Radio- KO Radiotherapy for Knee Osteoarthritis Clinical Trial

NCT06887829 | Recruiting FDA Device

• 1 other identifier: 24-006759
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this study is to investigate whether low-dose radiotherapy is an effective treatment to reduce the pain of knee osteoarthritis. A secondary aim is to determine whether patients experience any more measurable side effects than those receiving sham treatments.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (2)

• Change in Area Under the Curve (AUC) of ICOAP Scores

  Change in the Intermittent and Constant Osteoarthritis Pain (ICOAP) outcome scale weekly for six months after intervention analyzed as area under the curve of patients with Kellgren-Lawrence grade 2-3 knee OA.

  Baseline, 6 months

• Analgesic use frequency in treatment vs. sham participants

  Differences in the rate of improvement between the 2 groups with analysis to include time points of 2 months and 4 months after intervention.

  6 months

Study Arms (2)

Low dose radiotherapy

ACTIVE COMPARATOR

Low dose radiation therapy for knee osteoarthritis

Radiation: Low dose radiotherapy

Placebo

SHAM COMPARATOR

No radiation therapy

Other: Sham comparator

Interventions

Low dose radiotherapy RADIATION

Participants will receive low dose radiotherapy (0.5 Gy) 3 times per week, for two weeks delivered via the X-Strahl Orthovoltage device.

Low dose radiotherapy

Sham comparator OTHER

Participants will receive identical treatment 3 times per week, for two weeks delivered via the X-Strahl Orthovoltage device, without radiation.

Placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 50-85 years
• ICOAP pain scale A1 at least moderate intensity or B6 at least moderate intensity
• diagnosed with primary knee OA ICD-10 codes M17.x
• history of morning stiffness in knees that lasts less than 30 minutes
• history of crepitus without a history of warmth, redness or sudden onset of swelling
• physical exam findings of medial or lateral joint line tenderness on palpation that is in the same location as the knee pain for which their primary care provider has ordered an intraarticular steroid injection into the same knee.
• absence of primary knee pain in the pes anserine or hamstring or gastrocnemius tendons
• radiographic Kellgren-Lawrence grade 2-3 on 4-view knee x-rays taken within the last year
• ability to complete surveys in English

You may not qualify if:

• Kellgren-Lawrence grade 1 or 4
• pregnancy or women 54 years and younger with potential for pregnancy (if they or their partner have not had tubal ligation, hysterectomy, or vasectomy)
• history of ipsilateral intraarticular knee surgery
• use of injected corticosteroids within 3 months or hyaluronans within 6 months or within 1 month if there was no sustained improvement post-injection of either corticosteroid or hyaluronan.
• history of trauma to this knee in the last year that clearly caused the pain now present
• history of RA, gout, pseudogout, hemarthroses (eg, hemophilic arthropathy) or other inflammatory arthritis involving this knee
• history of symptomatic hip OA
• history of psychosis, personality disorder, uncontrolled affective disorder
• history of fibromyalgia
• malignancy requiring active treatment
• current regular use of opiate analgesics, PRP, or acupuncture for the knees

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Stephen P. Merry, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Paul D. Brown, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Family Medicine Research Study Coordinators

CONTACT

507-422-6823; RSTFMSC@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 20, 2025
• Study Start: June 4, 2025
• Primary Completion (Estimated): June 28, 2026
• Study Completion (Estimated): June 29, 2026
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)