Platelet-Rich Plasma and Hip Osteoarthritis

Study Overview
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Brief Summary
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To evaluate the effect of platelet-rich plasma (PRP) injection on pain, function and quality of life in patients with hip osteoarthritis.

Detailed Description
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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

Official Title
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The Effect of Platelet-Rich Plasma Injection on Pain, Function and Quality of Life in Patients With Hip Osteoarthritis

Conditions
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Hip Osteoarthritis

Intervention / Treatment
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* Other: intra-articular PRP injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hip pain VAS > 4 Grade 1 and 2 osteoarthritis according to the Kellgren-Lawrence classification No pathologies in the laboratory and coagulation parameters Exclusion Criteria: Rheumatological disease with hip involvement Systemic active infection Severe cardiovascular disease Malignancy NSAID usage in the last week History of hip joint surgery History of traumatic hip injury Hgb values < 11 gr/dl Platelets values < 150.000 / µl History of bleeding disorder

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PRP injection group<br>Intra-articular PRP injection with ultrasound guidance Three times PRP injections with an interval of one week | Other: intra-articular PRP injection<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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'. | 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. | 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 | Baseline, 1st month, 3rd month, 6th month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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platelet-rich plasma, ultrasound guidance, hip osteoarthritis