search
Back to results

Platelet-Rich Plasma and Hip Osteoarthritis

Primary Purpose

Hip Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
intra-articular PRP injection
Sponsored by
Sisli Hamidiye Etfal Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Osteoarthritis focused on measuring hip osteoarthritis, platelet-rich plasma, ultrasound guidance

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Şişli Hamidiye Etfal Training and Research Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

PRP injection group

Arm Description

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

Outcomes

Primary Outcome Measures

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'.
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.
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

Secondary Outcome Measures

Full Information

First Posted
March 23, 2021
Last Updated
March 25, 2021
Sponsor
Sisli Hamidiye Etfal Training and Research Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04820231
Brief Title
Platelet-Rich Plasma and Hip Osteoarthritis
Official Title
The Effect of Platelet-Rich Plasma Injection on Pain, Function and Quality of Life in Patients With Hip Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sisli Hamidiye Etfal Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis
Keywords
hip osteoarthritis, platelet-rich plasma, ultrasound guidance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRP injection group
Arm Type
Other
Arm Description
Intra-articular PRP injection with ultrasound guidance Three times PRP injections with an interval of one week
Intervention Type
Other
Intervention Name(s)
intra-articular PRP injection
Primary Outcome Measure Information:
Title
Change from baseline Visual Analog Scale (VAS) score at 1-month, 3-month and 6-month
Description
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'.
Time Frame
Baseline, 1st month, 3rd month, 6th month
Title
Change from baseline Western Ontario and McMaster University Osteoarthritis Index (WOMAC) score at 1-month, 3-month and 6-month
Description
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.
Time Frame
Baseline, 1st month, 3rd month, 6th month
Title
Change from baseline SF-36 score at 1-month, 3-month and 6-month
Description
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
Time Frame
Baseline, 1st month, 3rd month, 6th month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jülide Öncü Alptekin
Organizational Affiliation
Şişli Hamidiye Etfal Training and Research Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Şişli Hamidiye Etfal Training and Research Hospital
City
İstanbul
State/Province
Şişli
ZIP/Postal Code
34371
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

Platelet-Rich Plasma and Hip Osteoarthritis

We'll reach out to this number within 24 hrs