Radiotherapy 3 vs 6 Gy in Gonarthrosis and Coxarthrosis
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- STATUS
- Recruiting
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- participants needed
- 338
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- sponsor
- Fundacion GenesisCare
Summary
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.
Description
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.
Details
| Condition | Osteoarthritis of hip, Osteoarthritis, Osteoarthritis, Gonarthrosis |
|---|---|
| Age | 50years - 100years |
| Treatment | Low dose radiotherapy A, Low dose radiotherapy B |
| Clinical Study Identifier | NCT04424628 |
| Sponsor | Fundacion GenesisCare |
| Last Modified on | 19 February 2024 |
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