Comparing Platelet Rich Plasma and Corticosteroid for Military & Civilian Patients With Glenohumeral Osteoarthritis

NCT ID: NCT05160441

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-26
• Study Completion Date: 2025-05-08

Brief Summary

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.

Detailed Description

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.

Although commonly used corticosteroid injections have shown some clinical benefit, there are known deleterious effects from steroid use, which include accelerated osteoarthritis progression, cartilage toxicity, and increased risk of septic arthritis. In addition to this, multiple studies demonstrate corticosteroids confers risk of adjacent tendon failure (Kon 2009, Gosens 2011, Monto 2014, Tietze 2014). There is also a concern that multiple corticosteroid injections increase the risk of fat atrophy, skin pigment changes, and tissue thinning if placed incorrectly in the more superficial tissue of the shoulder. These negative findings associated with corticosteroid injections have prompted ongoing research into alternative orthobiologic treatments that provide short to medium duration benefit for patients with osteoarthritis.

Conversely, Leukocyte-Poor Platelet-Rich Plasma (LP-PRP), derived from autologous blood, has demonstrated safety and efficacy in multiple pre-clinical, randomized controlled clinical trials, and meta-analysis studies in the other large joints, causing slow acceptance in the medical community to utilize this as a treatment option, despite its increased cost compared to corticosteroid injection (Campbell 2015, Cavallo 2014, Lai 2015, Laudy 2015, Patel 2013, Smith 2016, Tietze 2014, Piuzzi 2019). However, clinical literature elucidating the effects of intraarticular leukocyte-poor PRP (LP-PRP) injections in shoulder 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. 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.

Conditions

Osteoarthritis of the Shoulder; Corticosteroid; PRP; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Platelet Rich Plasma Injection Group

Minimum 2cc Leukocyte Poor Platelet Rich Plasma

Group Type: EXPERIMENTAL

Platelet Rich Plasma Injection

Intervention Type: BIOLOGICAL

Minimum 2cc Leukocyte Poor Platelet Rich Plasma

The PRP will be prepared by drawing 60cc blood from the participant through venipuncture, spinning the blood sample in a centrifuge and then injecting the platelet rich plasma (approximately 2-5cc or max collected) into the study shoulder using ultrasound guidance. This sample will be prepared by the study provider (physician assistant or physician). Any leftover blood will be safely discarded per standard protocols.

Corticosteroid Injection Group

5cc Normal Saline + 2cc 10 mg/ml Triamcinolone Acetonide (Kenalog)

Group Type: ACTIVE_COMPARATOR

Corticosteroid Injection

Intervention Type: BIOLOGICAL

5cc Normal Saline + 2cc 10 mg/ml Triamcinolone Acetonide (Kenalog)

Delayed Platelet Rich Plasma Injection Group upon Corticosteroid Injection Failure

If a participant does not have any benefit from the corticosteroid injection by the six-week follow-up time point, then that participant will be eligible for a platelet rich plasma injection.

Group Type: EXPERIMENTAL

Delayed Platelet Rich Plasma Injection After Corticosteroid Injection Failure

Intervention Type: BIOLOGICAL

Participants randomized to the corticosteroid injection (CSI) group who report no improvement in their pain level at the 6 week post-CSI visit will be unblinded to their study injection (CSI) and will be offered the option to stay in the study and receive Platelet Rich Plasma injection.

Interventions

Platelet Rich Plasma Injection

Minimum 2cc Leukocyte Poor Platelet Rich Plasma

The PRP will be prepared by drawing 60cc blood from the participant through venipuncture, spinning the blood sample in a centrifuge and then injecting the platelet rich plasma (approximately 2-5cc or max collected) into the study shoulder using ultrasound guidance. This sample will be prepared by the study provider (physician assistant or physician). Any leftover blood will be safely discarded per standard protocols.

Intervention Type: BIOLOGICAL

Corticosteroid Injection

5cc Normal Saline + 2cc 10 mg/ml Triamcinolone Acetonide (Kenalog)

Intervention Type: BIOLOGICAL

Delayed Platelet Rich Plasma Injection After Corticosteroid Injection Failure

Participants randomized to the corticosteroid injection (CSI) group who report no improvement in their pain level at the 6 week post-CSI visit will be unblinded to their study injection (CSI) and will be offered the option to stay in the study and receive Platelet Rich Plasma injection.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Naval Medical Center, San Diego

FED

Sponsor Role: collaborator

Brooke Army Medical Center

FED

Sponsor Role: collaborator

Uniformed Services University of the Health Sciences

FED

Sponsor Role: collaborator

Walter Reed National Military Medical Center

FED

Sponsor Role: lead

Responsible Party

Sean Slaven

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Countries

United States

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Provided Documents

Document Type: Informed Consent Form

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Other Identifiers

WRNMMC-2021-0345

Identifier Type: -

Identifier Source: org_study_id