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

Primary Purpose

Arthritis Shoulder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Glenohumeral Injection
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis Shoulder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Corticosteroid Injection Group

    Platelet-Rich Plasma Injection Group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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)

    Secondary Outcome Measures

    Full Information

    First Posted
    December 11, 2020
    Last Updated
    January 17, 2023
    Sponsor
    Rush University Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04949087
    Brief Title
    Efficacy of Intra-articular Injections for the Treatment of Primary Glenohumeral Osteoarthritis(GHOA)
    Acronym
    GHOA
    Official Title
    Prospective, Double Blind, Randomized Control Trial Comparing the Efficacy of Intra-articular Injections for the Treatment of Primary Glenohumeral Osteoarthritis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2023 (Anticipated)
    Primary Completion Date
    January 2025 (Anticipated)
    Study Completion Date
    January 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Rush University Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Arthritis Shoulder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Masking Description
    Double-blinded, randomized
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Corticosteroid Injection Group
    Arm Type
    Experimental
    Arm Description
    80mg Depo-Medrol and 8cc Lidocaine ultrasound-guided intra-articular injection
    Arm Title
    Platelet-Rich Plasma Injection Group
    Arm Type
    Active Comparator
    Arm Description
    15cc blood draw in Arthrex Autologous Conditioned Plasma (ACP) kit and processed per manufacturer instructions Ultrasound-guided intra-articular injection of isolated PRP
    Intervention Type
    Procedure
    Intervention Name(s)
    Glenohumeral Injection
    Intervention Description
    Patients who enroll will be randomized into an injection group, and then will undergo the specified injection at one time point only.
    Primary Outcome Measure Information:
    Title
    Visual Analog Scale-Pain (VAS)
    Description
    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)
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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