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

ArthroBiologix

Status and phase: Active, not recruiting; Phase 4

Conditions: Osteoarthritis, Knee

Treatments: Biological: Platelet-rich plasma (PRP); Behavioral: Viewing of preparation

Study type: Interventional

Funder types: Industry

Identifiers

NCT04111718

ABx-prp-001

Details and patient eligibility

About

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.

Enrollment: 158 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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158 participants in 2 patient groups

Viewing of preparation

Experimental group

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.

Treatment:

Behavioral: Viewing of preparation

Biological: Platelet-rich plasma (PRP)

Blinded to preparation

Sham Comparator group

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.

Treatment:

Biological: Platelet-rich plasma (PRP)