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

September 27, 2025 updated by: ArthroBiologix Inc.
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

158

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada
        • ArthroBiologix

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Viewing of preparation
The patient will be in the room for the preparation of the PRP and will receive a description of the centrifuge process from the physician administering the injection.
Biological: Platelet-rich plasma (PRP)
Autologous platelet-rich plasma which will be derived from blood drawn from the patient.
Behavioral: Viewing of preparation
The patient will receive a description of the preparation process and will view the preparation in the centrifuge.
Sham Comparator: Blinded to preparation
The patient will leave the room after their blood is drawn and will not view the preparation of the PRP, and will also not receive a description of the centrifuge process.
Biological: Platelet-rich plasma (PRP)
Autologous platelet-rich plasma which will be derived from blood drawn from the patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS Pain
Time Frame: 12 weeks
Visual analog scale pain on a 0-10 scale, with higher scores indicating worse pain.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks
Range of motion
Time Frame: 12 weeks
Range of motion in the knee from full extension to full flexion.
12 weeks
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ArthroBiologix Inc.

Investigators

  • Principal Investigator: Moin Khan, FRCSC, McMaster University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

September 30, 2019

First Submitted That Met QC Criteria

September 30, 2019

First Posted (Actual)

October 1, 2019

Study Record Updates

Last Update Posted (Estimated)

September 30, 2025

Last Update Submitted That Met QC Criteria

September 27, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABx-prp-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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