Osteoarthritis (OA) of the KneeGET-INNCT06929585
Genicular Artery Embolization (GAE) vs inTra-articular Corticosteroid Injection for Osteoarthritic Knee Pain.
A study testing Genicular artery embolization and Intra-articular injection with corticosteroids. in people with Osteoarthritis (OA) of the Knee, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This study investigates genicular artery embolization (GAE) as a minimally invasive alternative to ntra-articular corticosteroid injections (IA) or treating knee osteoarthritis (OA) pain. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis (OA) of the Knee
- What is being tested?
- Genicular artery embolization and Intra-articular injection with corticosteroids.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Mar 2025to 2 Oct 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 40 years
- Symptomatic knee pain, with numeric rating scale (NRS) ≥ 4.
- Insufficient or resistant to conservative treatment, including oral analgesics, physical therapy, intra-articular injections for at least 3 months, before the enrollment.
- Weight bearing X ray of knee: osteoarthritis of Kellgren-Lawrence grade 1, 2, or 3.
Who cannot join
- History of trauma in recent 6 months.
- Bleeding tendency.
- Poor renal function (serum creatinine > 2.0 mg/dL).
- Pregnancy or breast-feeding.
- Severe peripheral arterial occlusive disease (PAOD).
- Local infections or inflammatory arthritis of knee.
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- Rheumatoid arthritis or other rheumatological diseases.
- Prior knee surgeries (arthroscopic surgery, menisci repair, cruciate ligament reconstruction, arthroplasty of knee) due to knee pain.
- Malignancy
- ECOG > grade 2
- Life expectancy less than 2 years.
- Any other condition related to the patient's health, regarded exclusionary in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hosiptal Yunlin Branch
Douliu, Yunlin, 640
About this study
Official title: Genicular Artery Embolization (GAE) vs inTra-articular Corticosteroid Injection for Osteoarthritic Knee Pain. (GET-IN Study)
This study investigates genicular artery embolization (GAE) as a minimally invasive alternative to ntra-articular corticosteroid injections (IA) or treating knee osteoarthritis (OA) pain. Designed as a randomized controlled tria, the study compares pain relief effectiveness and safety between GAE and IA over a 12-month follow-up. Eligible participants are aged over 40 with symptomatic knee OA resistant to conservative treatment. Primary outcomes focus on pain reduction (NRS score), while secondary measures include function, quality of life, imaging findings, and adverse events.
- Conditions
- Osteoarthritis (OA) of the Knee
- Being tested
- Genicular artery embolization, Intra-articular injection with corticosteroids.
- Keywords
- knee osteoarthritis, genicular artery embolization, imipenem/cilastatin, intra-articular corticosteroid injection
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genicular artery embolizationProcedure or surgery
The patient will receive GAE procedure and sham IA procedure.
Intra-articular injection with corticosteroids.Procedure or surgery
The patient will receive IA procedure and sham GAE procedure.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm: GAE (IPM/CS). | Experimental | Genicular artery embolization with imipenem/cilastatin (IPM/CS). Receives: Procedure: Genicular artery embolization |
| Comparator: IA (corticosteroids) | Active comparator | The patient will receive IA procedure and sham GAE procedure. Receives: Procedure: Intra-articular injection with corticosteroids. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Endpoint: numeric rating scale (NRS)
Changes of pain score (NRS) at the 3-month compared with the baseline.
Measured: Post-intervention 3 month.
Secondary outcomes (6)
Clinical Efficacy: numeric rating scale (NRS)
Maximum decreased of pain score (NRS)
Measured: In the one-year period after intervention.
Clinical Efficacy: WOMAC
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
*Clinical success defined as ≥ 40% improvement of the WOMAC score.
Measured: Pre-intervention, post-1, 3, 6, 12 months
Clinical Efficacy: Lequesne'Index
Lequesne index for knee osteoarthritis severity.
Measured: Pre-intervention, post-1, 3, 6, 12 months
Clinical Outcome: PGIC
Self-report measure Patient Global Impression of Change (PGIC).
Measured: Pre-intervention, post-1, 3, 6, 12 months
Clinical Outcome: Analgesic Usage and other Pain Control Treatments
Use of narcotics or non-steroidal anti-inflammatory drugs (NSAID's); other pain control treatments.
Measured: Pre-intervention, post-1, 3, 6, 12 months
Clinical Outcome: Quality of Life
EQ-5D-5L questionnaire
Measured: Pre-intervention, post-1, 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start25 Mar 2025
- Primary completion2 Oct 2025
- Study completion2 Oct 2025
Why it stopped: The trial was terminated due to infeasible enrollment. Only one participant was enrolled, and the comparator arm was not initiated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis (OA) of the KneeStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital, Yun-Lin Branch
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06929585
- Sponsor's protocol ID
- 202408153RIND
- Acronym
- GET-IN
- Status last verified
- Nov 2025
- First submitted
- 8 Apr 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genicular Artery Embolization (GAE) vs inTra-articular Corticosteroid Injection for Osteoarthritic Knee Pain. (GET-IN Study)
- ClinicalTrials.gov ID
- NCT06929585
- Acronym / sponsor ID
- GET-IN / 202408153RIND
- Conditions
- Osteoarthritis (OA) of the Knee
- Keywords
- knee osteoarthritis, genicular artery embolization, imipenem/cilastatin, intra-articular corticosteroid injection
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial was terminated due to infeasible enrollment. Only one participant was enrolled, and the comparator arm was not initiated.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital, Yun-Lin Branch
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 2 Oct 2025 (actual)
- Study completion
- 2 Oct 2025 (actual)
- First posted
- 16 Apr 2025 (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.
This study investigates genicular artery embolization (GAE) as a minimally invasive alternative to ntra-articular corticosteroid injections (IA) or treating knee osteoarthritis (OA) pain. Designed as a randomized controlled tria, the study compares pain relief effectiveness and safety between GAE and IA over a 12-month follow-up. Eligible participants are aged over 40 with symptomatic knee OA resistant to conservative treatment. Primary outcomes focus on pain reduction (NRS score), while secondary measures include function, quality of life, imaging findings, and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm: GAE (IPM/CS). | Experimental | Procedure: Genicular artery embolizationGenicular artery embolization with imipenem/cilastatin (IPM/CS). |
| Comparator: IA (corticosteroids) | Active comparator | Procedure: Intra-articular injection with corticosteroids.The patient will receive IA procedure and sham GAE procedure. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 40 years
- Symptomatic knee pain, with numeric rating scale (NRS) ≥ 4.
- Insufficient or resistant to conservative treatment, including oral analgesics, physical therapy, intra-articular injections for at least 3 months, before the enrollment.
- Weight bearing X ray of knee: osteoarthritis of Kellgren-Lawrence grade 1, 2, or 3.
Key exclusion criteria (12 listed)
- History of trauma in recent 6 months.
- Bleeding tendency.
- Poor renal function (serum creatinine > 2.0 mg/dL).
- Pregnancy or breast-feeding.
- Severe peripheral arterial occlusive disease (PAOD).
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 |
|---|---|---|
| Genicular artery embolizationThe patient will receive GAE procedure and sham IA procedure. | Procedure or surgery | Experimental arm: GAE (IPM/CS). |
| Intra-articular injection with corticosteroids.The patient will receive IA procedure and sham GAE procedure. | Procedure or surgery | Comparator: IA (corticosteroids) |
Primary outcome
Primary Efficacy Endpoint: numeric rating scale (NRS)
Time frame: Post-intervention 3 month.
Changes of pain score (NRS) at the 3-month compared with the baseline.
6 secondary outcomes
Clinical Efficacy: numeric rating scale (NRS)
Time frame: In the one-year period after intervention.
Clinical Efficacy: WOMAC
Time frame: Pre-intervention, post-1, 3, 6, 12 months
Clinical Efficacy: Lequesne'Index
Time frame: Pre-intervention, post-1, 3, 6, 12 months
Clinical Outcome: PGIC
Time frame: Pre-intervention, post-1, 3, 6, 12 months
Clinical Outcome: Analgesic Usage and other Pain Control Treatments
Time frame: Pre-intervention, post-1, 3, 6, 12 months
Clinical Outcome: Quality of Life
Time frame: Pre-intervention, post-1, 3, 6, 12 months
Results and safety
The study was stopped early (reason given: The trial was terminated due to infeasible enrollment. Only one participant was enrolled, and the comparator arm was not initiated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No
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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 Genicular artery embolization and Intra-articular injection with corticosteroids. in people with Osteoarthritis (OA) of the Knee, run by National Taiwan University Hospital at 1 site in Taiwan.
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 12 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: stopped early, as of the sponsor's last update on 19 Nov 2025. 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 Taiwan. 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 was stopped early (reason given: The trial was terminated due to infeasible enrollment. Only one participant was enrolled, and the comparator arm was not initiated.). Results are not available in the source record.
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?
Primary Efficacy Endpoint: numeric rating scale (NRS) (time frame: Post-intervention 3 month.). 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 19 Nov 2025.