search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


FermaTrial: a study on the treatment of osteoarthritis by means of injections in the hip joint.


- candidate number16912
- NTR NumberNTR4373
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-mrt-2014
- Secondary IDsNL44152.099.13 
- Public TitleFermaTrial: a study on the treatment of osteoarthritis by means of injections in the hip joint.
- Scientific TitleLongterm effects of intra-articular hyaluronan (Fermathron S) vs corticosteroids (Depomedrol) in osteoarthritis of the hip: A randomized controlled trial.
- ACRONYMFermaTrial
- hypothesisThe positive short term effects of intra-articular injections with corticosteroids and hyaluronic acid are known. However, the longterm effects are unknown.
- Healt Condition(s) or Problem(s) studiedArthrosis, Hip
- Inclusion criteria1. Age 18 years or older 2. Symptomatic coxarthritis 3. Baseline hip pain VAS score of 15 mm or more 4. Signed informed consent
- Exclusion criteria1. Ipsilateral gonarthritis 2. Clinical significant neurologic or vascular disease 3. Previous intra-articular injections in the affected hip 4. Osteonecrosis or osteomyelitis of the affected hip 5. Rheumatoid arthritis or other inflammatory arthrides 6. Previous surgical procedures of the hip 7. Active or suspected infection in or around the hip 8. Limitation to give an intra-articular injection in the affected hip 9. Current treatement with corticisteroids for another disease 10. Serious liver or kidney failure 11. An alcohol or drug addiction 12. Pregnancy or breastfeeding 13. Contraindications to components of Fermatron, Depomedrol or lidocaine
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2014
- planned closingdate1-mei-2017
- Target number of participants188
- InterventionsGroup I: 3 ml hyaluronic acid and 2 ml lidocaine Group II: 2 ml corticosteroids and 3 ml lidocaine
- Primary outcomeDifferences in pain reduction between patients with osteoarthritis of the hip treated with intra-articular injections with Fermathron S (hyaluronic acid) and patients treated with corticosteroids (Depomedrol).
- Secondary outcome1. Differences in function and radiological changes between the group treated with Fermathron S and the group treated with Depomedrol. 2. Safety of Fermathron S in patients with osteoarhritis of the hip. 3. Differences in paracetamol consumption between the group treated with Fermathron S and the group treated with Depomedrol.
- TimepointsAt 6 and 12 months follow-up
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. P.C. Rijk
- CONTACT for SCIENTIFIC QUERIESDr. P.C. Rijk
- Sponsor/Initiator Medical Center Leeuwarden
- Funding
(Source(s) of Monetary or Material Support)
Hyaltech LTD, Edingburgh, Scotland, Stichting Onderzoek Leeuwarder
- Publications
- Brief summaryBackground of the study: Conservative treatment concerning coxarthosis has been limited to pain medication and physical therapy. Also known are the positive short term effects of intra-articular injections with corticosteriods and hyaluronic acid. However, the long term effects are unknown. Study design: Multi centre randomised, blinded and prospective trial consisting of two groups; (I) Hyaluronic acid (Fermathron S) and (II) Corticosteriods (Depomedrol). Intervention: Group I will recieve 3 ml hyaluronic acid and 2 ml Lidocaine. Group II will receive 2 ml corticosteriods and 3 ml Lidocaine. Primary outcome: To determine differences in pain reduction between patients with osteoarthritis of the hip treated with intra-articular injections with Fermathron S (hyaluronic acid) and patients treated with Depomedrol (corticosteroids) at 6 and 12 months follow-up.
- Main changes (audit trail)
- RECORD20-mrt-2014 - 26-mrt-2014


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl