Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06422390
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-05-15
Brief Title:
PRP for Rotator Cuff Tears
Sponsor:
Scripps Clinic
Organization:
Scripps Clinic
Study Overview
Official Title:
Platelet - Rich Plasma Injections for Rotator Cuff Tears
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None