PRP for Glenohumeral Osteoarthritis

Hospital for Special Surgery (HSS)

Status and phase: Enrolling; Phase 4

Conditions: Shoulder Osteoarthritis

Treatments: Biological: Low-dose PRP; Other: Saline; Biological: High-dose PRP

Study type: Interventional

Funder types: Other

Identifiers

NCT05675527

2022-0720

Details and patient eligibility

About

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.

Enrollment: 135 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Inability to hold non-steroidal anti-inflammatory drugs for 2 weeks prior and 1 month after the injection
• Prior platelet-rich plasma injection
• Steroid injection within 3 months of the initial injection
• Hyaluronic acid within 6 months of the initial injection
• Involved in workers' compensation or active litigation involving the affected joint
• History of Plavix use
• Known uncontrolled systemic illness (uncontrolled diabetes, HIV, vasculitis, autoimmune/autoinflammatory disease)
• Presence of acute fractures or gross mechanical deformities
• Concurrent "uncontrolled" cervical disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

135 participants in 3 patient groups, including a placebo group

Low-dose PRP

Experimental group

Description:

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).

Treatment:

Biological: Low-dose PRP

High-dose PRP

Experimental group

Description:

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).

Treatment:

Biological: High-dose PRP

Saline control

Placebo Comparator group

Description:

Patients will receive a single injection of 6 ml saline into the glenohumeral joint.

Treatment:

Other: Saline