Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02694146 | Clinical Trial to Evaluate the Use of Platelet Rich Plasma in Front Hyaluronic Acid in Coxarthrosis | PHASE3 | COMPLETED | 74 | — | — | Mar 1, 2016 | May 1, 2018 | Feb 22, 2019 | 2 | Spain |
The patient assesses the sensation of pain following a horizontal visual analog scale (EVA) with values between 0 ("no pain") and the value 100 ("excruciating pain"). The records taken are recorded in the medical record of the patient.
It is a questionnaire developed to evaluate hip surgery or replacement. It is widely used for evaluation of hip disorders and treatment methods.
It is a standardized questionnaire, widely used for assessment of both knee and hip osteoarthritis. It consists of five items for assessing pain (range 0-20), two items that assess the stiffness (range 0-8) and 17 items that evaluate the functionality of the joint (range 0-68).
| Arm | Type | Description |
|---|---|---|
| PRP (platelet rich plasma) | EXPERIMENTAL | 37 patients with coxarthrosis are treated with 6ml of PRP (platelet rich plasma), obtained from blood extracted from patients in the 20 minutes prior to infiltration thereof. For PRP administration: * The injection should be performed at room temperature. * The administration should be carried out under aseptic conditions. * The patient will be placed in the supine position and the administration will be performed by an anterolateral approach. * The PRP is injected into the synovial space. |
| Hylan G-F 20 (Synvisc-One ®) | ACTIVE_COMPARATOR | 37 patients with coxarthrosis are treated with a pre-filled syringe of hyaluronic acid 60mg / 6ml (Synvisc-One ®). It is necessary to remove synovial fluid before injecting Hylan G-F 20. * The injection should be performed at room temperature. * The administration should be carried out under aseptic conditions. * The patient will be placed in the supine position and the administration will be performed by an anterolateral approach. * The Hylan G-F 20 is injected into the synovial space. * After injecting Hylan G-F 20 the patient should stand 5 minutes. |
| Name | Type | Description |
|---|---|---|
| Platelet rich plasma | DRUG | Platelet rich plasma (PRP) is a platelet concentrated obtained from autologous blood centrifugation. This concentration technique provides larger amounts of biologically active molecules, mainly growth factors that are responsible for tissue repair. PRP (platelet rich plasma) contains a higher concentration of platelets from baseline (150,000-350,000 / ul). |
| Hylan G-F 20 | DRUG | Hylan G-F 20 is a viscous, sterile and non-pyrogenic elasto fluid containing hylan. Hylans are byproducts from hyaluronate (hyaluronic acid sodium salt), consisting of repeating disaccharides of N-acetylglucosamine and sodium glucuronate. Hylan G-F 20 replaces and supplements the synovial fluid. It is effective at any stage of the joint pathology. |
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 a...