Status:
WITHDRAWN
Use of Nanoscaffold Augmentation in Rotator Cuff Repair: Clinical Outcome and Ultrasound Assessment of Healing Rates and Vascularity
Lead Sponsor:
Joshua Szabo, MD
Collaborating Sponsors:
Atreon Orthopedics
Conditions:
Rotator Cuff Tears
Rotator Cuff Injuries
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The purpose is to assess Rotium, a novel nanoscaffold, impact on healing of a repaired rotator cuff and compare to a repair without Rotium. Animal (sheep) models have shown both quicker and more organ...
Detailed Description
Patients indicated for rotator cuff repair surgery will be offered participation within the study and consented accordingly. A copy of the consent will be provided to the participant. A preoperative u...
Eligibility Criteria
Inclusion
- -symptomatic supraspinatus or supraspinatus and infraspinatus tear that can be repaired to the greater tuberosity in an anatomical manner using a dual layer repair technique.
- also included will be patients that have concomitant pathology addressed at time of surgery, specifically pathologies of the biceps tendon (tenodesis or tenotomy), arthrosis of the acromioclavicular joint (distal clavicle resection), or labral tearing (debridement or repair)
- included age range of subjects will be from 18-80 years old
Exclusion
- diabetes, cancer or medical states that may impair healing, such as organ transplantation or systemic inflammatory process treated with immune modulating drugs (chemotherapy, immunosuppression drugs)
- prior surgery to the ipsilateral rotator cuff tendon
- need of soft tissue releases to accomplish an anatomic repair, partial repairs and/or concomitant subscapularis repair
- significant glenohumeral arthritis
- active or ongoing infection
- pregnancy
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04361266
Start Date
August 1 2022
End Date
November 1 2023
Last Update
October 18 2022
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