PRP for Rotator Cuff Tears

Rotator Cuff Tears Clinical Trial

Official title:

Platelet - Rich Plasma Injections for Rotator Cuff Tears

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06422390
• Other study ID #: 24-8331
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: July 2025

Study information

• Verified date: June 2024
• Source: Scripps Clinic
• Contact: Emily Martin, MBt
• Phone: 858-554-7011
• Email: martin.emily2[@]scrippshealth.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Regenerative medicine, specifically orthobiologics is a hot topic in the community and in Sports Medicine. Riding the hype curve of a new treatment can be great when offering new procedures to patients. However, as the excitement regarding potential benefits of orthobiologics grows, it is valuable to grow the body of literature on their safety and efficacy in various musculoskeletal conditions. Furthering the body of data regarding which musculoskeletal conditions may benefit most from these treatments and which may not can help guide physicians on when to incorporate orthobiologics into clinical practice. More robust data can help physicians guide patients and patient expectations when discussing treatment options.

Platelet rich plasma (PRP) in musculoskeletal medicine is most commonly used to treat tendinopathies and degenerative joint disease. The American Medical Society for Sports Medicine released a position statement in November of 2021 summarizing meta-analysis and systemic review data evaluating efficacy and major adverse events of PRP for tendinopathy and osteoarthritis1. At this time, the most robust data exists for lateral epicondylopathy as multiple randomized controlled trials demonstrate positive response to PRP. Gluteus medius tendinopathy and plantar fasciaopathy similarly have positive data. In Achilles tendinopathy, well designed RCTs have shown no difference between PRP and saline injections. These data should help guide physicians in responsible use and patient counseling.

Data from Hurley et al. suggest PRP may augment rotator cuff repair with improved rates of healing and reduced overall pain. However, there are limited high quality studies on the efficacy of PRP alone in partial rotator cuff tear. Partial rotator cuff tear is a common musculoskeletal complaint that can be treated with conservative measures such as physical therapy and corticosteroid injection. It can also be treated with surgical intervention if those modalities provide incomplete or inadequate pain relief and functional restoration. This study aims to evaluate if PRP is an efficacious treatment modality for partial rotator cuff tear.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 76
• Est. completion date: July 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Adult patients with symptomatic partial rotator cuff tear of one rotator cuff tendon diagnosed on imaging with MRI

• Adult patients with symptomatic partial rotator cuff tear of one rotator cuff tendon diagnosed on imaging with ultrasound.

Exclusion Criteria:

• Patients who have had any an intervention within the past three months (CSI, PRP, prolotherapy)

• Patient with previous surgical interventions on the same rotator cuff.

• Patients on aspirin who cannot discontinue medication 1 week prior and 6 weeks after the procedure.

• Patients who decline to discontinue anti-inflammatory medications or supplements for 1 week prior and 6 weeks after the procedure.

• Any procedure that utilized less than 2-3 cc of PRP

• Patients that require blood to be drawn twice on the same day.

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tears

Intervention

Biological:
• Platelet - Rich Plasma
Platelet - Rich Plasma is a biologic injection created from the patient's own blood. 52cc of the patient's blood is drawn then mixed with 8cc of anticoagulant. The blood mixture will be spun down using a centrifuge that can separate the platelet-rich plasma from the other contents in the blood. Once the centrifuge process is complete the Platelet - Rich Plasma is ready to be used.

Locations

Country	Name	City	State
United States	Scripps Clinic - Torrey Pines	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
Scripps Clinic

Country where clinical trial is conducted

United States, 

References & Publications (15)

Chen X, Jones IA, Park C, Vangsness CT Jr. The Efficacy of Platelet-Rich Plasma on Tendon and Ligament Healing: A Systematic Review and Meta-analysis With Bias Assessment. Am J Sports Med. 2018 Jul;46(8):2020-2032. doi: 10.1177/0363546517743746. Epub 2017 — View Citation

Chen X, Jones IA, Togashi R, Park C, Vangsness CT Jr. Use of Platelet-Rich Plasma for the Improvement of Pain and Function in Rotator Cuff Tears: A Systematic Review and Meta-analysis With Bias Assessment. Am J Sports Med. 2020 Jul;48(8):2028-2041. doi: 1 — View Citation

DeLong JM, Russell RP, Mazzocca AD. Platelet-rich plasma: the PAW classification system. Arthroscopy. 2012 Jul;28(7):998-1009. doi: 10.1016/j.arthro.2012.04.148. — View Citation

Finnoff JT, Awan TM, Borg-Stein J, Harmon KG, Herman DC, Malanga GA, Master Z, Mautner KR, Shapiro SA. American Medical Society for Sports Medicine Position Statement: Principles for the Responsible Use of Regenerative Medicine in Sports Medicine. Clin J — View Citation

Fitzpatrick J, Bulsara M, Zheng MH. The Effectiveness of Platelet-Rich Plasma in the Treatment of Tendinopathy: A Meta-analysis of Randomized Controlled Clinical Trials. Am J Sports Med. 2017 Jan;45(1):226-233. doi: 10.1177/0363546516643716. Epub 2016 Jul — View Citation

Giovannetti de Sanctis E, Franceschetti E, De Dona F, Palumbo A, Paciotti M, Franceschi F. The Efficacy of Injections for Partial Rotator Cuff Tears: A Systematic Review. J Clin Med. 2020 Dec 25;10(1):51. doi: 10.3390/jcm10010051. — View Citation

Honda H, Gotoh M, Kanazawa T, Nakamura H, Ohta K, Nakamura K, Shiba N. Effects of lidocaine on torn rotator cuff tendons. J Orthop Res. 2016 Sep;34(9):1620-7. doi: 10.1002/jor.23153. Epub 2016 Feb 11. — View Citation

Kesikburun S, Tan AK, Yilmaz B, Yasar E, Yazicioglu K. Platelet-rich plasma injections in the treatment of chronic rotator cuff tendinopathy: a randomized controlled trial with 1-year follow-up. Am J Sports Med. 2013 Nov;41(11):2609-16. doi: 10.1177/03635 — View Citation

Kwong CA, Woodmass JM, Gusnowski EM, Bois AJ, Leblanc J, More KD, Lo IKY. Platelet-Rich Plasma in Patients With Partial-Thickness Rotator Cuff Tears or Tendinopathy Leads to Significantly Improved Short-Term Pain Relief and Function Compared With Corticos — View Citation

Prodromos CC, Finkle S, Prodromos A, Chen JL, Schwartz A, Wathen L. Treatment of Rotator Cuff Tears with platelet rich plasma: a prospective study with 2 year follow-up. BMC Musculoskelet Disord. 2021 May 29;22(1):499. doi: 10.1186/s12891-021-04288-4. — View Citation

Reilly P, Macleod I, Macfarlane R, Windley J, Emery RJ. Dead men and radiologists don't lie: a review of cadaveric and radiological studies of rotator cuff tear prevalence. Ann R Coll Surg Engl. 2006 Mar;88(2):116-21. doi: 10.1308/003588406X94968. — View Citation

Rossi LA, Piuzzi N, Giunta D, Tanoira I, Brandariz R, Pasqualini I, Ranalletta M. Subacromial Platelet-Rich Plasma Injections Decrease Pain and Improve Functional Outcomes in Patients With Refractory Rotator Cuff Tendinopathy. Arthroscopy. 2021 Sep;37(9): — View Citation

Snow M, Hussain F, Pagkalos J, Kowalski T, Green M, Massoud S, James S. The Effect of Delayed Injection of Leukocyte-Rich Platelet-Rich Plasma Following Rotator Cuff Repair on Patient Function: A Randomized Double-Blind Controlled Trial. Arthroscopy. 2020 — View Citation

Sung CM, Hah YS, Kim JS, Nam JB, Kim RJ, Lee SJ, Park HB. Cytotoxic effects of ropivacaine, bupivacaine, and lidocaine on rotator cuff tenofibroblasts. Am J Sports Med. 2014 Dec;42(12):2888-96. doi: 10.1177/0363546514550991. Epub 2014 Oct 8. — View Citation

Thepsoparn M, Thanphraisan P, Tanpowpong T, Itthipanichpong T. Comparison of a Platelet-Rich Plasma Injection and a Conventional Steroid Injection for Pain Relief and Functional Improvement of Partial Supraspinatus Tears. Orthop J Sports Med. 2021 Sep 1;9 — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of pain and function	Primary outcome: Improvement in patients' subjective pain and function as measured by the American Shoulder and Elbow Surgeons (ASES) score at 6 weeks, 12 weeks, 6 months, and 1 year.; Minimum value: No difficulty with normal function of the shoulder and there is no pain.; Maximum value: Extreme difficulty with normal function and the pain is as bad as it can be.; Pain scale is 0 to 10 with the meaning that scale starts from 0 (no pain) to 10 (pain as bad as it can be).	June 2024 to June 2025
Secondary	Improvement in VAS scores and patient satisfaction	Secondary Outcome: Improvement in visual analog scale (VAS) pain scores at 6 weeks, 12 weeks, 6 months, and 1 year. Additional secondary outcomes: Patients' perception of overall improvement with their shoulder, patient satisfaction with outcome, tendon healing assessed by ultrasound evaluation, progression to surgical management or other intervention such as corticosteroid injections (CSI), and association between volume of Plasma Rich Platelet (PRP) and outcomes.; The visual analog scale (VAS): No pain (0) - mild pain (1-2) - moderate pain (3-4) - Severe Pain (5-6) - Very sever pain (7-8) - Worst possible pain (9-10); The higher the number the worst the outcome is. The lower the number the better the outcome is.	June 2024 to June 2025