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

NCT ID: NCT04111718

Last Updated: 2025-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Platelet-rich plasma (PRP)

Intervention Type BIOLOGICAL

Autologous platelet-rich plasma which will be derived from blood drawn from the patient.

Viewing of preparation

Intervention Type BEHAVIORAL

The patient will receive a description of the preparation process and will view the preparation in the centrifuge.

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.

Group Type SHAM_COMPARATOR

Platelet-rich plasma (PRP)

Intervention Type BIOLOGICAL

Autologous platelet-rich plasma which will be derived from blood drawn from the patient.

Interventions

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Platelet-rich plasma (PRP)

Autologous platelet-rich plasma which will be derived from blood drawn from the patient.

Intervention Type BIOLOGICAL

Viewing of preparation

The patient will receive a description of the preparation process and will view the preparation in the centrifuge.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ArthroBiologix Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Moin Khan, FRCSC

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

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ArthroBiologix

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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ABx-prp-001

Identifier Type: -

Identifier Source: org_study_id

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