NCT04424628

Radiotherapy 3 vs 6 Gy in Gonarthrosis and Coxarthrosis

Three vs Six Gy in Gonarthrosis and Coxarthrosis. Non Inferiority Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 338 (estimated)
• Sponsor: Fundacion GenesisCare · Network
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Gonarthrosis
• Coxarthrosis

Interventions

Type	Name	Description
RADIATION	Low dose radiotherapy A	Low dose radiotherapy was 0.5 Gy in 6 fractions. Evaluation of pain and Quality of Life in 8-12 weeks. If no pain releave the patient is randomized to 3 or 6 Gy again
RADIATION	Low dose radiotherapy B	Low dose radiotherapy was 0.5 Gy in 6 fractions. Evaluation of pain and Quality of Life in 8-12 weeks. If no pain releave the patient is treated with 6 Gy again

Timeline

• Start date: 2019-05-01
• Primary completion: 2021-04-30
• Completion: 2023-04-30
• First posted: 2020-06-11
• Last updated: 2020-06-22

Locations

1 site across 1 country: Spain