"Transarterial Microembolization (TAME) in Inflammatory Knee Pathology"
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorIstituto Ortopedico Rizzoli
About this trial
Patients with knee OA and chronic pain refractory to at least 3 months of conventional conservative therapy will be included in the study, which will evaluate the clinical results obtained after treatment with selective arterial embolization (selection and enrollment, treatment with selective arterial embolization, follow-up checks). Forty-three patients will be included in the study and will undergo the transarterial microembolization procedure after signing the informed consent form for participation in the study and the collection of anamnestic data. Subsequently, patients will be followed up with clinical evaluation at 1, 3, 6, 12, and 24 months of follow-up or until possible dropout for other treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age over 40 years;
Moderate knee OA (grade 2-3 according to the Kellgren-Lawrence score) for which an indication for total knee arthroplasty surgery has already been given;
Knee OA with an inflammatory component (night pain, pain at rest, recurrent episodes of effusion, swelling and/or redness);
Persistent and moderate or severe knee pain (VAS score > 4);
Disqualifiers
Mentally incompetent patients;
Patients with trauma in the 6 months prior to treatment;
Patients with malignant neoplasms;
Patients with rheumatic diseases;
Trial population
Patients affected by inflammatory arthropathy of the knee who underwent genicular artery microembolization.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Transarterial Microembolization
Procedure/SurgeryIdentification of the hypervascularization of the knee. Selective and super-selective catheterization of pathological genicular arterial branches, through the use of micro-catheters. - Injection of embolizing material (Nexsphere-F - Kardia) - Control of technical success: the embolization will be followed by diagnostic arteriography that will evaluate the success of the procedure (occlusion of more than 90 percent of the pathologic vasculature).
Treatment groups
43 Participants
are divided into 1 treatment groupGroup A: Performed microembolization1 intervention
Trial outcomes
Primary outcomes
1
Reduction of pain (VAS score)
Clinical assessment regarding pain by Visual Analogue Scale (VAS) score (0-100 mm), in which 0 represents no pain, and 100 represents maximum pain imaginable.
Time frame
1 yearSecondary outcomes
1
Improvement in quality of life (SF-36)
Clinical assessment regarding quality of life by SF-36 questionnaire. The SF-36 is a widely used tool to measure health-related quality of life. It has 36 questions covering 8 domains: Physical Functioning, Role Limitations due to Physical Health, Bodily Pain, General Health, Vitality, Social Functioning, Role Limitations due to Emotional Problems, Mental Health. Plus, there is one item on health change over the past year. Scoring: Once items are recoded so that higher scores always = better health, domain scores are computed by averaging item scores, then transforming to a 0-100 scale (0 = worst health, 100 = best).
Time frame
2 years2
Pain, stiffness, and physical functioning of the joints (WOMAC score)
It measures 5 items for pain (range 0-20), two for stiffness (range 0-8), and 17 for functional limitation (range 0-68), which mainly concern daily activities (e.g., getting up from a sitting position, bending over, going up and down stairs, etc.). The score is then normalized on a scale of 0-100. Higher values indicate a worse outcome.
Time frame
2 years3
Range of motion
Objective parameter used to assess joint mobility and functional ability. \- Good/Normal ROM: Extension: 0° (up to -5°/-10° hyperextension can be physiological). Flexion: 130°-150°. \- Clinically acceptable ("good enough" for daily life): Flexion \>120°. Full extension (0°) is essential; even small deficits are significant. \- Reduced: Flexion \<110°. Extension loss \>5°.
Time frame
2 years4
Overall assessment of treatment
The patient will be asked to indicate their level of satisfaction (on a scale from 0 to 10) with the treatment received at each follow-up visit during the clinical trial.
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Istituto Ortopedico Rizzoli
Lead sponsor
Ospedale San Giuseppe Moscati, Avellino
Collaborator
Azienda Ospedaliero-Universitaria, Catania
Collaborator
Azienda Ospedaliera di Perugia
Collaborator
San Salvatore Hospital, AST Pesaro-Urbino
Collaborator
A.O.U. Città della Salute e della Scienza - Molinette Hospital
Collaborator
Source ClinicalTrials.gov