Knee OsteoarthritisPhase 2SHAM-PAINNCT06859164
Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis
A Phase 2 study testing Genicular Artery Embolization, Lipiodol and Simple angiogram in people with Knee Osteoarthritis and Knee Osteoarthritis (Knee OA), run by University of Utah at 1 site in United States.
Trial summary
Genicular Artery Embolization for Reducing Pain in Symptomatic Knee Osteoarthritis: A Pilot Randomized Sham-Controlled Study (SHAM-PAIN) is a NIH-NIAMS funded project designed to assess enrollment feasibility and detect any differences between GAE and a similar sham intervention in reducing KOA-related pain at 3… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Knee Osteoarthritis, Knee Osteoarthritis (Knee OA), Knee Osteoarthritis (OA)
- What is being tested?
- Genicular Artery Embolization, Lipiodol and Simple angiogram
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to 31 Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 40-80
- Bilateral or unilateral knee pain attributed to osteoarthritis (treat the knee with greater pain-if equal, patient chooses)
- Grade 2-4 osteoarthritis on standing weight-bearing knee radiographs per the Kellgren-Lawrence grading scale
- Knee pain > 6 months, refractory to conservative non-operative management, and scored ≥ 4 on Visual Analog Scale (VAS) (e.g., rest, activity modification, weight control, bracing, supervised physical therapy, nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, oral opiates, intra-articular hyaluronic acid, PRP, stem cells, and/or oral/injectable corticosteroids)
- Refusal of intra-articular corticosteroid injection
Who cannot join
- Active malignancy
- Active infection of the affected knee
- Corticosteroid injection of the affected knee within 3 months of enrollment
- Rheumatoid arthritis or other seronegative arthropathy
- Previous surgery of the affected knee (e.g., meniscus repair, meniscectomy, anterior cruciate ligament (ACL)/posterior cruciate ligament (PCL) reconstruction, chondroplasty, microfracture, loose-body removal, synovectomy, lateral release, patellar/quadriceps tendon repair, total or partial knee replacement, osteotomy, cartilage transplant), except diagnostic arthroscopy
- Grade 0-1 osteoarthritis per Kellgren-Lawrence grading scale of the affected knee
Show all 24Show fewer
- Pregnancy or expected pregnancy
- GFR < 60 mL/min/1.73 m²
- Anaphylactic reaction to iodinated contrast
- Moderate to severe pain in other ipsilateral lower-limb joints (ankle, hip) with VAS > 4
- Body weight > 400 lbs (unsafe for angiography)
- Peripheral arterial disease of the treated extremity (Rutherford Grade 2 or greater)
- Type 1 diabetes mellitus
- Long-acting corticosteroid use within 6 months (3 months for short-acting)
- History or other evidence of acute kidney injury (AKI)
- History of reaction to contrast media, bronchial asthma, or allergic disorders
- History of hypersensitivity to gadolinium-based contrast agents (GBCAs)
- Chronic widespread generalized pain >4 on VAS pain scale, including neuropathic pain
- Major depressive disorder within 2 years before screening
- Other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder)
- Suicide attempt or suicidal behavior within 30 days before screening
- Diagnosis of fibromyalgia
- Considering total knee replacement in the next year
- Any other condition, unwillingness, or inability that, in the investigator's opinion, could jeopardize the subject's safety or protocol compliance
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Layth Alkhani, BS contact
United States1 site, 1 recruiting
- Recruiting
University of Utah
Salt Lake City, Utah, 84112
Osman Ahmed, MD, 8478124513, osman.ahmed@utah.edu
Layth Alkhani, BS, layth.alkhani@utah.edu
About this study
Official title: Genicular Artery Embolization for Reducing Pain in Symptomatic Knee Osteoarthritis: A Pilot Randomized Sham-Controlled Study
Genicular Artery Embolization for Reducing Pain in Symptomatic Knee Osteoarthritis: A Pilot Randomized Sham-Controlled Study (SHAM-PAIN) is a NIH-NIAMS funded project designed to assess enrollment feasibility and detect any differences between GAE and a similar sham intervention in reducing KOA-related pain at 3 months as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscore. Additionally, this study aims to determine the magnitude of difference in pain response between GAE and sham to adequately power a larger, more definitive randomized sham-controlled trial (RCT). The influence of psychosocial and psychocognitive factors, changes in analgesic use, and conditions of knee joint cartilage and effusion will similarly be explored to determine their impacts on perceived pain response to GAE.
- Being tested
- Genicular Artery Embolization, Lipiodol, Simple angiogram
- Keywords
- Osteoarthritis, Knee pain, MSK pain, Musculoskeletal Pain, Osteoarthritis of the knee, GAE, Genicular artery embolization, Geniculate artery embolization, MSK embolization, Musculoskeletal Embolization, Embolization, Musculoskeletal, Temporary Embolization
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genicular Artery EmbolizationProcedure or surgery
Also called GAE, Geniculate Artery Embolization
Embolization of genicular arteries that demonstrate neoangiogenesis or blush on angiogram.
LipiodolDevice
3:1 emulsion of Lipiodol to Optiray
Simple angiogramProcedure or surgery
Simple angiogram of the genicular arteries
| Study group | Role | What they receive |
|---|---|---|
| GAE Arm | Experimental | In this study, GAE is performed using the Lipiojoint technique described by Sapoval et al. This method utilizes a 3:1 emulsion of Lipiodol® (a transient embolic agent that penetrates distally to about 30 microns) and Optiray® to target the genicular arteries supplying areas of synovial hypervascularity and neo-angiogenesis. The embolic effect is temporary-lasting roughly 10 minutes-after which angiographic imaging shows resolution of the embolization with no damage to the surrounding skin, tendon, or bone. The endpoint of the procedure is to achieve complete stasis in the targeted vessels. 20 participants will be randomly allocated to this arm. Receives: Procedure: Genicular Artery Embolization; Device: Lipiodol; Procedure: Simple angiogram |
| Sham Arm | Sham comparator | Participants assigned to the sham group undergo a similar preparatory process, including angiography and catheterization of all genicular arteries. However, no embolic agent is administered. Instead, after performing selective angiograms, these participants do not receive any embolization. 20 participants will be randomly allocated to this arm. Receives: Procedure: Simple angiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in KOOS pain subscore
Percent change in KOOS pain subscale score, scaled to a range of 0-100, from baseline to 3 months post-randomization of both GAE and sham groups.
Measured: 3 months
Secondary outcomes (9)
WOMAC knee pain and dysfunction
Reduction in knee pain and dysfunction (WOMAC) at 1, 3, 6, 9, and 12 months.
Measured: 1, 3, 6, 9, and 12 months.
KOOS pain and dysfunction
Absolute reduction in knee pain and dysfunction (KOOS) at 1, 3, 6, 9, and 12 months
Measured: 1, 3, 6, 9, and 12 months
VAS Score
Visual Analog Score (VAS) for pain at 0, 1, 6, 9, and 12 months post treatment
Measured: 0, 1, 6, 9, and 12 months
Crossover
Rate of cross-over from sham to GAE at 3 months
Measured: 3 months
Analgesic Reduction
Usage of opiate/analgesic medications at baseline, 1, 3, 6, 9, and 12 months post intervention
Measured: Baseline, 1, 3, 6, 9, and 12 months post intervention
Whole Knee Synovitis Scoring
Contrast Enhanced MRI with Whole Knee Synovitis Scoring at baseline and 3 months
Measured: Baseline and 3 months
Perfusion
Perfusion quantification using pre and post embolization using CT-Perfusion scanning
Measured: Procedure
Knee replacement
Rate of total knee replacement at 3 months
Measured: 3 months
Corticosteroid injection usage
Corticosteroid injection rate usage at baseline, 1, 3, 6, 9, and 12 months post intervention
Measured: Baseline, 1, 3, 6, 9, and 12 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start1 Jul 2026
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Osman Ahmed, University of Utah
- Investigators
- Osman Ahmed, MD, Principal investigator, University of Utah Department of Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06859164
- Sponsor's protocol ID
- IRB24-1674
- Other IDs
- 1R21AR082123-01A1
- Acronym
- SHAM-PAIN
- Status last verified
- Jun 2026
- First submitted
- 23 Feb 2025
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Will need to be considered on an individual basis given the desire to protect PHI
Publications
Ahmed O, Block J, Mautner K, Plancher K, Anitescu M, Isaacson A, Filippiadis DK, Epelboym Y, Bercu Z, Mitchell JW, Cristescu M, White SB, Prologo JD. Percutaneous Management of Osteoarthritis in the Knee: Proceedings from the Society of Interventional Radiology Research Consensus Panel. J Vasc Interv Radiol. 2021 Jun;32(6):919.e1-919.e6. doi: 10.1016/j.jvir.2021.03.409. Epub 2021 Mar 6. No abstract available.
PubMed 33689834Ahmed O, Epelboym Y, Haskal ZJ, Okuno Y, Taslakian B, Sapoval M, Nikolic B, Golzarian J, Gaba RC, Little M, Isaacson A, Padia SA, Sze DY. Society of Interventional Radiology Research Reporting Standards for Genicular Artery Embolization. J Vasc Interv Radiol. 2024 Aug;35(8):1097-1103. doi: 10.1016/j.jvir.2024.04.018. Epub 2024 Apr 27.
PubMed 38685470Dariushnia SR, Redstone EA, Heran MKS, Cramer HR Jr, Ganguli S, Gomes AS, Hogan MJ, Himes EA, Patel S, Schiro BJ, Lewis CA. Society of Interventional Radiology Quality Improvement Standards for Percutaneous Transcatheter Embolization. J Vasc Interv Radiol. 2021 Mar;32(3):476.e1-476.e33. doi: 10.1016/j.jvir.2020.10.022. No abstract available.
PubMed 33640083Parry E, Ogollah R, Peat G. Significant pain variability in persons with, or at high risk of, knee osteoarthritis: preliminary investigation based on secondary analysis of cohort data. BMC Musculoskelet Disord. 2017 Feb 14;18(1):80. doi: 10.1186/s12891-017-1434-3.
PubMed 28196504Derkach M, Al Sayah F, Ohinmaa A, Svenson LW, Johnson JA. Comparative performance of the EuroQol EQ-5D-5L and the CDC healthy days measures in assessing population health. J Patient Rep Outcomes. 2022 Jun 13;6(1):64. doi: 10.1186/s41687-022-00474-7.
PubMed 35696002Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999 Apr;79(4):371-83.
PubMed 10201543Salaffi F, Leardini G, Canesi B, Mannoni A, Fioravanti A, Caporali R, Lapadula G, Punzi L; GOnorthrosis and Quality Of Life Assessment (GOQOLA). Reliability and validity of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index in Italian patients with osteoarthritis of the knee. Osteoarthritis Cartilage. 2003 Aug;11(8):551-60. doi: 10.1016/s1063-4584(03)00089-x.
PubMed 12880577Little MW, O'Grady A, Briggs J, Gibson M, Speirs A, Al-Rekabi A, Yoong P, Ariyanayagam T, Davies N, Tayton E, Tavares S, MacGill S, McLaren C, Harrison R. Genicular Artery embolisation in Patients with Osteoarthritis of the Knee (GENESIS) Using Permanent Microspheres: Long-Term Results. Cardiovasc Intervent Radiol. 2024 Dec;47(12):1750-1762. doi: 10.1007/s00270-024-03752-7. Epub 2024 May 31.
PubMed 38819473Padia SA, Genshaft S, Blumstein G, Plotnik A, Kim GHJ, Gilbert SJ, Lauko K, Stavrakis AI. Genicular Artery Embolization for the Treatment of Symptomatic Knee Osteoarthritis. JB JS Open Access. 2021 Oct 21;6(4):e21.00085. doi: 10.2106/JBJS.OA.21.00085. eCollection 2021 Oct-Dec.
PubMed 34703964Sapoval M, Querub C, Pereira H, Pellerin O, Boeken T, Di Gaeta A, Ahmar MA, Lefevre-Colau MM, Nguyen C, Daste C, Lacroix M, Laredo JD, Sabatier B, Martelli N, Chatellier G, Dean C, Rannou F. Genicular artery embolization for knee osteoarthritis: Results of the LipioJoint-1 trial. Diagn Interv Imaging. 2024 Apr;105(4):144-150. doi: 10.1016/j.diii.2023.12.003. Epub 2023 Dec 14.
PubMed 38102013Lim WB, Al-Dadah O. Conservative treatment of knee osteoarthritis: A review of the literature. World J Orthop. 2022 Mar 18;13(3):212-229. doi: 10.5312/wjo.v13.i3.212. eCollection 2022 Mar 18.
PubMed 35317254Heidari B. Knee osteoarthritis prevalence, risk factors, pathogenesis and features: Part I. Caspian J Intern Med. 2011 Spring;2(2):205-12.
PubMed 24024017GBD 2021 Osteoarthritis Collaborators. Global, regional, and national burden of osteoarthritis, 1990-2020 and projections to 2050: a systematic analysis for the Global Burden of Disease Study 2021. Lancet Rheumatol. 2023 Aug 21;5(9):e508-e522. doi: 10.1016/S2665-9913(23)00163-7. eCollection 2023 Sep.
PubMed 37675071
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genicular Artery Embolization for Reducing Pain in Symptomatic Knee Osteoarthritis: A Pilot Randomized Sham-Controlled Study
- ClinicalTrials.gov ID
- NCT06859164
- Acronym / sponsor ID
- SHAM-PAIN / IRB24-1674
- Keywords
- Osteoarthritis, Knee pain, MSK pain, Musculoskeletal Pain, Osteoarthritis of the knee, GAE, Genicular artery embolization, Geniculate artery embolization
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 5 Mar 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.
Genicular Artery Embolization for Reducing Pain in Symptomatic Knee Osteoarthritis: A Pilot Randomized Sham-Controlled Study (SHAM-PAIN) is a NIH-NIAMS funded project designed to assess enrollment feasibility and detect any differences between GAE and a similar sham intervention in reducing KOA-related pain at 3 months as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscore. Additionally, this study aims to determine the magnitude of difference in pain response between GAE and sham to adequately power a larger, more definitive randomized sham-controlled trial (RCT). The influence of psychosocial and psychocognitive factors, changes in analgesic use, and conditions of knee joint cartilage and effusion will similarly be explored to determine their impacts on perceived pain response to GAE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GAE Arm | Experimental | Procedure: Genicular Artery Embolization, Device: Lipiodol, Procedure: Simple angiogramIn this study, GAE is performed using the Lipiojoint technique described by Sapoval et al. This method utilizes a 3:1 emulsion of Lipiodol® (a transient embolic agent that penetrates distally to about 30 microns) and Optiray® to target the genicular arteries supplying areas of synovial hypervascularity and neo-angiogenesis. The embolic effect is temporary-lasting roughly 10 minutes-after which angiographic imaging shows resolution of the embolization with no damage to the surrounding skin, tendon, or bone. The endpoint of the procedure is to achieve complete stasis in the targeted vessels. 20 participants will be randomly allocated to this arm. |
| Sham Arm | Sham comparator | Procedure: Simple angiogramParticipants assigned to the sham group undergo a similar preparatory process, including angiography and catheterization of all genicular arteries. However, no embolic agent is administered. Instead, after performing selective angiograms, these participants do not receive any embolization. 20 participants will be randomly allocated to this arm. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 40-80
- Bilateral or unilateral knee pain attributed to osteoarthritis (treat the knee with greater pain-if equal, patient chooses)
- Grade 2-4 osteoarthritis on standing weight-bearing knee radiographs per the Kellgren-Lawrence grading scale
- Knee pain > 6 months, refractory to conservative non-operative management, and scored ≥ 4 on Visual Analog Scale (VAS) (e.g., rest, activity modification, weight control, bracing, supervised physical therapy, nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, oral opiates, intra-articular hyaluronic acid, PRP, stem cells, and/or oral/injectable corticosteroids)
- Refusal of intra-articular corticosteroid injection
Key exclusion criteria (24 listed)
- Active malignancy
- Active infection of the affected knee
- Corticosteroid injection of the affected knee within 3 months of enrollment
- Rheumatoid arthritis or other seronegative arthropathy
- Previous surgery of the affected knee (e.g., meniscus repair, meniscectomy, anterior cruciate ligament (ACL)/posterior cruciate ligament (PCL) reconstruction, chondroplasty, microfracture, loose-body removal, synovectomy, lateral release, patellar/quadriceps tendon repair, total or partial knee replacement, osteotomy, cartilage transplant), except diagnostic arthroscopy
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 EmbolizationAlso: GAE, Geniculate Artery EmbolizationEmbolization of genicular arteries that demonstrate neoangiogenesis or blush on angiogram. | Procedure or surgery | GAE Arm |
| Lipiodol3:1 emulsion of Lipiodol to Optiray | Device | GAE Arm |
| Simple angiogramSimple angiogram of the genicular arteries | Procedure or surgery | GAE Arm, Sham Arm |
Primary outcome
Reduction in KOOS pain subscore
Time frame: 3 months
Percent change in KOOS pain subscale score, scaled to a range of 0-100, from baseline to 3 months post-randomization of both GAE and sham groups.
9 secondary outcomes
WOMAC knee pain and dysfunction
Time frame: 1, 3, 6, 9, and 12 months.
KOOS pain and dysfunction
Time frame: 1, 3, 6, 9, and 12 months
VAS Score
Time frame: 0, 1, 6, 9, and 12 months
Crossover
Time frame: 3 months
Analgesic Reduction
Time frame: Baseline, 1, 3, 6, 9, and 12 months post intervention
Whole Knee Synovitis Scoring
Time frame: Baseline and 3 months
Perfusion
Time frame: Procedure
Knee replacement
Time frame: 3 months
Corticosteroid injection usage
Time frame: Baseline, 1, 3, 6, 9, and 12 months post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Background: PubMed 33689834Ahmed O, Block J, Mautner K, Plancher K, Anitescu M, Isaacson A, Filippiadis DK, Epelboym Y, Bercu Z, Mitchell JW, Cristescu M, White SB, Prologo JD. Percutaneous Management of Osteoarthritis in the Knee: Proceedings from the Society of Interventional Radiology Research Consensus Panel. J Vasc Interv Radiol. 2021 Jun;32(6):919.e1-919.e6. doi: 10.1016/j.jvir.2021.03.409. Epub 2021 Mar 6. No abstract available.
- Background: PubMed 38685470Ahmed O, Epelboym Y, Haskal ZJ, Okuno Y, Taslakian B, Sapoval M, Nikolic B, Golzarian J, Gaba RC, Little M, Isaacson A, Padia SA, Sze DY. Society of Interventional Radiology Research Reporting Standards for Genicular Artery Embolization. J Vasc Interv Radiol. 2024 Aug;35(8):1097-1103. doi: 10.1016/j.jvir.2024.04.018. Epub 2024 Apr 27.
- Background: PubMed 33640083Dariushnia SR, Redstone EA, Heran MKS, Cramer HR Jr, Ganguli S, Gomes AS, Hogan MJ, Himes EA, Patel S, Schiro BJ, Lewis CA. Society of Interventional Radiology Quality Improvement Standards for Percutaneous Transcatheter Embolization. J Vasc Interv Radiol. 2021 Mar;32(3):476.e1-476.e33. doi: 10.1016/j.jvir.2020.10.022. No abstract available.
- Background: PubMed 28196504Parry E, Ogollah R, Peat G. Significant pain variability in persons with, or at high risk of, knee osteoarthritis: preliminary investigation based on secondary analysis of cohort data. BMC Musculoskelet Disord. 2017 Feb 14;18(1):80. doi: 10.1186/s12891-017-1434-3.
- Background: PubMed 35696002Derkach M, Al Sayah F, Ohinmaa A, Svenson LW, Johnson JA. Comparative performance of the EuroQol EQ-5D-5L and the CDC healthy days measures in assessing population health. J Patient Rep Outcomes. 2022 Jun 13;6(1):64. doi: 10.1186/s41687-022-00474-7.
- Background: PubMed 10201543Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999 Apr;79(4):371-83.
- Background: PubMed 12880577Salaffi F, Leardini G, Canesi B, Mannoni A, Fioravanti A, Caporali R, Lapadula G, Punzi L; GOnorthrosis and Quality Of Life Assessment (GOQOLA). Reliability and validity of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index in Italian patients with osteoarthritis of the knee. Osteoarthritis Cartilage. 2003 Aug;11(8):551-60. doi: 10.1016/s1063-4584(03)00089-x.
- Background: PubMed 38819473Little MW, O'Grady A, Briggs J, Gibson M, Speirs A, Al-Rekabi A, Yoong P, Ariyanayagam T, Davies N, Tayton E, Tavares S, MacGill S, McLaren C, Harrison R. Genicular Artery embolisation in Patients with Osteoarthritis of the Knee (GENESIS) Using Permanent Microspheres: Long-Term Results. Cardiovasc Intervent Radiol. 2024 Dec;47(12):1750-1762. doi: 10.1007/s00270-024-03752-7. Epub 2024 May 31.
- Background: PubMed 34703964Padia SA, Genshaft S, Blumstein G, Plotnik A, Kim GHJ, Gilbert SJ, Lauko K, Stavrakis AI. Genicular Artery Embolization for the Treatment of Symptomatic Knee Osteoarthritis. JB JS Open Access. 2021 Oct 21;6(4):e21.00085. doi: 10.2106/JBJS.OA.21.00085. eCollection 2021 Oct-Dec.
- Background: PubMed 38102013Sapoval M, Querub C, Pereira H, Pellerin O, Boeken T, Di Gaeta A, Ahmar MA, Lefevre-Colau MM, Nguyen C, Daste C, Lacroix M, Laredo JD, Sabatier B, Martelli N, Chatellier G, Dean C, Rannou F. Genicular artery embolization for knee osteoarthritis: Results of the LipioJoint-1 trial. Diagn Interv Imaging. 2024 Apr;105(4):144-150. doi: 10.1016/j.diii.2023.12.003. Epub 2023 Dec 14.
- Background: PubMed 35317254Lim WB, Al-Dadah O. Conservative treatment of knee osteoarthritis: A review of the literature. World J Orthop. 2022 Mar 18;13(3):212-229. doi: 10.5312/wjo.v13.i3.212. eCollection 2022 Mar 18.
- Background: PubMed 24024017Heidari B. Knee osteoarthritis prevalence, risk factors, pathogenesis and features: Part I. Caspian J Intern Med. 2011 Spring;2(2):205-12.
- Individual participant dataSharing planned: Undecided. Will need to be considered on an individual basis given the desire to protect PHI
Related trials for Knee Osteoarthritis
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Active, not recruiting
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Osteo Arthritis Knee, Joint Diseases
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Recruiting
The Effect of Different Exercise Training Programs on Muscle Oxygenation in Individuals With Knee Osteoarthritis
Osteoarthritis of Knee
Not yet recruiting
Comparison of Telerehabilitation and Usual Rehabilitation After Knee or Hip Surgery
Orthopedic Surgery, Rehabilitation
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.
Layth Alkhani, BS contact
Osman Ahmed, MD principal investigator
University of Utah Department of Radiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Genicular Artery Embolization, Lipiodol and Simple angiogram in people with Knee Osteoarthritis and Knee Osteoarthritis (Knee OA), run by University of Utah at 1 site in United States.
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 5 inclusion and 24 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: looking for participants now, as of the sponsor's last update on 30 Oct 2026. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Osman Ahmed, MD (8478124513, osman.ahmed@utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in KOOS pain subscore (time frame: 3 months). 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 NCT06859164, which also lists 13 linked publications.
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 30 Oct 2026.