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Clinical Trial to Evaluate the Use of Platelet Rich Plasma in Front Hyaluronic Acid in Coxarthrosis (COX)

Primary Purpose

Coxarthrosis

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Platelet rich plasma
Hylan G-F 20
Sponsored by
Fundación Pública Andaluza Progreso y Salud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coxarthrosis focused on measuring platelet-rich plasma (PRP), hyaluronic acid (Hylan G-F 20)., NSAIDs, WOMAC

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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)

Sites / Locations

  • Complejo Hospitalario de Pontevedra
  • Hospital Universitario Virgen Macarena

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PRP (platelet rich plasma)

Hylan G-F 20 (Synvisc-One ®)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

EVA scale for pain measure.
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.
Harris Hip Score for pain, function and range of motion measure.
It is a questionnaire developed to evaluate hip surgery or replacement. It is widely used for evaluation of hip disorders and treatment methods.
WOMAC questionnaire for pain, stiffness and joint mobility measure.
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).

Secondary Outcome Measures

Full Information

First Posted
February 9, 2016
Last Updated
February 21, 2019
Sponsor
Fundación Pública Andaluza Progreso y Salud
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1. Study Identification

Unique Protocol Identification Number
NCT02694146
Brief Title
Clinical Trial to Evaluate the Use of Platelet Rich Plasma in Front Hyaluronic Acid in Coxarthrosis
Acronym
COX
Official Title
Clinical Trial Randomized, Double-blind Controlled, Phase III, to Evaluate the Use of Platelet Rich Plasma in Front Hyaluronic Acid in Coxarthrosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Pública Andaluza Progreso y Salud

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the efficacy and safety of platelet rich plasma (PRP) in patients with coxarthrosis who don´t respond to treatment with NSAIDs, compared to treatment with hyaluronic acid (Hylan G-F 20).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coxarthrosis
Keywords
platelet-rich plasma (PRP), hyaluronic acid (Hylan G-F 20)., NSAIDs, WOMAC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRP (platelet rich plasma)
Arm Type
Experimental
Arm Description
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.
Arm Title
Hylan G-F 20 (Synvisc-One ®)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Platelet rich plasma
Other Intervention Name(s)
PRP
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Hylan G-F 20
Other Intervention Name(s)
Synvisc-One
Intervention Description
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.
Primary Outcome Measure Information:
Title
EVA scale for pain measure.
Description
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.
Time Frame
Through study completion, an average of 1 year.
Title
Harris Hip Score for pain, function and range of motion measure.
Description
It is a questionnaire developed to evaluate hip surgery or replacement. It is widely used for evaluation of hip disorders and treatment methods.
Time Frame
Through study completion, an average of 1 year.
Title
WOMAC questionnaire for pain, stiffness and joint mobility measure.
Description
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).
Time Frame
Through study completion, an average of 1 year.
Other Pre-specified Outcome Measures:
Title
Adverse events.
Description
All adverse events (AEs) are recorded in the case report data from the time that the patient sign the informed consent, indicating the nature of adverse events and their description in both: the experimental group and the comparator.
Time Frame
Through study completion, an average of 1 year.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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. 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis Javier Roca Ruiz, Graduate
Organizational Affiliation
Hospital Universitario Virgen Macarena
Official's Role
Principal Investigator
Facility Information:
Facility Name
Complejo Hospitalario de Pontevedra
City
Pontevedra
ZIP/Postal Code
36002
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Clinical Trial to Evaluate the Use of Platelet Rich Plasma in Front Hyaluronic Acid in Coxarthrosis

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