MedTrace Logo

Radiotherapy 3 vs 6 Gy in Gonarthrosis and Coxarthrosis

NCT04424628 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 338

Last updated 2020-06-22

No results posted yet for this study

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.

Conditions

  • Gonarthrosis
  • Coxarthrosis

Interventions

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

Sponsors & Collaborators

  • Elekta Limited

    collaborator INDUSTRY

  • Fundacion GenesisCare

    lead NETWORK

Principal Investigators

  • Daniel Rivas Sanchez, MD · Fundacion GenesisCare

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2021-04-30
Completion
2023-04-30

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04424628 on ClinicalTrials.gov