Back to resultsThe Impact of Procedural Awareness of Knee Injections for Osteoarthritis on Patient Perceptions of Effectiveness
Primary Purpose
Osteoarthritis, Knee
Status
Unknown status
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Platelet-rich plasma (PRP)
Viewing of preparation
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee
Eligibility 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
Sites / Locations
- ArthroBiologixRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Viewing of preparation
Blinded to preparation
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
VAS Pain
Visual analog scale pain on a 0-10 scale, with higher scores indicating worse pain.
Secondary Outcome Measures
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.
Range of motion
Range of motion in the knee from full extension to full flexion.
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.
Full Information
NCT ID
NCT04111718
First Posted
September 30, 2019
Last Updated
January 13, 2021
Sponsor
ArthroBiologix Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04111718
Brief Title
The Impact of Procedural Awareness of Knee Injections for Osteoarthritis on Patient Perceptions of Effectiveness
Official Title
The Impact of Procedural Awareness of Knee Injections for Osteoarthritis on Patient Perceptions of Effectiveness
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
April 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ArthroBiologix Inc.
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
158 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Viewing of preparation
Arm Type
Experimental
Arm Description
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.
Arm Title
Blinded to preparation
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Platelet-rich plasma (PRP)
Intervention Description
Autologous platelet-rich plasma which will be derived from blood drawn from the patient.
Intervention Type
Behavioral
Intervention Name(s)
Viewing of preparation
Intervention Description
The patient will receive a description of the preparation process and will view the preparation in the centrifuge.
Primary Outcome Measure Information:
Title
VAS Pain
Description
Visual analog scale pain on a 0-10 scale, with higher scores indicating worse pain.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
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.
Time Frame
12 weeks
Title
Range of motion
Description
Range of motion in the knee from full extension to full flexion.
Time Frame
12 weeks
Title
Short Form 12 (SF-12) Functional outcome assessment
Description
Health-related quality of life measure on a scale from 0-100, where higher scores indicate better function.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steven Phillips, MSc
Phone
289-337-5717
Email
steve.phillips@myorthoevidence.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moin Khan, FRCSC
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
ArthroBiologix
City
Hamilton
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Rabinovich, FRCSC
Phone
289-389-8181
12. IPD Sharing Statement
Learn more about this trial
The Impact of Procedural Awareness of Knee Injections for Osteoarthritis on Patient Perceptions of Effectiveness
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