Clinical trial NCT06422390: PRP for Rotator Cuff Tears
Official title: Platelet - Rich Plasma Injections for Rotator Cuff Tears
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Rotator Cuff Tears
Keywords: PRP
Lead sponsor: Scripps Clinic
Sponsor class: OTHER
First posted: 2024-05-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are 18 years or older but 90 years or younger with a diagnosis of a symptomatic partial rotator cuff tear of one rotator cuff tendon.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Improvement of pain and function
timeFrame: June 2024 to June 2025
Secondary outcomes:
measure: Improvement in VAS scores and patient satisfaction
timeFrame: June 2024 to June 2025
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Clinic - Torrey Pines
state: California
Study officials:
affiliation: Scripps Clinic Medical Group
name: Laika Nur, MD
role: PRINCIPAL_INVESTIGATOR
References:
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 Sport Med. 2021 Nov 1;31(6):530-541. doi: 10.1097/JSM.0000000000000973.
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.
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.
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 Corticosteroid Injection: A Double-Blind Randomized Controlled Trial. Arthroscopy. 2021 Feb;37(2):510-517. doi: 10.1016/j.arthro.2020.10.037. Epub 2020 Oct 28.
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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.
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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.
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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):2745-2753. doi: 10.1016/j.arthro.2021.03.079. Epub 2021 Apr 20.
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