Platelet-Rich Plasma and Hip Osteoarthritis

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.

Study Overview

• Status: Completed
• Conditions: Hip Osteoarthritis
• Intervention / Treatment: Other: intra-articular PRP injection

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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Şişli
    • İstanbul, Şişli, Turkey, 34371
      • Sisli Hamidiye Etfal Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sisli Hamidiye Etfal Training and Research Hospital
• Investigators: Study Chair: Jülide Öncü Alptekin, Sisli Hamidiye Etfal Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: March 25, 2021
• First Posted (Actual): March 29, 2021

Study Record Updates

• Last Update Posted (Actual): March 29, 2021
• Last Update Submitted That Met QC Criteria: March 25, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: ultrasound guidance; platelet-rich plasma; hip osteoarthritis
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: 191

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No