Vascular Changes of Rotator Cuff Repair Augmented With a Whole Blood Fibrin Clot

NCT03577379 | Completed DMC

• 1 other identifier: 17-34
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to assess whether undergoing surgical repair of the rotator cuff with the additional intervention of whole blood fibrin clot will improve rotator cuff vascularization at the bone-tendon interface repair site and patient outcomes compared to those who do not receive the whole blood fibrin clot intervention.

Conditions

Rotator Cuff Tear

Keywords

Rotator cuff repair, whole blood fibrin clot

Outcome Measures

Primary Outcomes (1)

• Vascularity Index

  Vascularity or the structural outcome will be assessed at 6 weeks postoperatively using the vascularity index scoring system described in Zumstein et al., (2014).

  Assessed 6 weeks postoperatively.

Secondary Outcomes (5)

• Visual Analog Scale (VAS)

  Assessed at baseline and at 1 week, 3 weeks, and then at 3 and 6 months.

• Western Ontario Rotator Cuff Index

  Assessed at baseline, and 3 and 6 months.

• Veterans Rand (VR-12)

  Assessed at baseline, and 3 and 6 months.

• American Shoulder and Elbow Surgeons Score (ASES)

  Assessed at baseline and at 3 and 6 month.

• Single Assessment Numeric Evaluation Score (SANE)

  Assessed at 3 and 6 months.

Study Arms (2)

Control

NO INTERVENTION

Patients in the control arm will receive standard of care for their rotator cuff tear, and will not receive the additional whole blood fibrin clot.

Treatment

EXPERIMENTAL

Patients in the control arm will receive standard of care for their rotator cuff tear, in addition to, the whole blood fibrin clot.

Other: Whole Blood Fibrin Clot

Interventions

Whole Blood Fibrin Clot OTHER

For all patients assigned to the treatment group, 35mL of whole blood will be obtained during surgery by an anesthesiologist. 5 mL of the blood will be sent for pre-clot formation cell count evaluation for platelets, red blood cells and white blood cells. The remaining 30mL will be placed into a sterile container with a sintered glass cylinder supported by the lid for fibrin clot formation. The clot formation cups will be placed on a rotator at room temperature for 10 minutes at 125rpm. The fibrin clot will be removed and 5mL of the post-clot serum sent for post-clot formation cell count evaluation for platelets, red blood cells, and white blood cells.

Treatment

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Presence of ultrasonographic or magnetic resonance imaging (MRI) documented rotator cuff tear confirmed at surgery to be a medium to large-sized rotator cuff tear (\> 1 cm), which requires intervention due to persistent difficulty in elevation of affected shoulder and/or pain; 2) ability to give informed consent for procedure, rehabilitation, and regular clinical and radiologic follow-up for a minimum period of 6 most post-surgery; and have 3) preoperative blood platelet counts \>150,000/microliter.

You may not qualify if:

• \) they have a type III subscapularis tear and above due to different rehabilitation protocol; 2) massive, partial, or traumatic cuff tears; 3) partial or incomplete repairs; 4) is a chronic smoker or patient with Parkinson's disease; 5) have a condition that may hinder healing or attending follow-up visits (e.g., diabetes, immunocompromised status, chemotherapy treatment, chronic steroid use); and 6) age \>70.

Sponsors & Collaborators

• Santa Barbara Cottage Hospital: lead

Study Sites (1)

De La Vina Surgery Center

Santa Barbara, California, 93101, United States

Location

Related Publications (2)

• Proctor CS. Long-term successful arthroscopic repair of large and massive rotator cuff tears with a functional and degradable reinforcement device. J Shoulder Elbow Surg. 2014 Oct;23(10):1508-13. doi: 10.1016/j.jse.2014.01.010. Epub 2014 Apr 13.

  PMID: 24725892 BACKGROUND

• Proctor CS. Rotator cuff repair augmented with endogenous fibrin clot. Arthrosc Tech. 2012 May 18;1(1):e79-82. doi: 10.1016/j.eats.2012.03.002. Print 2012 Sep.

  PMID: 23766981 RESULT

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Patients will be randomized to either the treatment or control group using an automated randomization program using a research electronic data capture (REDCap) system prior to surgery.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Managing Partner, Alta Orthopaedics

Study Record Dates

• First Submitted: June 23, 2018
• First Posted: July 5, 2018
• Study Start: March 1, 2019
• Primary Completion: April 25, 2022
• Study Completion: April 25, 2022
• Last Updated: May 5, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)