Platelet Rich Plasma for Musculoskeletal Conditions

NCT ID: NCT07231471

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-15
• Study Completion Date: 2035-01-01

Brief Summary

The primary purpose of this study is to follow patients with various musculoskeletal (MSK) conditions over a one-year follow-up period after receiving a platelet rich plasma (PRP) injection, assessing changes in their pain levels, functional abilities, and overall patient satisfaction.

This will develop a robust registry of patients treated with PRP for a range of MSK conditions. These conditions include, but are not limited to, osteoarthritis (OA) of the knee, hip, glenohumeral joint, elbow, ankle, and sacroiliac joint, as well as rotator cuff tendinopathy, lateral and medial epicondylitis, plantar fasciitis, patellar tendinopathy, Achilles tendinopathy, and proximal hamstring tendinopathy.

Detailed Description

Platelet-Rich Plasma (PRP) is an injectable preparation of a patient's blood that can be used for numerous conditions and has received significant attention over the past several years for its potential application for the treatment of pain and functional impairment due to osteoarthritis (OA) and other musculoskeletal conditions. Research on PRP has expanded dramatically over the last several decades, elevating its status from snake oil to a proven injection option superior to corticosteroids. It has demonstrated superior efficacy to standard-of-care corticosteroids in numerous musculoskeletal conditions. Systematic reviews of randomized-controlled trials have demonstrated equivalent-to-superior treatment outcomes associated with the use of intra-articular PRP compared to placebo, hyaluronic acid, and corticosteroid for the most commonly-studied condition, knee OA. Most importantly, just as corticosteroids have been used in numerous musculoskeletal conditions (OA, tendinopathy, bursitis, etc.), PRP has the same potential, but with vastly reduced risk; corticosteroids have many known dangers. To summarize, PRP has demonstrated level 1 evidence of superiority to corticosteroids in pain and function in numerous musculoskeletal conditions, with considerably less risk.

This study will evaluate pain, function, and overall patient satisfaction outcomes for the use of PRP for the treatment of a diverse MSK conditions, including, but not limited to, OA of the knee, hip, glenohumeral joint, elbow, ankle, and sacroiliac joint, as well as rotator cuff tendinopathy, lateral and medial epicondylitis, plantar fasciitis, patellar tendinopathy, Achilles tendinopathy, and proximal hamstring tendinopathy.

Conditions

Osteoarthritis (OA); Osteoarthritis (OA) of the Knee; Osteoarthritis (OA) of the Hip; Osteoarthritis (OA) of the Shoulder; Osteoarthritis Ankle; Elbow Osteoarthritis; Epicondylitis of the Elbow; Plantar Fasciitis of Both Feet; Tendinopathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Platelet Rich Plasma Injection

Participants who are eligible and provide consent to participate will undergo a Platelet-Rich Plasma (PRP) injection. Their whole blood and the produced PRP will be analyzed using a cell counter, and they will be asked to complete follow-up surveys at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months..

Group Type: EXPERIMENTAL

Platelet Rich Plasma Injection

Intervention Type: BIOLOGICAL

Participants who are eligible and provide consent to participate will undergo a Platelet-Rich Plasma (PRP) injection. Their blood will be analyzed using a cell counter, and they will be asked to complete follow-up surveys at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months.

Platelet Rich Plasma Preparation

Intervention Type: DEVICE

The patient's blood is collected into syringes. That blood is spun in a centrifuge at high speeds, which separates their blood into layers (red blood cells, white blood cells, and plasma). The plasma portion, which contains the platelets, is transferred to a different syringe for later injection. In some cases, the plasma is spun in the centrifuge again (a "double spin" technique) to further concentrate the platelets in the plasma. The patient's blood is not exposed to air, and it is transferred by tubing between syringes with a Luer Lock connection.

Interventions

Platelet Rich Plasma Injection

Participants who are eligible and provide consent to participate will undergo a Platelet-Rich Plasma (PRP) injection. Their blood will be analyzed using a cell counter, and they will be asked to complete follow-up surveys at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months.

Intervention Type: BIOLOGICAL

Platelet Rich Plasma Preparation

The patient's blood is collected into syringes. That blood is spun in a centrifuge at high speeds, which separates their blood into layers (red blood cells, white blood cells, and plasma). The plasma portion, which contains the platelets, is transferred to a different syringe for later injection. In some cases, the plasma is spun in the centrifuge again (a "double spin" technique) to further concentrate the platelets in the plasma. The patient's blood is not exposed to air, and it is transferred by tubing between syringes with a Luer Lock connection.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 18+ years old
• Musculoskeletal pathology that may benefit from a PRP injection
• Failed other conservative treatments

Exclusion Criteria

• No active malignancy
• No active infection in the area of injection
• No platelet disorder
• No active systemic infections
• No patients currently undergoing dialysis

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Daniel Cushman

Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Utah Orthoaedic Center

Salt Lake City, Utah, United States

Countries

United States

Central Contacts

Luke A Johnson, BS

Role: CONTACT

luke.a.johnson@hsc.utah.edu

18012133379

Jamie Egbert, MS

Role: CONTACT

jamie.egbert@utah.edu

Facility Contacts

Luke Johnson, BS

Role: primary

luke.a.johnson@hsc.utah.edu

8012133379

References

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Reference Type: BACKGROUND

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Other Identifiers

00191115

Identifier Type: -

Identifier Source: org_study_id