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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-13

Study Completion Date

2027-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Platelet-rich Plasma vs. Hyaluronic Acid for Glenohumeral Osteoarthritis

NCT02984228

Osteoarthritis Shoulder Pain

COMPLETED PHASE4

A Study Evaluating the Safety and Efficacy of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis

NCT03122860

Knee Osteoarthritis

COMPLETED PHASE2

A Study Evaluating the Safety, Tolerability, and Efficacy of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects

NCT02536833

Osteoarthritis

COMPLETED PHASE2

Osteoarthritis Shoulder Injection Study

NCT03586687

Glenohumeral Osteoarthritis

TERMINATED PHASE4

ZILRETTA in Subjects With Shoulder Osteoarthritis

NCT06269705

Glenohumeral Osteoarthritis

RECRUITING PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Arthritis Shoulder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Double-blinded, randomized

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Corticosteroid Injection Group

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

Group Type EXPERIMENTAL

Glenohumeral Injection

Intervention Type PROCEDURE

Patients who enroll will be randomized into an injection group, and then will undergo the specified injection at one time point only.

Platelet-Rich Plasma Injection Group

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

Group Type ACTIVE_COMPARATOR

Glenohumeral Injection

Intervention Type PROCEDURE

Patients who enroll will be randomized into an injection group, and then will undergo the specified injection at one time point only.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Glenohumeral Injection

Patients who enroll will be randomized into an injection group, and then will undergo the specified injection at one time point only.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No