The Impact of Procedural Awareness of Knee Injections for Osteoarthritis on Patient Perceptions of Effectiveness
1 other identifier
interventional
158
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2019
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2019
CompletedFirst Posted
Study publicly available on registry
October 1, 2019
CompletedStudy Start
First participant enrolled
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedSeptember 30, 2025
September 1, 2025
6.2 years
September 30, 2019
September 27, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
VAS Pain
Visual analog scale pain on a 0-10 scale, with higher scores indicating worse pain.
12 weeks
Secondary Outcomes (3)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
12 weeks
Range of motion
12 weeks
Short Form 12 (SF-12) Functional outcome assessment
12 weeks
Study Arms (2)
Viewing of preparation
EXPERIMENTALThe 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.
Blinded to preparation
SHAM COMPARATORThe 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.
Interventions
Autologous platelet-rich plasma which will be derived from blood drawn from the patient.
The patient will receive a description of the preparation process and will view the preparation in the centrifuge.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ArthroBiologix
Hamilton, Ontario, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Moin Khan, FRCSC
McMaster University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2019
First Posted
October 1, 2019
Study Start
October 1, 2019
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
September 30, 2025
Record last verified: 2025-09