Clinical trial NCT05675527: PRP for Glenohumeral Osteoarthritis
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Shoulder Osteoarthritis
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2023-01-09
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: American Shoulder and Elbow Surgeons (ASES) Shoulder Score
timeFrame: 3 months post-injection
Secondary outcomes:
measure: Average numerical rating scale (NRS) pain score
timeFrame: Up to 12 months post-injection
measure: Patient-Reported Outcomes Measurement Information System (PROMIS)-10 Global Health measure
timeFrame: Up to 12 months post-injection
measure: PROMIS-Upper Extremity computer adaptive test (CAT)
timeFrame: Up to 12 months post-injection
measure: Medication use
timeFrame: Up to 12 months post-injection
measure: PROMIS Sleep Disturbance
timeFrame: Up to 12 months post-injection
measure: Patient satisfaction
timeFrame: Up to 12 months post-injection
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
References: