Platelet-Rich Plasma and Hip Osteoarthritis

Hip Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04820231
• Other study ID #: 191
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: January 2018

Study information

• Verified date: March 2021
• Source: Sisli Hamidiye Etfal Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Other:
• intra-articular PRP injection

Locations

Country	Name	City	State
Turkey	Sisli Hamidiye Etfal Training and Research Hospital	Istanbul	Sisli

Sponsors (1)

Lead Sponsor	Collaborator
Sisli Hamidiye Etfal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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