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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04949087
Other study ID # ORA 18060603
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 13, 2023
Est. completion date January 2026

Study information

Verified date October 2023
Source Rush University Medical Center
Contact Carla M Edwards, PhD
Phone 312.563.5735
Email carla_edwards@rush.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date January 2026
Est. primary completion date January 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Rush University Medical Center Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analog Scale-Pain (VAS) Validated patient-reported metric scale of pain: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm) 12 weeks
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