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.

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Biological: Platelet-rich plasma (PRP); Behavioral: Viewing of preparation

• Study Type: Interventional
• Enrollment (Anticipated): 158
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Steven Phillips, MSc; Phone Number: 289-337-5717; Email: steve.phillips@myorthoevidence.com

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada
      • Recruiting
      • ArthroBiologix
      • Contact: Alexander Rabinovich, FRCSC; Phone Number: 289-389-8181

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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)	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	Range of motion in the knee from full extension to full flexion.	12 weeks
Short Form 12 (SF-12) Functional outcome assessment	Health-related quality of life measure on a scale from 0-100, where higher scores indicate better function.	12 weeks

Collaborators and Investigators

• Sponsor: ArthroBiologix Inc.
• Investigators: Principal Investigator: Moin Khan, FRCSC, McMaster University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): April 1, 2022

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 (Actual): January 14, 2021
• Last Update Submitted That Met QC Criteria: January 13, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• 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