Platelet-Rich Plasma and Hip Osteoarthritis
- Conditions
- Hip Osteoarthritis
- Registration Number
- NCT04820231
- Lead Sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Brief Summary
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
- Hip pain VAS > 4
- Grade 1 and 2 osteoarthritis according to the Kellgren-Lawrence classification
- No pathologies in the laboratory and coagulation parameters
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Change from baseline Visual Analog Scale (VAS) score at 1-month, 3-month and 6-month 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 SF-36 score at 1-month, 3-month and 6-month 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 lifeChange from baseline Western Ontario and McMaster University Osteoarthritis Index (WOMAC) score at 1-month, 3-month and 6-month 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Şişli Hamidiye Etfal Training and Research Hospital
🇹🇷İstanbul, Şişli, Turkey
Şişli Hamidiye Etfal Training and Research Hospital🇹🇷İstanbul, Şişli, Turkey