Rotator Cuff TearsNCT06481046
Treatment of Rotator Cuff Tears With Platelet Rich Plasma
A study testing Platelet Rich Plasma (PRP) in people with Rotator Cuff Tears and Rotator Cuff Tendinitis, run by The Foundation for Orthopaedics and Regenerative Medicine at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of dual platelet rich plasma (PRP) injections into the rotator cuff insertion and the area of the tendon proximal to the insertion. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Rotator Cuff Tears, Rotator Cuff Tendinitis
- What is being tested?
- Platelet Rich Plasma (PRP)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2015to 25 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rotator cuff pathology established by exam
- Rotator cuff pathology confirmed with MRI.
- Failure to improve with activity modification and physical therapy
- Willingness to stop all NSAID medication
Who cannot join
- Additional significant shoulder pathology seen on xray or MRI including: severe arthritis, significant superior labrum anterior postierior (SLAP) Type II lesions and intra-articular loose bodies.
- Shoulder surgery within 6 months.
- Presence of full thickness rotator cuff tears in patients amenable to surgical repair.
Trial locations and contacts
1 site in 1 country.
United States1 site
Illinois Sportsmedicine and Orthopaedic Centers
Glenview, Illinois, 60025
About this study
The purpose of this study is to evaluate the safety and effectiveness of dual platelet rich plasma (PRP) injections into the rotator cuff insertion and the area of the tendon proximal to the insertion.
Read the detailed description
Patients who have rotator cuff pathology as established by clinical exam and confirmed with MRI and have failed activity modification, will be enrolled in this study. They will receive dual platelet rich plasma (PRP) injections, one into the rotator cuff insertion and one into the area of the tendon proximal to the insertion, in one treatment session. PRP will be prepared through a double spin technique to create two 4 cc doses for injection. Patients will evaluated at 6 months, 1 year and two years for improvement in symptoms.
- Conditions
- Rotator Cuff Tears, Rotator Cuff Tendinitis
- Being tested
- Platelet Rich Plasma (PRP)
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich Plasma (PRP)Biological
Platelet Rich Plasma (PRP) prepared from patient blood, spun twice to concentrate platelets. 45 cc of initial blood resulting in 4cc of injectable PRP.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Dual injections of PRP - 4 ml injected into each location. The first injection was into the supraspinatus tendon insertion critical zone and bursal area with the patient seated. The second injection was performed with the patient prone into the glenohumeral intra-articular space under the supraspinatus tendon at, or just proximal to, the superior equator of the humeral head. Receives: Biological: Platelet Rich Plasma (PRP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quick Disabilities of the Arm, Shoulder and Hand Score (Quick-DASH)
Quick-DASH questionnaire consists of 11 questions which are each scored 1-5. The scoring ranges from 0 for best to 100 for worst outcomes.
Measured: change from baseline to 6 months
Quick Disabilities of the Arm, Shoulder and Hand Score (Quick-DASH)
Quick-DASH questionnaire consists of 11 questions which are each scored 1-5. The scoring ranges from 0 for best to 100 for worst outcomes.
Measured: change from baseline to 12 months
Quick Disabilities of the Arm, Shoulder and Hand Score (Quick-DASH)
Quick-DASH questionnaire consists of 11 questions which are each scored 1-5. The scoring ranges from 0 for best to 100 for worst outcomes.
Measured: change from baseline to 24 months
Secondary outcomes (6)
Visual Analog Scale (VAS) for pain
The Visual Analog Scale is a single question about current pain level. Scoring ranges from 0 which is no pain to 100 which is worst possible pain.
Measured: change from baseline to 6 months
Visual Analog Scale (VAS) for pain
The Visual Analog Scale is a single question about current pain level. Scoring ranges from 0 which is no pain to 100 which is worst possible pain.
Measured: change from baseline to 12 months
Visual Analog Scale (VAS) for pain
The Visual Analog Scale is a single question about current pain level. Scoring ranges from 0 which is no pain to 100 which is worst possible pain.
Measured: change from baseline to 24 months
Global Improvement
Global improvement is a single question about percent improved compared to before treatment where 0 is not improved and 100 is completely improved.
Measured: change from baseline to 6 months
Global Improvement
Global improvement is a single question about percent improved compared to before treatment where 0 is not improved and 100 is completely improved.
Measured: change from baseline to 12 months
Global Improvement
Global improvement is a single question about percent improved compared to before treatment where 0 is not improved and 100 is completely improved.
Measured: change from baseline to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start23 Jan 2015
- Primary completion25 Jan 2015
- Study completion25 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Foundation for Orthopaedics and Regenerative Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chadwick Prodromos, MD, Principal investigator, Illinois Sportsmedicine and Orthopaedic Centers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06481046
- Sponsor's protocol ID
- 2015RC
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2020
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Rotator Cuff Tears With Platelet Rich Plasma
- ClinicalTrials.gov ID
- NCT06481046
- Acronym / sponsor ID
- 2015RC
- Conditions
- Rotator Cuff Tears, Rotator Cuff Tendinitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The Foundation for Orthopaedics and Regenerative MedicineUniversity, hospital or other
- Study start
- 23 Jan 2015 (actual)
- Primary completion
- 25 Jan 2015 (actual)
- Study completion
- 25 Jan 2018 (actual)
- First posted
- 1 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and effectiveness of dual platelet rich plasma (PRP) injections into the rotator cuff insertion and the area of the tendon proximal to the insertion.
Detailed description
Patients who have rotator cuff pathology as established by clinical exam and confirmed with MRI and have failed activity modification, will be enrolled in this study. They will receive dual platelet rich plasma (PRP) injections, one into the rotator cuff insertion and one into the area of the tendon proximal to the insertion, in one treatment session. PRP will be prepared through a double spin technique to create two 4 cc doses for injection. Patients will evaluated at 6 months, 1 year and two years for improvement in symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Biological: Platelet Rich Plasma (PRP)Dual injections of PRP - 4 ml injected into each location. The first injection was into the supraspinatus tendon insertion critical zone and bursal area with the patient seated. The second injection was performed with the patient prone into the glenohumeral intra-articular space under the supraspinatus tendon at, or just proximal to, the superior equator of the humeral head. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Rotator cuff pathology established by exam
- Rotator cuff pathology confirmed with MRI.
- Failure to improve with activity modification and physical therapy
- Willingness to stop all NSAID medication
Key exclusion criteria (3 listed)
- Additional significant shoulder pathology seen on xray or MRI including: severe arthritis, significant superior labrum anterior postierior (SLAP) Type II lesions and intra-articular loose bodies.
- Shoulder surgery within 6 months.
- Presence of full thickness rotator cuff tears in patients amenable to surgical repair.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet Rich Plasma (PRP)Platelet Rich Plasma (PRP) prepared from patient blood, spun twice to concentrate platelets. 45 cc of initial blood resulting in 4cc of injectable PRP. | Biological | Treatment Group |
Primary outcome
Quick Disabilities of the Arm, Shoulder and Hand Score (Quick-DASH)
Time frame: change from baseline to 6 months
Quick-DASH questionnaire consists of 11 questions which are each scored 1-5. The scoring ranges from 0 for best to 100 for worst outcomes.
Quick Disabilities of the Arm, Shoulder and Hand Score (Quick-DASH)
Time frame: change from baseline to 12 months
Quick-DASH questionnaire consists of 11 questions which are each scored 1-5. The scoring ranges from 0 for best to 100 for worst outcomes.
Quick Disabilities of the Arm, Shoulder and Hand Score (Quick-DASH)
Time frame: change from baseline to 24 months
Quick-DASH questionnaire consists of 11 questions which are each scored 1-5. The scoring ranges from 0 for best to 100 for worst outcomes.
6 secondary outcomes
Visual Analog Scale (VAS) for pain
Time frame: change from baseline to 6 months
Visual Analog Scale (VAS) for pain
Time frame: change from baseline to 12 months
Visual Analog Scale (VAS) for pain
Time frame: change from baseline to 24 months
Global Improvement
Time frame: change from baseline to 6 months
Global Improvement
Time frame: change from baseline to 12 months
Global Improvement
Time frame: change from baseline to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chadwick Prodromos, MD principal investigator
Illinois Sportsmedicine and Orthopaedic Centers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet Rich Plasma (PRP) in people with Rotator Cuff Tears and Rotator Cuff Tendinitis, run by The Foundation for Orthopaedics and Regenerative Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quick Disabilities of the Arm, Shoulder and Hand Score (Quick-DASH) (time frame: change from baseline to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.