Patients with Painful, low-grade* osteoarthritis of the hip who present themselves at the orthopedic outpatient clinic of Orbis Medisch Centrum·
Conditions
Interventions
The study design is a prospective, double-blind, randomized trial. We will include 60
patients with early osteoarthritis of the hip, not willing or not able to undergo
surgery. The patients will be re
Sponsors
dr E.J.P. Jansen
Orthopedic surgeon
Atrium-Orbis MC
Sittard-Geleen
Eligibility
Inclusion criteria
Inclusion criteria: · Painful, low-grade* osteoarthritis of the hip · Above 50 years old · Synovitis confirmed with ultrasound imaging · Ability and willingness to follow instructions and to return for follow-up evaluations *: Kellgren-Lawrence grade I-II
Exclusion criteria
Exclusion criteria: · Patients diagnosed with reumathoid arthritis · Patients with osseous metastasis · Patients with rheumatoid factor > 20 kU/l or blood sedimentation rate > 20mm · Patients with a moderate or severe osteoarthritis grade** · Patients with a hip/spine dilemma · Prostethic implant in the affected joint · Not able or willing to undergo bone scintigraphy or blood sampling **: Kellgren-Lawrence grade III-IV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the effect of LDRT on pain sensation after 1,2,3,6 months in early osteoarthritis of the hip, measured with a Visual Analogue Scale (VAS), compared to placebo 'sham' irradiation and standard-of-care conservative treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| · To determine the effect of LDRT on patient reported outcome measures (PROM) including WOMAC and Oxford Hip Score. · To determine the effect of LDRT on quality of life, assessed with the EuroQoL- 5D questionnaire. · To investigate the relationship between effect of LDRT and level of synovitis, measured through ultrasound, bone scintigraphy and blood BSE level. | — |
Contacts
Public ContactM.G.M. Schotanus
Department of Orthopedic Surgery, Orbis Medisch Centrum dr H vd Hoffplein 1
Outcome results
None listed