Back to resultsArthroscopic Rotator Cuff Repair Augmented With Platelet Rich Plasma
Primary Purpose
Rotator Cuff Tears
Status
Completed
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Arthroscopic rotator cuff repair
platelet rich plasma
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Tears
Eligibility Criteria
Inclusion Criteria:
- Adults between 50 and 75 years with a defined complete rotator cuff tear as compatible clinical and confirmation by magnetic resonance imaging (MRI).
- Minimum of 3 months of failed conservative treatment (anti-inflammatory, physical therapy and infiltration with corticosteroids)
Exclusion Criteria:
- Refusal to participate or informed consent,
- Revision surgery,
- Partial repair,
- Patients with shoulder osteoarthritis> 2
- Advanced fat infiltration of the rotator cuff muscles (STAGE 3 or 4)
- Systemic or rheumatoid arthritis,
- Uncontrolled diabetes, (patients for whom surgery is contraindicated in the preoperative evaluation by the clinician and anesthesiologist)
- Acute or chronic infections of the shoulder to be operated on
- Ongoing cancer chemotherapy therapies
- Sepsis, septic arthritis, osteomyelitis or other ongoing infectious processes;
- Previous operations on the affected shoulder,
- Patients with autoimmune diseases;
- Pregnant
Sites / Locations
- Hospital Italiano de Buenos Aires
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arthroscopic rotator cuff repair and platelet rich plasma
Arthroscopic rotator cuff repair
Arm Description
A standard double-row arthroscopic rotator cuff repair will be performed and at the end of the procedure 10 ml of autologous platelet-rich plasma will be placed under direct vision at the tendon-bone interface.
A standard double-row arthroscopic rotator cuff repair will be performed.
Outcomes
Primary Outcome Measures
Comparison of re-tear rates between groups.
Postoperative MRI to assess the structural integrity of the repaired rotator cuff.
Secondary Outcome Measures
Change From baseline in shoulder functional scores at 3, 6 and 12 months
The ASES score (American Shoulder and Elbow Surgeons) and the Constant score will be used. Both scores assess the general function of the shoulder in different activities of daily life, global mobility of the shoulder and pain with usual tasks. They are scores ranging from 0 to 100. Both scores are validated and are the reference scores for clinical research on rotator cuff pathology
Change From baseline in pain at 3, 6 and 12 months
The visual analog scale (VAS) will be used to assess the level of pain during activities of daily living. 0 will be considered as "no pain" and 10 as "the worst pain of his life."
Number of Participants With Treatment-Related Adverse Events
Adverse effects and postoperative complications will be recorded.
Full Information
NCT ID
NCT04703998
First Posted
January 3, 2021
Last Updated
December 20, 2022
Sponsor
Hospital Italiano de Buenos Aires
1. Study Identification
Unique Protocol Identification Number
NCT04703998
Brief Title
Arthroscopic Rotator Cuff Repair Augmented With Platelet Rich Plasma
Official Title
Arthroscopic Rotator Cuff Repair Augmented With Platelet Rich Plasma. Prospective Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
January 3, 2021 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
September 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Italiano de Buenos Aires
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Purpose: To assess whether the use of platelet-rich plasma used as an adjuvant to arthroscopic rotator cuff repairs modify the rate of re-tears (measured by MRI) compared to a control group that only underwent the isolated arthroscopic repair. Hypothesis: Platelet rich plasma used as an adjuvant to arthroscopic rotator cuff repairs decrease the rate of retears.
Detailed Description
Platelet-rich plasma used as an adjuvant to arthroscopic rotator cuff repairs modify the rate of re-tears (measured by MRI) compared to a control group that only underwent the isolated arthroscopic repair.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tears
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arthroscopic rotator cuff repair and platelet rich plasma
Arm Type
Experimental
Arm Description
A standard double-row arthroscopic rotator cuff repair will be performed and at the end of the procedure 10 ml of autologous platelet-rich plasma will be placed under direct vision at the tendon-bone interface.
Arm Title
Arthroscopic rotator cuff repair
Arm Type
Active Comparator
Arm Description
A standard double-row arthroscopic rotator cuff repair will be performed.
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic rotator cuff repair
Intervention Description
A double-row rotator cuff repair will be performed.
Intervention Type
Biological
Intervention Name(s)
platelet rich plasma
Intervention Description
A single dose of 10 ml of autologous platelet rich plasma at the bone-tendon interfase will be administered.
Primary Outcome Measure Information:
Title
Comparison of re-tear rates between groups.
Description
Postoperative MRI to assess the structural integrity of the repaired rotator cuff.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change From baseline in shoulder functional scores at 3, 6 and 12 months
Description
The ASES score (American Shoulder and Elbow Surgeons) and the Constant score will be used. Both scores assess the general function of the shoulder in different activities of daily life, global mobility of the shoulder and pain with usual tasks. They are scores ranging from 0 to 100. Both scores are validated and are the reference scores for clinical research on rotator cuff pathology
Time Frame
baseline, 3, 6, and 12 months
Title
Change From baseline in pain at 3, 6 and 12 months
Description
The visual analog scale (VAS) will be used to assess the level of pain during activities of daily living. 0 will be considered as "no pain" and 10 as "the worst pain of his life."
Time Frame
baseline, 3, 6, and 12 months
Title
Number of Participants With Treatment-Related Adverse Events
Description
Adverse effects and postoperative complications will be recorded.
Time Frame
3, 6, and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults between 50 and 75 years with a defined complete rotator cuff tear as compatible clinical and confirmation by magnetic resonance imaging (MRI).
Minimum of 3 months of failed conservative treatment (anti-inflammatory, physical therapy and infiltration with corticosteroids)
Exclusion Criteria:
Refusal to participate or informed consent,
Revision surgery,
Partial repair,
Patients with shoulder osteoarthritis> 2
Advanced fat infiltration of the rotator cuff muscles (STAGE 3 or 4)
Systemic or rheumatoid arthritis,
Uncontrolled diabetes, (patients for whom surgery is contraindicated in the preoperative evaluation by the clinician and anesthesiologist)
Acute or chronic infections of the shoulder to be operated on
Ongoing cancer chemotherapy therapies
Sepsis, septic arthritis, osteomyelitis or other ongoing infectious processes;
Previous operations on the affected shoulder,
Patients with autoimmune diseases;
Pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luciano Rossi, MD
Organizational Affiliation
Hospital Italiano de Buenos Aires
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Italiano de Buenos Aires
City
Caba
Country
Argentina
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
We are planning on sharing the study protocol and the tables contaning all outcomes for every individual patient
IPD Sharing Time Frame
2 years
IPD Sharing Access Criteria
The IPD may be requested to the principal investigator contacting him through e-mail at luciano.rossi@hospitalitaliano.org.ar
Learn more about this trial
Arthroscopic Rotator Cuff Repair Augmented With Platelet Rich Plasma
We'll reach out to this number within 24 hrs