Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2026-01-02 @ 10:57 AM
Study NCT ID:
NCT01000935
Status:
COMPLETED
Last Update Posted:
2020-03-19
First Post:
2009-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Autologous Platelet Rich Plasma on Healing of Rotator Cuff Repairs
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Study Overview
Official Title:
Impact of Autologous Platelet Rich Plasma on Enhancing Repair of Rotator Cuff Tendons: A Multicentre Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2020-03
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:
Partial-thickness and full-thickness rotator cuff tears are common soft-tissue conditions that often require surgical treatment. Initial efforts to improve tendon healing centered on improving the strength of the repair construct. More recent studies have focused on biologic enhancement of the healing process. The use of platelet concentrates to improve healing, has been explored considerably during the last decade. Platelet Rich Plasma (PRP) is a fraction of plasma that has been isolated and used to enhance regeneration in bone and soft tissues.
There is information on use of PRP in oral surgery, achilles tendon healing, limb lengthening procedures, chronic elbow tendinosis, ruptures/degenerative changes in the patellar tendon, and osteoarthritis of the knee. There are no randomized clinical trials to our knowledge that have examined the impact of PRP in patients with rotator cuff tear.
The objective of the proposed pilot study is to examine the effectiveness of autologous Platelet Rich Plasma (PRP) application in promoting healing of the rotator cuff (RC) tendons following arthroscopic rotator cuff repair through a randomized controlled study.
There is information on use of PRP in oral surgery, achilles tendon healing, limb lengthening procedures, chronic elbow tendinosis, ruptures/degenerative changes in the patellar tendon, and osteoarthritis of the knee. There are no randomized clinical trials to our knowledge that have examined the impact of PRP in patients with rotator cuff tear.
The objective of the proposed pilot study is to examine the effectiveness of autologous Platelet Rich Plasma (PRP) application in promoting healing of the rotator cuff (RC) tendons following arthroscopic rotator cuff repair through a randomized controlled study.
Detailed Description:
Surgical procedures: Arthroscopic inspection of the shoulder will be performed to assess intra-articular structures and to evaluate the rotator cuff and other sub-acromial structures.
Arthroscopic Rotator Cuff Repair: Rotator cuff tears will be categorized as partial-thickness and full-thickness tears. The full-thickness tears will be classified as small (\<1 cm), moderate (1-3 cm), and large (\>3-5 cm) based on the largest dimension and will be treated with a repair using sutures and suture anchors as indicated.
Rehabilitation: A comprehensive protocol with instructions on different types of exercises will be provided pre-operatively. Rehabilitation will be based on the standard protocols for these procedures used at the Holland Centre.
Follow-ups: Patients will be monitored for 6 months, or when participation is terminated by the investigators, or because the patient withdrew consent or fails to return for visits. To evaluate safety, clinical laboratory (WBC, Hb, platelet count, serum chemistry and IL-6, CRP, PT, PTT and INR tests will be conducted at 6 weeks, and 3 months to determine the impact of treatment interventions.
Arthroscopic Rotator Cuff Repair: Rotator cuff tears will be categorized as partial-thickness and full-thickness tears. The full-thickness tears will be classified as small (\<1 cm), moderate (1-3 cm), and large (\>3-5 cm) based on the largest dimension and will be treated with a repair using sutures and suture anchors as indicated.
Rehabilitation: A comprehensive protocol with instructions on different types of exercises will be provided pre-operatively. Rehabilitation will be based on the standard protocols for these procedures used at the Holland Centre.
Follow-ups: Patients will be monitored for 6 months, or when participation is terminated by the investigators, or because the patient withdrew consent or fails to return for visits. To evaluate safety, clinical laboratory (WBC, Hb, platelet count, serum chemistry and IL-6, CRP, PT, PTT and INR tests will be conducted at 6 weeks, and 3 months to determine the impact of treatment interventions.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: