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

Longterm effects of intra-articular hyaluronan (Fermathron S) vs corticosteroids (Depomedrol) in osteoarthritis of the hip: A randomized controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24527
Enrollment
188
Registered
2014-03-20
Start date
2014-05-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthrosis Hip

Interventions

Group I: 3 ml hyaluronic acid and 2 ml lidocaine Group II: 2 ml corticosteroids and 3 ml lidocaine

Sponsors

Maatschap Orthopedie, Medisch Centrum Leeuwarden
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18 years or older 2. Symptomatic coxarthritis 3. Baseline hip pain VAS score of 15 mm or more 4. Signed informed consent

Exclusion criteria

Exclusion criteria: 1. 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

Design outcomes

Primary

MeasureTime frame
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 corticosteroids (Depomedrol).

Secondary

MeasureTime frame
1. 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.

Contacts

Public ContactP.C. Rijk

Henri Dunantweg 2 8934 AD Leeuwarden The Netherlands

+(0)58-2867666

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)