Painful syndrome of the greater trochanter (chronic GTPS)
Conditions
Interventions
Product Name: Platelets Rich Plasma
Product Code: PRP
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Platelet Rich Plasma
Sponsors
ISABEL ANDIA ORTIZ
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 683/5000 - Patients of both sexes aged between 35 and 75 years. - In the selection visit, they present hip pain at 3 points out of 10 in EVA. - Body Mass Index values between 20 and 35 (both values included). - Commitment to comply with all the study procedures. - Diagnosed chronic GTPS according to the diagnostic criteria that have been previously described. - The patient must give his informed consent in writing. - Women of childbearing potential must obtain a negative result in the blood or urine pregnancy test and accept the use of adequate contraceptive methods while remaining 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 80 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Body mass index> 35. - Patients with a diagnosis of complete tendon rupture. - Systemic autoimmune rheumatic disease (connective tissue diseases and systemic necrotizing vasculitis). - Diabetes Mellitus poorly controlled (glycosylated hemoglobin greater than 9%). - Hematological alterations (thrombopathy, thrombocytopenia, anemia with Hb <9 gr / dl). - Being subjected to immunosuppressive treatments. - Treatment by intramuscular corticoid, during the 3 months prior to the first administration of the trial treatment. - Treatment by non-steroidal anti-inflammatory drugs (more than 10 consecutive days at usual doses), opiates or oral corticosteroids during the 15 days prior to treatment in the study. - Severe heart disease. - Patients who can not comply with the scheduled visits. - Patients with active cancer or with cancer diagnosed in the last 5 years. - Analytical diagnosis of Hepatitis B, C or HIV infection. - Women who are pregnant or breast-feeding. - Patients who are taking a drug in the clinical research phase or have participated in a study in the clinical research phase (with an authorized product or not) within 30 days prior to randomization. - Any physical, social or psychological problem that, in the opinion of the investigators, may affect the patient's participation in the trial or the validity of the data obtained by participating in it.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The difference in the percentage of therapeutic success obtained in the intervention group (fenestration with PRP) with respect to the group of wet tenotomy with lidocaine.;Timepoint(s) of evaluation of this end point: 6 months from the end of the treatment.;Main Objective: Assess the potential efficacy of fenestration with PRS tendon in the symptomatic treatment of chronic GTPS versus wet tenotomy with lidocaine by comparing the success rate at follow-up visit 2 (6 months after treatment), between the groups of fenestration with PRP and wet tenotomy with lidocaine.;Secondary Objective: Assess the safety of fenestration with PRP in the symptomatic treatment of chronic GTPS versus wet tenotomy with lidocaine through: a) comparing the frequency, intensity and severity of adverse events and adverse reactions in the period between initial visit and three months after the treatment visit (follow-up visit 1) To evaluate the potential efficacy of fenestration with PRP tendon in the symptomatic treatment of chronic GTPS versus wet tenotomy with lidocaine by comparing the rate of success in the follow-up visit 2 (6 months from the treatment), between the groups of fenestration with PRP and wet tenotomy with lidocaine. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Description of frequency, type, intensity and severity of adverse events and adverse reactions in each treatment group in the period between the initial visit and three months after the treatment visit and comparison between groups.;Timepoint(s) of evaluation of this end point: 6 months from the end of the treatment. | — |
Countries
Spain
Contacts
Public ContactClinical Trial Information
LEIRE ATILANO SANTOS
Outcome results
None listed