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NCT Number: NCT04111718

The Impact of Procedural Awareness of Knee Injections for Osteoarthritis on Patient Perceptions of Effectiveness

The purpose of this study is to determine whether outcomes for patients receiving intra-articular platelet-rich plasma (PRP) injections for knee osteoarthritis are influenced by observation of the preparatory steps to the procedure. The viewing of the steps involved in the administration of PRP may increase the effectiveness of the treatment in comparison to patients who have not observed the preparatory steps.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

ArthroBiologix

Hamilton, Ontario, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult men or women ages 50-80 years
  • Diagnosis of symptomatic osteoarthritis of the knee based on clinical and radiographic criteria
  • Provision of informed consent

Exclusion criteria

  • Patients with inflammatory osteoarthritis
  • Open wounds or sores over the knee joint
  • Patients that will likely have problems, in the judgement of the investigators, with maintaining follow-up

Treatment and study plan

Platelet-Rich Plasma (PRP)

Biological

Autologous platelet-rich plasma which will be derived from blood drawn from the patient.

Viewing of preparation

Behavioral

The patient will receive a description of the preparation process and will view the preparation in the centrifuge.

Primary outcomes

  1. VAS Pain

    Time frame: 12 weeks

    Visual analog scale pain on a 0-10 scale, with higher scores indicating worse pain.

Secondary outcomes

  1. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: 12 weeks

    Patient reported knee osteoarthritis index with subscores of pain, function and stiffness. The range of scores on the WOMAC is from 0-96, with higher scores indicating worse outcomes. The subscore of pain is on a scale of 0-20, the subscore of stiffness is 0-8, and the subscale of function is 0-68. The scores of the subscales are summed in order to get the total score.

  2. Range of motion

    Time frame: 12 weeks

    Range of motion in the knee from full extension to full flexion.

  3. Short Form 12 (SF-12) Functional outcome assessment

    Time frame: 12 weeks

    Health-related quality of life measure on a scale from 0-100, where higher scores indicate better function.

Sponsors and collaborators

Lead sponsor

ArthroBiologix Inc.

Industry

Registry information

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Oct 1, 2019
Registry last updated
Sep 30, 2025

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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