Hip OsteoarthritisNCT04820231
Platelet-Rich Plasma and Hip Osteoarthritis
A study testing intra-articular PRP injection in people with Hip Osteoarthritis, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
To evaluate the effect of platelet-rich plasma (PRP) injection on pain, function and quality of life in patients with hip osteoarthritis. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- intra-articular PRP injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2017to Jan 2018
- Phase
- Interventional
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hip pain VAS > 4
- Grade 1 and 2 osteoarthritis according to the Kellgren-Lawrence classification
- No pathologies in the laboratory and coagulation parameters
Who cannot join
- Rheumatological disease with hip involvement
- Systemic active infection
- Severe cardiovascular disease
- Malignancy
- NSAID usage in the last week
- History of hip joint surgery
Show all 10Show fewer
- History of traumatic hip injury
- Hgb values < 11 gr/dl
- Platelets values < 150.000 / µl
- History of bleeding disorder
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Şişli Hamidiye Etfal Training and Research Hospital
Istanbul, Şişli, 34371
About this study
Official title: The Effect of Platelet-Rich Plasma Injection on Pain, Function and Quality of Life in Patients With Hip Osteoarthritis
To evaluate the effect of platelet-rich plasma (PRP) injection on pain, function and quality of life in patients with hip osteoarthritis.
Read the detailed description
After being informed about the study and potential risk, all patients giving written informed consent will undergo study entry.
Each patient received three times intra-articuler injections of PRP under ultrasound guidance, and they were administered once a week.
Baseline: Visual Analog Scale (VAS) including movement, rest and night, the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) and SF-36 assessment
1st month: VAS, WOMAC and SF-36 assessment
3rd month: VAS, WOMAC and SF-36 assessment
6th month: VAS, WOMAC and SF-36 assessment
- Conditions
- Hip Osteoarthritis
- Being tested
- intra-articular PRP injection
- Keywords
- hip osteoarthritis, platelet-rich plasma, ultrasound guidance
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intra-articular PRP injectionOther
| Study group | Role | What they receive |
|---|---|---|
| PRP injection group | Other | Intra-articular PRP injection with ultrasound guidance
Three times PRP injections with an interval of one week Receives: Other: intra-articular PRP injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Visual Analog Scale (VAS) score at 1-month, 3-month and 6-month
The VAS is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 'no pain' and 'worst pain'.
Measured: Baseline, 1st month, 3rd month, 6th month
Change from baseline Western Ontario and McMaster University Osteoarthritis Index (WOMAC) score at 1-month, 3-month and 6-month
The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score, however there are other methods that have been used to combine scores.
Higher scores: worse pain, stiffness, and functional limitations.
Measured: Baseline, 1st month, 3rd month, 6th month
Change from baseline SF-36 score at 1-month, 3-month and 6-month
The SF-36 is a 36-item self-report measure of health-related quality of life. It has eight subscales measuring different domains of health-related quality of life: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health . Two component scores are derived from the eight subscales: a physical health component score and a mental health component score.
High scores: good quality of life
Measured: Baseline, 1st month, 3rd month, 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study startJan 2017
- Primary completionJul 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The patients with mono-lateral hip pain , grade 1 or 2 hip osteoarthritis according to the Kellgren-Lawrence classification
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selda Çiftci, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- Jülide Öncü Alptekin, Study chair, Şişli Hamidiye Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04820231
- Sponsor's protocol ID
- 191
- Status last verified
- Mar 2021
- First submitted
- 23 Mar 2021
- Last updated
- 29 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Platelet-Rich Plasma Injection on Pain, Function and Quality of Life in Patients With Hip Osteoarthritis
- ClinicalTrials.gov ID
- NCT04820231
- Acronym / sponsor ID
- 191
- Conditions
- Hip Osteoarthritis
- Keywords
- hip osteoarthritis, platelet-rich plasma, ultrasound guidance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 29 Mar 2021 (actual)
- 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 effect of platelet-rich plasma (PRP) injection on pain, function and quality of life in patients with hip osteoarthritis.
Detailed description
After being informed about the study and potential risk, all patients giving written informed consent will undergo study entry.
Each patient received three times intra-articuler injections of PRP under ultrasound guidance, and they were administered once a week.
Baseline: Visual Analog Scale (VAS) including movement, rest and night, the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) and SF-36 assessment
1st month: VAS, WOMAC and SF-36 assessment
3rd month: VAS, WOMAC and SF-36 assessment
6th month: VAS, WOMAC and SF-36 assessment
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The patients with mono-lateral hip pain , grade 1 or 2 hip osteoarthritis according to the Kellgren-Lawrence classification
| Arm | Type | Receives |
|---|---|---|
| PRP injection group | Other | Other: intra-articular PRP injectionIntra-articular PRP injection with ultrasound guidance Three times PRP injections with an interval of one week |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hip pain VAS > 4
- Grade 1 and 2 osteoarthritis according to the Kellgren-Lawrence classification
- No pathologies in the laboratory and coagulation parameters
Key exclusion criteria (10 listed)
- Rheumatological disease with hip involvement
- Systemic active infection
- Severe cardiovascular disease
- Malignancy
- NSAID usage in the last week
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 |
|---|---|---|
| intra-articular PRP injection | Other | PRP injection group |
Primary outcome
Change from baseline Visual Analog Scale (VAS) score at 1-month, 3-month and 6-month
Time frame: Baseline, 1st month, 3rd month, 6th month
The VAS is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 'no pain' and 'worst pain'.
Change from baseline Western Ontario and McMaster University Osteoarthritis Index (WOMAC) score at 1-month, 3-month and 6-month
Time frame: Baseline, 1st month, 3rd month, 6th month
The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score, however there are other methods that have been used to combine scores. Higher scores: worse pain, stiffness, and functional limitations.
Change from baseline SF-36 score at 1-month, 3-month and 6-month
Time frame: Baseline, 1st month, 3rd month, 6th month
The SF-36 is a 36-item self-report measure of health-related quality of life. It has eight subscales measuring different domains of health-related quality of life: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health . Two component scores are derived from the eight subscales: a physical health component score and a mental health component score. High scores: good quality of life
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 29 Mar 2021.
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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.
Jülide Öncü Alptekin study chair
Şişli Hamidiye Etfal Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intra-articular PRP injection in people with Hip Osteoarthritis, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 10 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 29 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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.
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?
Change from baseline Visual Analog Scale (VAS) score at 1-month, 3-month and 6-month (time frame: Baseline, 1st month, 3rd month, 6th month). 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 29 Mar 2021.