MedPath

PRP for Glenohumeral Osteoarthritis

Phase 4
Recruiting
Conditions
Shoulder Osteoarthritis
Interventions
Biological: Low-dose PRP
Other: Saline
Biological: High-dose PRP
Registration Number
NCT05675527
Lead Sponsor
Hospital for Special Surgery, New York
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
135
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Low-dose PRPLow-dose PRPPatients 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).
Saline controlSalinePatients will receive a single injection of 6 ml saline into the glenohumeral joint.
High-dose PRPHigh-dose PRPPatients 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).
Primary Outcome Measures
NameTimeMethod
American Shoulder and Elbow Surgeons (ASES) Shoulder Score3 months post-injection

The ASES measures pain and function in activities of daily living related to the shoulder. On a 100-point scale, a higher score represents less pain/higher function.

Secondary Outcome Measures
NameTimeMethod
PROMIS-Upper Extremity computer adaptive test (CAT)Up to 12 months post-injection

The PROMIS-Upper Extremity CAT measures upper extremity (shoulder) function. A higher scores represents better function.

Medication useUp to 12 months post-injection

Patients will be asked if they are using any of the following medications: non-steroidal anti-inflammatory drugs, opioids, selective serotonin reuptake inhibitors, or neuropathic medications.

Average numerical rating scale (NRS) pain scoreUp to 12 months post-injection

Average NRS pain during the past week. This is on a scale of 0-10, with 0 representing no pain and 10 representing the worst pain possible.

Patient-Reported Outcomes Measurement Information System (PROMIS)-10 Global Health measureUp to 12 months post-injection

The PROMIS-10 assesses physical health and mental health. A higher score represents better physical health and mental health.

PROMIS Sleep DisturbanceUp to 12 months post-injection

The PROMIS sleep disturbance measures sleep impairment/disturbance. A higher score represents more sleep disturbance (e.g., worse sleep quality).

Patient satisfactionUp to 12 months post-injection

Patient satisfaction is assessed on a 0-10 scale, with 0 meaning "not satisfied at all" and 10 meaning "very satisfied".

Trial Locations

Locations (1)

Hospital for Special Surgery

🇺🇸

New York, New York, United States

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