PRP for Glenohumeral Osteoarthritis

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Primary Purpose

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Low-dose PRP

High-dose PRP

Saline

About this trial

This is an interventional treatment trial for Shoulder Osteoarthritis

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 18-100 years old Average NRS pain greater than or equal to 5/10 as a direct result of glenohumeral osteoarthritis (any severity: mild, moderate, or severe) and/or chondral lesion or loss At least 3 months of pain after onset of symptoms that has failed conservative treatments, including physical therapy MRI of the affected joint Transient relief of symptoms after a diagnostic intra-articular injection into the joint Email address or network access Exclusion Criteria: Inability to hold non-steroidal anti-inflammatory drugs for 2 weeks prior and 1 month after the injection Prior platelet-rich plasma injection Steroid injection within 3 months of the initial injection Hyaluronic acid within 6 months of the initial injection Involved in workers' compensation or active litigation involving the affected joint History of Plavix use Known uncontrolled systemic illness (uncontrolled diabetes, HIV, vasculitis, autoimmune/autoinflammatory disease) Presence of acute fractures or gross mechanical deformities Concurrent "uncontrolled" cervical disorders

Sites / Locations

Hospital for Special SurgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Low-dose PRP

High-dose PRP

Saline control

Arm Description

Patients will receive a single injection of 6 ml low-dose platelet-rich plasma (PRP) into the glenohumeral joint. Low-dose is defined as a platelet yield of 3X (i.e., 3-fold increase in platelets in PRP compared to whole blood).

Patients will receive a single injection of 6 ml high-dose platelet-rich plasma (PRP) into the glenohumeral joint. High-dose is defined as a platelet yield of 12X (i.e., 12-fold increase in platelets in PRP compared to whole blood).

Patients will receive a single injection of 6 ml saline into the glenohumeral joint.

Outcomes

Primary Outcome Measures

American Shoulder and Elbow Surgeons (ASES) Shoulder Score

The ASES measures pain and function in activities of daily living related to the shoulder. On a 100-point scale, a higher score represents less pain/higher function.

Secondary Outcome Measures

Average numerical rating scale (NRS) pain score

Average NRS pain during the past week. This is on a scale of 0-10, with 0 representing no pain and 10 representing the worst pain possible.

Patient-Reported Outcomes Measurement Information System (PROMIS)-10 Global Health measure

The PROMIS-10 assesses physical health and mental health. A higher score represents better physical health and mental health.

PROMIS-Upper Extremity computer adaptive test (CAT)

The PROMIS-Upper Extremity CAT measures upper extremity (shoulder) function. A higher scores represents better function.

Medication use

Patients will be asked if they are using any of the following medications: non-steroidal anti-inflammatory drugs, opioids, selective serotonin reuptake inhibitors, or neuropathic medications.

PROMIS Sleep Disturbance

The PROMIS sleep disturbance measures sleep impairment/disturbance. A higher score represents more sleep disturbance (e.g., worse sleep quality).

Patient satisfaction

Patient satisfaction is assessed on a 0-10 scale, with 0 meaning "not satisfied at all" and 10 meaning "very satisfied".

Full Information

NCT ID

NCT05675527

First Posted

December 28, 2022

Last Updated

May 4, 2023

Sponsor

Hospital for Special Surgery, New York

1. Study Identification

Unique Protocol Identification Number

NCT05675527

Brief Title

PRP for Glenohumeral Osteoarthritis

Official Title

Outcomes Following Single Injections of Low-dose Platelet-rich Plasma (PRP), High-dose PRP, or Saline in Patients With Glenohumeral OA: a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 2, 2023 (Actual)

Primary Completion Date

May 1, 2024 (Anticipated)

Study Completion Date

February 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospital for Special Surgery, New York

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief Summary

The glenohumeral joint is the third most common large joint to be affected by OA. Conservative treatments include physical activity, corticosteroid injections, and medications. PRP is an emerging treatment that has shown efficacy in different musculoskeletal conditions. The use of PRP for glenohumeral OA has been described sparingly in the literature but has shown efficacy in a couple studies and case reports. However, all of the previous studies investigating PRP for glenohumeral OA have focused on low-dose PRP preparations (~3X), and none have compared PRP treatment to saline treatment. This study aims to compare outcomes following single injections of low-dose PRP, high-dose PRP, or saline in patients with glenohumeral osteoarthritis.

6. Conditions and Keywords

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

Shoulder Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

135 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Low-dose PRP

Arm Type

Experimental

Arm Description

Patients will receive a single injection of 6 ml low-dose platelet-rich plasma (PRP) into the glenohumeral joint. Low-dose is defined as a platelet yield of 3X (i.e., 3-fold increase in platelets in PRP compared to whole blood).

Arm Title

High-dose PRP

Arm Type

Experimental

Arm Description

Patients will receive a single injection of 6 ml high-dose platelet-rich plasma (PRP) into the glenohumeral joint. High-dose is defined as a platelet yield of 12X (i.e., 12-fold increase in platelets in PRP compared to whole blood).

Arm Title

Saline control

Arm Type

Placebo Comparator

Arm Description

Patients will receive a single injection of 6 ml saline into the glenohumeral joint.

Intervention Type

Biological

Intervention Name(s)

Low-dose PRP

Intervention Description

Injection

Intervention Type

Biological

Intervention Name(s)

High-dose PRP

Intervention Description

Injection

Intervention Type

Other

Intervention Name(s)

Saline

Intervention Description

Injection

Primary Outcome Measure Information:

Title

American Shoulder and Elbow Surgeons (ASES) Shoulder Score

Description

The ASES measures pain and function in activities of daily living related to the shoulder. On a 100-point scale, a higher score represents less pain/higher function.

Time Frame

3 months post-injection

Secondary Outcome Measure Information:

Title

Average numerical rating scale (NRS) pain score

Description

Average NRS pain during the past week. This is on a scale of 0-10, with 0 representing no pain and 10 representing the worst pain possible.

Time Frame