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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004120-21-ES

Enrollment

Registered

2015-06-15

Start date

2016-01-22

Completion date

Unknown

Last updated

2018-09-24

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

Conditions

coxarthrosis MedDRA version: 18.0 Level: PT Classification code 10058417 Term: Hyaluronic acid System Organ Class: 10022891 - Investigations

Interventions

Product Name: platelet rich plasma Pharmaceutical Form: Injection INN or Proposed INN: Platelet rich plasma Other descriptive name: AUTOLOGOUS PLASMA Concentration unit: ml millilitre(s) Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

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

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 <mg / dl) at baseline - Hyaluronic acid Allergy - History crystal arthropathy, inflammatory arthritis or neuropathic arthropathy. - Acetabular protrusions - History of infectious arthritis - Excessive deformity (acetabular dysplasia, Perthes)

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
Secondary end point(s): To evaluate the correlation of platelet concentration and the concentration values of different chondrocyte growth factors with clinical response test bivariate Pearson correlation or nonparametric alternative (Spearman's Rho) will be used. This evaluation will be done by measuring the WOMAC scale a week and a month. To assess the various factors together with clinical response of the patient will be done through a linear regression model. This model also values the baseline characteristics of patients and the severity of coxarthrosis measured by the scale of Tönnis, BMI, seasonality data, disease progression is included.;Timepoint(s) of evaluation of this end point: To evaluate the correlation of platelet concentration and the concentration values of different chondrocyte growth factors with clinical response test bivariate Pearson correlation or nonparametric alternative (Spearman's Rho) will be used. This evaluation will be done by measuring the WOMAC scale a week and a month. To assess the various factors together with clinical response of the patient will be done through a linear regression model. This model also values the baseline characteristics of patients and the severity of coxarthrosis measured by the scale of Tönnis, BMI, seasonality data, disease progression is included.	—

Measure

Time frame

Secondary end point(s): To evaluate the correlation of platelet concentration and the concentration values of different chondrocyte growth factors with clinical response test bivariate Pearson correlation or nonparametric alternative (Spearman's Rho) will be used. This evaluation will be done by measuring the WOMAC scale a week and a month. To assess the various factors together with clinical response of the patient will be done through a linear regression model. This model also values the baseline characteristics of patients and the severity of coxarthrosis measured by the scale of Tönnis, BMI, seasonality data, disease progression is included.;Timepoint(s) of evaluation of this end point: To evaluate the correlation of platelet concentration and the concentration values of different chondrocyte growth factors with clinical response test bivariate Pearson correlation or nonparametric alternative (Spearman's Rho) will be used. This evaluation will be done by measuring the WOMAC scale a week and a month. To assess the various factors together with clinical response of the patient will be done through a linear regression model. This model also values the baseline characteristics of patients and the severity of coxarthrosis measured by the scale of Tönnis, BMI, seasonality data, disease progression is included.

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Countries

Spain

Contacts

Public ContactMARTA REBOREDO ARES

FUNDACIÓN PÚBLICA ANDALUZA PROGRESO Y SALUD

gestionensayosclinicos.fps@juntadeandalucia.es0034955040450

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026