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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04111718
Recruitment Status : Recruiting
First Posted : October 1, 2019
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
ArthroBiologix Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Biological: Platelet-rich plasma (PRP) Behavioral: Viewing of preparation Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The Impact of Procedural Awareness of Knee Injections for Osteoarthritis on Patient Perceptions of Effectiveness
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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.




Primary Outcome Measures :
  1. VAS Pain [ Time Frame: 12 weeks ]
    Visual analog scale pain on a 0-10 scale, with higher scores indicating worse pain.


Secondary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04111718


Contacts
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Contact: Steven Phillips, MSc 289-337-5717 steve.phillips@myorthoevidence.com

Locations
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Canada, Ontario
ArthroBiologix Recruiting
Hamilton, Ontario, Canada
Contact: Alexander Rabinovich, FRCSC    289-389-8181      
Sponsors and Collaborators
ArthroBiologix Inc.
Investigators
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Principal Investigator: Moin Khan, FRCSC McMaster University
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Responsible Party: ArthroBiologix Inc.
ClinicalTrials.gov Identifier: NCT04111718    
Other Study ID Numbers: ABx-prp-001
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020

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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
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases