Outcomes Following Single Injections of Low-dose Platelet-rich Plasma (PRP), High-dose PRP, or Saline in Patients With Glenohumeral OA: a Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Biological, Other
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The glenohumeral joint is the third most common large joint to be affected by OA. Conservative treatments include physical activity, corticosteroid injections, and medications. PRP is an emerging treatment that has shown efficacy in different musculoskeletal conditions. The use of PRP for glenohumeral OA has been described sparingly in the literature but has shown efficacy in a couple studies and case reports. However, all of the previous studies investigating PRP for glenohumeral OA have focused on low-dose PRP preparations (\ 3X), and none have compared PRP treatment to saline treatment. This study aims to compare outcomes following single injections of low-dose PRP, high-dose PRP, or saline in patients with glenohumeral osteoarthritis.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 18-100 years old

• Average NRS pain greater than or equal to 5/10 as a direct result of glenohumeral osteoarthritis (any severity: mild, moderate, or severe) and/or chondral lesion or loss

• At least 3 months of pain after onset of symptoms that has failed conservative treatments, including physical therapy

• MRI of the affected joint

• Transient relief of symptoms after a diagnostic intra-articular injection into the joint

• Email address or network access

Locations
United States
New York
Hospital for Special Surgery
RECRUITING
New York
Contact Information
Primary
Jonathan Kirschner, MD
kirschnerj@hss.edu
646-714-6327
Backup
Jennifer Cheng
chengj@hss.edu
646-714-6870
Time Frame
Start Date: 2023-05-02
Estimated Completion Date: 2026-09-01
Participants
Target number of participants: 135
Treatments
Experimental: Low-dose PRP
Patients will receive a single injection of 6 ml low-dose platelet-rich plasma (PRP) into the glenohumeral joint. Low-dose is defined as a platelet yield of 3X (i.e., 3-fold increase in platelets in PRP compared to whole blood).
Experimental: High-dose PRP
Patients will receive a single injection of 6 ml high-dose platelet-rich plasma (PRP) into the glenohumeral joint. High-dose is defined as a platelet yield of 12X (i.e., 12-fold increase in platelets in PRP compared to whole blood).
Placebo_comparator: Saline control
Patients will receive a single injection of 6 ml saline into the glenohumeral joint.
Related Therapeutic Areas
Sponsors
Leads: Hospital for Special Surgery, New York

This content was sourced from clinicaltrials.gov