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Completed

NCT Number: NCT04820231

Platelet-Rich Plasma and Hip Osteoarthritis

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

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Key information

Conditions

Hip Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Rheumatic Diseases

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Şişli Hamidiye Etfal Training and Research Hospital

Istanbul, Şişli, 34371, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intra-articular PRP injection

Other

Primary outcomes

  1. Change from baseline Visual Analog Scale (VAS) score at 1-month, 3-month and 6-month

    Time frame: 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'.

  2. Change from baseline Western Ontario and McMaster University Osteoarthritis Index (WOMAC) score at 1-month, 3-month and 6-month

    Time frame: 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.

  3. Change from baseline SF-36 score at 1-month, 3-month and 6-month

    Time frame: 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 life

Sponsors and collaborators

Lead sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Mar 29, 2021
Registry last updated
Mar 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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