Status:
COMPLETED
Effectiveness of Intra-articular Oxygen-ozone Injections and Splinting for the Treatment of Thumb Osteoarthritis
Lead Sponsor:
Humanitas Clinical and Research Center
Conditions:
Thumb Osteoarthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Osteoarthritis of trapezio-metacarpal joint (TMJ) most commonly occurs in women over 50 years old, often bilateral and it is a disabling condition presenting with pain at base of the thumb, swelling, ...
Detailed Description
Osteoarthritis is a degenerative condition that causes pain, impaired function and affects daily activities. In osteoarthritis, there is the destruction of cartilage and subchondral bone, with the con...
Eligibility Criteria
Inclusion
- Exclusion Criteria:
- Presence of clinically observed active infection or severe inflammation in the index trapezio-metacarpal joint or skin disease/breakdown or infection in the area of the planned injection site of the index thumb joint.
- Diagnosed with rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis, or arthritis secondary to other inflammatory diseases; Human Immunodeficiency Virus (HIV), viral hepatitis; chondrocalcinosis, Paget's disease, or villonodular synovitis.
- Diagnosed with leukaemia, known presence of metastatic malignant cells, or ongoing or planned chemotherapeutic treatment.
- Disease of cervical spine, shoulder or other upper extremity joints judged by the investigator to be contributing to the pain in the index thumb joint (e.g. radiculopathy, De Quervain S., etc.).
- Untreated symptomatic injury of the index hand (e.g., acute traumatic injury, tendinopathy, nerve lesion).
- Presence of surgical hardware or other foreign body intended to treat arthritis or cartilage-related pathology in the index thumb joint.
- Presence of venous or lymphatic stasis in the index arm.
- Orally administered systemic steroid use within 2 weeks prior to screening
- Planned/anticipated surgery of the index hand during the study period.
- Major surgery of the index hand within 12 months prior to screening.
- Minor surgery (e.g. arthroscopy) of the index hand within 6 months prior to screening
- Any documented clinically significant degree of cognitive impairment or other condition, finding, or psychiatric illness at screening, which, in the opinion of the investigator, could compromise patient safety or interfere with the assessment of the safety and treatment effects of the study injection.
- Pregnant or nursing mothers or women planning to become pregnant during the time they will be participating in the study.
- Previously documented failed treatment with OOT or splint
- Known drug or alcohol dependence currently or within the last year.
- Use of any investigational drug or device within 30 days prior to screening.
- Use of any investigational biologics within 60 days prior to screening.
Exclusion
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2022
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT07171840
Start Date
May 1 2021
End Date
December 23 2022
Last Update
September 26 2025
Active Locations (1)
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1
Humanitas Research Hospital
Rozzano, Milano, Italy, 20089