A Prospective, Single-blind, Randomized, Multi-Center Study Comparing Platelet Rich Plasma and Corticosteroid for Patients With Glenohumeral Osteoarthritis in the Military and Civilian Population

WRNMMC-2021-0345

Shoulder arthroplasty provides successful improvement in pain and function for the treatment of end stage osteoarthritis (OA) of the shoulder in the older patient population (Sanchez 2008, Sampson 2010, Kon 2012, Fitzpatrick 2017). However, the optimal non-operative treatment for shoulder OA in the young active duty and civilian populations has yet to be determined. Although corticosteroid injections (CSI) are a viable option with diagnostic and short-term therapeutic benefit in glenohumeral OA, steroid does little to address the underlying pathology and confers risk of adjacent tendon failure (Kon 2009, Gosens 2011, Monto 2014, Tietze 2014). Platelet-rich plasma (PRP) derived from autologous blood, however, has the potential to enhance soft tissue healing as previously observed in muscles and tendons (Sanchez 2005, Randelli 2008, Hall 2009). PRP contains growth factors purported to safely facilitate local tissue regeneration as corroborated in multiple clinical studies investigating tendinopathy (Virchenko 2006, Kesikburun 2013, Fitzpatrick 2017, Schwitzguebel 2019). PRP is a promising concept to bridge the gap between conventional non-operative measures and surgical arthroscopy or arthroplasty options in a high functioning patient population with refractory disease. However, clinical literature elucidating the effects of intra-articular leukocyte-poor PRP (LP-PRP) injections in large joint degenerative OA has been slower to emerge, lacking substantiated data due to small sample sizes and treatment variability. Therefore, high level evidence-based studies remain critical in ascertaining the therapeutic value and clinical efficacy of LP-PRP in glenohumeral OA in order to establish standard of care protocols and guide systematic implementation.

2022-09-26

2026-01-01

2026-01-01

Recruiting

Early phase I

600

Inclusion Criteria: * DEERS eligible * Male or female, aged 18 to 70 years (inclusive) * Presenting symptoms of shoulder pain caused by mild to moderate Shoulder OA as defined by Samilson Prieto criteria on a standard anterior-posterior (AP) Xray series * BMI \< 40 * Willing and able to give voluntary informed consent to participate in this investigation * Glenohumeral joint osteoarthritis that has been refractory to standard care treatments Exclusion Criteria: * Patients who have received shoulder intraarticular or subacromial injection(s) in the last 3 months * Patients who have undergone arthroscopic surgery on the study shoulder within the past year * Patients who have undergone arthroplasty on the study shoulder * Diabetes (Type 1 or II) * Inflammatory arthropathies * Fibromyalgia or chronic fatigue syndrome * Female patient who is pregnant or nursing * Patients taking narcotics * Patients with planned deployment or separation from the military within 12 months * Any other serious medical condition(s) that might preclude optimal outcome and/or interfere with participation such as intra-articular sepsis, bacteremia, fracture, joint instability, rheumatoid arthritis, osteoporosis, cancer, and coagulopathy * Patients who have had an adverse reaction to a previous corticosteroid or PRP injection either documented in the medical record or shared by the patient during screening

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2023-10-23