CLINICAL TRIAL RANDOMIZED, DOUBLE-BLIND CONTROLLED, PHASE III, TO EVALUATE THE USE OF PLATELET RICH PLASMA IN FRONT HYALURONIC ACID IN COXARTHROSIS.

Phase 1

• Conditions: coxarthrosis; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]; MedDRA version: 18.0Level: PTClassification code 10058417Term: Hyaluronic acidSystem Organ Class: 10022891 - Investigations

• Registration Number: EUCTR2014-004120-21-ES
• Lead Sponsor: FUNDACIÓN PÚBLICA ANDALUZA PROGRESO Y SALUD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-15
• Last Update Posted: 24 September 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

- Patients> 30 years.
- Patients who voluntarily express their intention to participate by informed consent.
- Diagnosis of coxarthrosis who have failed conservative treatments for 6 months
- Women of childbearing potential must have a negative pregnancy test during screening and must agree to use adequate contraception (or two contraceptive methods, of which one is barrier) while participating in the trial.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

- Treatment with infiltrations 3 months prior to the study
- Prior treatment with NSAIDs 24h prior to extraction
- Pre-Surgical Treatment of Hip affects
- Diabetics
- Severe liver or kidney disease at the time of extraction
- Thrombocytopenia (<100,000 platelets / ml) at baseline
- Anemia (Hb 9 - Hyaluronic acid Allergy
- History crystal arthropathy, inflammatory arthritis or neuropathic arthropathy.
- Acetabular protrusions
- History of infectious arthritis
- Excessive deformity (acetabular dysplasia, Perthes)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy and safety of platelet rich plasma (PRP) in patients with coxarthrosis;Secondary Objective: To evaluate the efficacy and safety of platelet rich plasma (PRP) in patients with coxarthrosis;Primary end point(s): An analysis of qualitative endpoint WOMAC (range 0-100) between the two treatment groups at month infiltration is performed. To evaluate the functional differences of both groups the Student t test or nonparametric variant in the case of not meeting the normal distribution is used.;Timepoint(s) of evaluation of this end point: An analysis of qualitative endpoint WOMAC (range 0-100) between the two treatment groups at month infiltration is performed. To evaluate the functional differences of both groups the Student t test or nonparametric variant in the case of not meeting the normal distribution is used.