Efficacy of Intra-articular Injections for the Treatment of Primary Glenohumeral Osteoarthritis(GHOA)

Rush

Status: Enrolling

Conditions: Arthritis Shoulder

Treatments: Procedure: Glenohumeral Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04949087

ORA 18060603

Details and patient eligibility

About

The purpose of this study is to compare the efficacy of intra-articular corticosteroid injections versus platelet-rich plasma injections for non-operative treatment of primary glenohumeral osteoarthritis. The efficacy of intra-articular injections, outside of hyaluronic acid, for the treatment of glenohumeral OA is not known, yet these treatments are commonly used with hopes of providing patients with symptomatic relief that can hopefully delay or prevent the need for shoulder arthroplasty. This study will help elucidate the therapeutic benefit of corticosteroid and Platelet Rich Plasma (PRP) injections in this patient population.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient ≥18y.o. of age
• Primary glenohumeral arthritis (bone on bone or near bone on bone) that has been previously diagnosed on radiographs and clinical evaluation.
• Baseline pain level of VAS >4

Exclusion criteria

• Secondary causes of arthritis (i.e. septic arthritis, rheumatoid arthritis, rotator cuff arthropathy, post-traumatic arthritis)
• Ipsilateral shoulder surgery within 1 year
• Any glenohumeral joint injection within 3 months
• Allergy to lidocaine
• Known pregnancy
• Workers compensation case regarding shoulder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups

Corticosteroid Injection Group

Experimental group

Description:

80mg Depo-Medrol and 8cc Lidocaine ultrasound-guided intra-articular injection

Treatment:

Procedure: Glenohumeral Injection

Platelet-Rich Plasma Injection Group

Active Comparator group

Description:

15cc blood draw in Arthrex Autologous Conditioned Plasma (ACP) kit and processed per manufacturer instructions Ultrasound-guided intra-articular injection of isolated PRP

Treatment:

Procedure: Glenohumeral Injection