NCT04444076|Unknown
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Sponsor study identifier
interventional
124
1 country
1
Study Start
June 17, 2020
Actual (reported)Primary Completion
February 28, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 28, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This study aims a determine the effect that the addition of REGENETEN Bioinductive Implant has on Supraspinatus Tendon Repair. 120 patients will be included in this prospective, randomized, parallel group study.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 28, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 17, 2020
Actual (reported)June 17, 2020
Actual (reported)June 23, 2020
Actual (reported)February 28, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 28, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Integrity of the tendon repaired in an MRI study one year after the intervention using the Sugaya classification (Sugaya H (2005)).
This is a classification system described by Sugaya et al. which uses magnetic resonance imaging in order to evaluate tendon integrity after rotator cuff repair. Postoperative cuff integrity is classified into 5 categories: type I, sufficient thickness with homogenously low intensity; type II, sufficient thickness with partial high intensity; type III, insufficient thickness without discontinuity; type IV, presence of minor discontinuity; type V, presence of major discontinuity
12 months
Change in pain levels. Measured with questions 3 to 6 of the Brief Pain Inventory.
3 months, 6 months and 12 months after surgery
Functional changes, measured with the Constant-Murley Scale.
3 months, 6 months and 12 months after surgery.
Functional changes, measured with ASES questionnaire.
3 months, 6 months and 12 months after surgery.
Changes in quality of life measured with EQ-5D-5L questionnaire.
3 months, 6 months and 12 months after surgery.
Number of patients with complications in both arms
12 months
REGENETEN bioinductive Implant,a bovine mesh that will be implanted following supraspinatus tendon repair.
Supraspinatus tendon repair.
REGENETEN bioinductive Implant,a reconstituted bovine origin type I collagen mesh with a proprietary high porosity system that is commercialized sterile, dehydrated and desiccated in two sizes (20x26mm and 25x31mm). It will be implanted following supraspinatus tendon repair.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hospital Ramón y Cajal
Madrid, 28034, Spain
Miguel Angel Ruiz Iban, MD, PhD
Hospital Ramón y Cajal, Spain
124 participants (actual enrollment reported by the registry).
First Submitted
June 17, 2020
First Posted
June 23, 2020
Study Start
June 17, 2020
Actual (reported)Treatment of the Biceps With Concomitant Supraspinatus Tears
Contact the study team to confirm eligibility.
Primary Completion
February 28, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 28, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 19, 2024
Record last verified: 2024-09
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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