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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04111718
• Other study ID #: ABx-prp-001
• Status: Recruiting
• Phase: Phase 4
• Start date: October 1, 2019
• Est. completion date: April 2022

Study information

• Verified date: January 2021
• Source: ArthroBiologix Inc.
• Contact: Steven Phillips, MSc
• Phone: 289-337-5717
• Email: steve.phillips[@]myorthoevidence.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 158
• Est. completion date: April 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Biological:
• Platelet-rich plasma (PRP)
Autologous platelet-rich plasma which will be derived from blood drawn from the patient.

Behavioral:
• Viewing of preparation
The patient will receive a description of the preparation process and will view the preparation in the centrifuge.

Locations

Country	Name	City	State
Canada	ArthroBiologix	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
ArthroBiologix Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS Pain	Visual analog scale pain on a 0-10 scale, with higher scores indicating worse pain.	12 weeks
Secondary	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.	12 weeks
Secondary	Range of motion	Range of motion in the knee from full extension to full flexion.	12 weeks
Secondary	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.	12 weeks