Gonarthrosis Clinical Trial
Official title:
Three vs Six Gy in Gonarthrosis and Coxarthrosis. Non Inferiority Study
This is a non-inferiority study in which the investigators compare two low-dose radiotherapy
schemes, which are recommended from DEGRO Clinical Practice Guidelines (3 Gy vs 6 Gy) for the
treatment of osteoarthritis and other osteodegenerative disorders.
A first randomization will be carried out among the patients included in the study:
- Patients in arm A will be treated at 3 Gy (0.5 Gy/fraction, 3 fractions/week), and
patients in arm B will be treated at 6 Gy (1 Gy/fraction, 3 fractions/week).
- Patients should not know the arm to which they have been randomized.
- Once the treatment is finished, patients will be assessed at 8 weeks. If pain does not
improve, a re-irradiation will be performed. If the patients were treated with 3 Gy a
new randomization will be performed (3 vs 6 Gy again). If the patiens were treated with
6 Gy they will be re-irradiated with 6 Gy again.
The investigators will analyze the results obtained depending on the dose received and
depending on the location of the treatment.
Painfull skeletal disorders are susceptible to be treated with low-dose radiotherapy. DEGRO
guidelines recommend a dose between 3 and 6 Gy at 0'5 Gy/fraction or 1 Gy/fraction
respectively. The investigators want to verify that both treatments (3 and 6 Gy) are similar
to improve the pain and function in patiens with gonarthrosis and coxarthrosis, and there are
no differences between both treatments, therefore, 3 Gy is not less than 6 Gy.
In this context, a prospective multicenter study is proposed. The study will include 338
patients to assess the efficacy of low dose irradiation (3 vs 6 Gy) in gonarthrosis and
coxarthrosis.
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