Geniculate Artery Embolization for Osteoarthritis

NCT04456569 | Recruiting DMC FDA Device

• 1 other identifier: RAD-2019-27368
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The need for exploration of more definitive and cost effective non-arthroplasty treatments of osteoarthritis (OA) has been demonstrated by the orthopedic and health economic research. Embolotherapy of neovessels associated with OA joints has been shown to be promising in patients with knee OA. There is a need for level one evidence drawn from randomized clinical trials to prove the safety, feasibility and efficacy of knee embolotherapy compared to standard of care. This randomized pilot study will assign 10 patients with mild-moderate OA to undergo geniculate artery embolization plus standard of care (defined in this study as: physical therapy and oral anti-inflammatory medications, with a maximum of 1 joint injection at the time of enrollment) and 10 patients to receive only medical standard of care (also having had a maximum of 1 joint injection prior to enrollment). The goal of this pilot study is to obtain preliminary estimates of safety and efficacy of embolotherapy to provide sustained symptom control and modify disease progression in patients with mild to moderate knee OA.

Conditions

Osteo Arthritis Knee; Arthritis; Osteoarthritis; Osteoarthritis, Knee

Keywords

Embolotherapy

Outcome Measures

Primary Outcomes (1)

• Safety as Assessed by Grade 3-4 Adverse events

  Safety will be reported using the combined number of grade 3 and 4 adverse events that occur in each arm.

  12 months

Secondary Outcomes (8)

• Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)

  baseline, 1 month, 6 months, 12 months

• Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  baseline, 1 month, 6 months, 12 months

• IL-6 Concentration

  baseline, 1 month, 12 months

• Prostaglandin E2 Concentration

  baseline, 1 month, 12 months

• Matrix Metalloprotinase 1 Concentration

  baseline, 1 month, 12 months

Other Outcomes (2)

• Feasibility as Assessed by Protocol Adherence

  12 months

• Feasibility as Assessed by Recruitment Rate

  12 months

Study Arms (2)

GAE + Standard of Care

EXPERIMENTAL

Participants in this arm will receive geniculate artery embolization and standard of care.

Device: Geniculate Artery Embolization

Standard of Care

NO INTERVENTION

Participants in this arm will receive standard of care only.

Interventions

Geniculate Artery Embolization DEVICE

All patients within the embolization group will undergo unilateral angiography and embolization of the appropriate treatment limb geniculate arteries. For patients with bilateral disease the more clinically symptomatic side will be chosen as the treatment/control knee.

GAE + Standard of Care

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 40 - 70 years of age.
• Unilaterally dominant symptomatic OA (bilateral radiographic OA will not exclude).
• Symptomatically refractory of at least 3 months of medical and/or rehabilitation measures (anti-inflammatory drugs, and/or physical therapy, and/or strength conditioning, and/or intra-articular injections of the affected knee in the last 3 months).
• Kellgren-Lawrence grade 1, 2, or 3 on radiograph of the knee
• Willing to comply with the protocol requirements and willing to undergo non- contrast MRI during screening and at 12 months.
• Willing to comply with regular follow up during the 12 month follow-up period.
• Not a current candidate for partial or total knee arthroplasty.
• WOMAC Score \>=6 in at least 2 categories.

You may not qualify if:

• BMI \>35 kg/m2
• Advanced peripheral arterial disease (resting ABI \<= 0.9).
• Known significant peripheral arterial disease precluding common femoral catheterization
• Have smoked tobacco regularly (smoking 1 or more tobacco product(s) per week) within the last year
• Diabetics with hemoglobin A1C of \>9%
• Previous lower extremity embolization
• Uncontrolled emotional disorders per patient medical history
• Chronic pain syndrome or currently under a pain contract.
• Anatomic variants involving the lower extremities which would increase the risk of non-target embolization
• Renal insufficiency based on an estimated GFR\<45 ml/min who are not already on hemodialysis.
• Abnormal INR (\>1.5)
• Platelet count \<50x109/L.
• Currently receiving medications for anticoagulation which cannot safely be held for the procedure and for 7 days post-procedure.
• Known severe allergy to iodine which cannot be adequately pre-medicated
• Pregnant or intend to become pregnant within 6 months of the procedure

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Arthritis; Osteoarthritis; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Reza Talaie, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Coordinator

CONTACT

612-624-7463; SurgCTO@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 2, 2020
• Study Start: February 1, 2022
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

US (1)