Osteoarthritis, KneePhase 4NCT04111718
The Impact of Procedural Awareness of Knee Injections for Osteoarthritis on Patient Perceptions of Effectiveness
A Phase 4 study testing Platelet-rich plasma (PRP) and Viewing of preparation in people with Osteoarthritis, Knee, run by ArthroBiologix Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Platelet-rich plasma (PRP) and Viewing of preparation
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2019to Dec 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Platelet-rich plasma (PRP), Viewing of preparation
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-rich plasma (PRP)Biological
Autologous platelet-rich plasma which will be derived from blood drawn from the patient.
Viewing of preparationBehavioural
The patient will receive a description of the preparation process and will view the preparation in the centrifuge.
| Study group | Role | What they receive |
|---|---|---|
| Viewing of preparation | Experimental | 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. Receives: Biological: Platelet-rich plasma (PRP); Behavioral: Viewing of preparation |
| Blinded to preparation | Sham comparator | 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. Receives: Biological: Platelet-rich plasma (PRP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS Pain
Visual analog scale pain on a 0-10 scale, with higher scores indicating worse pain.
Measured: 12 weeks
Secondary outcomes (3)
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.
Measured: 12 weeks
Range of motion
Range of motion in the knee from full extension to full flexion.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start1 Oct 2019
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ArthroBiologix Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Moin Khan, FRCSC, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04111718
- Sponsor's protocol ID
- ABx-prp-001
- Status last verified
- Sep 2025
- First submitted
- 30 Sep 2019
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Procedural Awareness of Knee Injections for Osteoarthritis on Patient Perceptions of Effectiveness
- ClinicalTrials.gov ID
- NCT04111718
- Acronym / sponsor ID
- ABx-prp-001
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- ArthroBiologix Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 1 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Viewing of preparation | Experimental | Biological: Platelet-rich plasma (PRP), Behavioral: Viewing of preparationThe 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 comparator | Biological: Platelet-rich plasma (PRP)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. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet-rich plasma (PRP)Autologous platelet-rich plasma which will be derived from blood drawn from the patient. | Biological | Blinded to preparation, Viewing of preparation |
| Viewing of preparationThe patient will receive a description of the preparation process and will view the preparation in the centrifuge. | Behavioural | Viewing of preparation |
Primary outcome
VAS Pain
Time frame: 12 weeks
Visual analog scale pain on a 0-10 scale, with higher scores indicating worse pain.
3 secondary outcomes
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 12 weeks
Range of motion
Time frame: 12 weeks
Short Form 12 (SF-12) Functional outcome assessment
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moin Khan, FRCSC principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Platelet-rich plasma (PRP) and Viewing of preparation in people with Osteoarthritis, Knee, run by ArthroBiologix Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS Pain (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.