CoxarthrosisPhase 3COXNCT02694146
Clinical Trial to Evaluate the Use of Platelet Rich Plasma in Front Hyaluronic Acid in Coxarthrosis
A Phase 3 study testing Platelet rich plasma and Hylan G-F 20 in people with Coxarthrosis, run by Fundación Pública Andaluza Progreso y Salud at 2 sites in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Coxarthrosis
- What is being tested?
- Platelet rich plasma and Hylan G-F 20
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 2 sitesSpain
- Study dates
- Mar 2016to May 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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)
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Complejo Hospitalario de Pontevedra
Pontevedra, 36002
Hospital Universitario Virgen Macarena
Seville, 41009
About this study
Official title: Clinical Trial Randomized, Double-blind Controlled, Phase III, to Evaluate the Use of Platelet Rich Plasma in Front Hyaluronic Acid in Coxarthrosis
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).
- Conditions
- Coxarthrosis
- Being tested
- Platelet rich plasma, Hylan G-F 20
- Keywords
- platelet-rich plasma (PRP), hyaluronic acid (Hylan G-F 20)., NSAIDs, WOMAC
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich plasmaDrug
Also called PRP
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 20Drug
Also called Synvisc-One
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Platelet rich plasma |
| 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. Receives: Drug: Hylan G-F 20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 1 year.
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.
Measured: Through study completion, an average of 1 year.
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).
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoxarthrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza Progreso y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luis Javier Roca Ruiz, Graduate, Principal investigator, Hospital Universitario Virgen Macarena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02694146
- Sponsor's protocol ID
- COX1985
- Other IDs
- 2014-004120-21, 2014
- Acronym
- COX
- Status last verified
- May 2017
- First submitted
- 9 Feb 2016
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Randomized, Double-blind Controlled, Phase III, to Evaluate the Use of Platelet Rich Plasma in Front Hyaluronic Acid in Coxarthrosis
- ClinicalTrials.gov ID
- NCT02694146
- Acronym / sponsor ID
- COX / COX1985
- Conditions
- Coxarthrosis
- Keywords
- platelet-rich plasma (PRP), hyaluronic acid (Hylan G-F 20)., NSAIDs, WOMAC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza Progreso y SaludUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 29 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP (platelet rich plasma) | Experimental | Drug: Platelet rich plasma37 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 | Drug: Hylan G-F 2037 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. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet rich plasmaAlso: PRPPlatelet 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). | Drug | PRP (platelet rich plasma) |
| Hylan G-F 20Also: Synvisc-OneHylan 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. | Drug | Hylan G-F 20 (Synvisc-One ®) |
Primary outcome
EVA scale for pain measure.
Time frame: Through study completion, an average of 1 year.
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.
Time frame: Through study completion, an average of 1 year.
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.
Time frame: Through study completion, an average of 1 year.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis Javier Roca Ruiz, Graduate principal investigator
Hospital Universitario Virgen Macarena
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Platelet rich plasma and Hylan G-F 20 in people with Coxarthrosis, run by Fundación Pública Andaluza Progreso y Salud at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EVA scale for pain measure. (time frame: Through study completion, an average of 1 year.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2019.