Platelet-Rich Plasma and Hip Osteoarthritis

NCT04820231 | Completed

• 1 other identifier: 191
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hip Osteoarthritis

Keywords

hip osteoarthritis; platelet-rich plasma; ultrasound guidance

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

PRP injection group

OTHER

Intra-articular PRP injection with ultrasound guidance Three times PRP injections with an interval of one week

Other: intra-articular PRP injection

Interventions

intra-articular PRP injection OTHER

PRP injection group

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hip pain VAS \> 4
• Grade 1 and 2 osteoarthritis according to the Kellgren-Lawrence classification
• No pathologies in the laboratory and coagulation parameters

You may not qualify if:

• 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

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Study Sites (1)

Şişli Hamidiye Etfal Training and Research Hospital

Istanbul, Şişli, 34371, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Jülide Öncü Alptekin

  Şişli Hamidiye Etfal Training and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist, Principal investigator

Model Details: The patients with mono-lateral hip pain , grade 1 or 2 hip osteoarthritis according to the Kellgren-Lawrence classification

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 29, 2021
• Study Start: January 1, 2017
• Primary Completion: July 1, 2017
• Study Completion: January 1, 2018
• Last Updated: March 29, 2021

Record last verified: 2021-03

Locations

TU (1)