuring that the findings are accessible to the broader research community.
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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.
Ahmed A Bessar, MD, PhD principal investigator
Assistant Professor of Diagnostic and Interventional Radiology, Zagazig Uni.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Geniculate Artery Embolization with Intra-articular Corticosteroid Injection (GAE with IACI) and Geniculate Artery Embolization alone (GAE alone) in people with Knee Osteoarthritis and Pain, Musculoskeletal, run by Zagazig University at 1 site in Egypt.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 1 Oct 2024. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed A Bessar, MD, PhD (+201000089595, Ahmedawadbessar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity (time frame: 1 week, 2 weeks, and 4 weeks post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2024.