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NCT07027735 · ClinicalTrials.gov registry record · NA
Decellularized Human Placental Extracellular Matrix Tissue for Rotator Cuff Repair Augmentation
A NA study, sponsored by Columbia University.
- Recruiting
- Registry status
- NA
- Development phase
- 120
- Enrollment target
NCT07027735: Recruiting NA study, sponsored by Columbia University.
NCT07027735 is a NA study that is actively recruiting participants, run by Columbia University. The registered enrollment target is 120 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07027735, a NA study, is actively recruiting participants, sponsored by Columbia University.
- RECRUITING
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
Study Summary
The rotator cuff is a set of muscles and tendons that help move the shoulder. Tears in the rotator cuff are common, particularly as people age. Consequently, rotator cuff repair surgeries are common, as well. Despite the frequency with which rotator cuff repairs are performed, there remains a high rate of postoperative failure to heal. In such situations, there is a lack of connective tissue establishment between the rotator cuff tendon and the bone. One strategy to attempt to improve healing of the rotator cuff tendon back to the bone is via the use of extracellular matrix allograft. This treatment is composed of tissue from other humans, which is stripped of its cells so that just the scaffolding around the cells remains. This decellularized scaffolding can be placed at the rotator cuff healing site in an attempt to augment healing. Both animal studies and human studies have shown promise with this approach. Of those patients enrolling in the study, 50% will be assigned at random to receive a standard rotator cuff repair AND allograft treatment, while 50% will be assigned at random to receive standard rotator cuff repair WITHOUT allograft treatment. All patients enrolled in the study will also obtain an MRI at one year following surgery in order to assess tendon healing. Of note, one-year postoperative MRIs are not standard following rotator cuff repair - only those enrolled in the study will receive this MRI. There will be no financial consequence of receiving this MRI.
Primary Outcome
The primary outcome measure will be the postoperative retear rate, measured on one-year postoperative MRI
Interventions
- OTHER Rotator Cuff Repair with Allograft Patch
- OTHER Rotator Cuff Repair with No Augmentation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2026-08 |
| Est. Completion | 2027-07-01 |
| Phase | NA |
What NCT07027735 shows while recruiting
NCT07027735 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Rotator Cuff Repair with Allograft Patch is the first listed.
NCT07027735 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07027735 about?
NCT07027735 is a clinical study titled "Decellularized Human Placental Extracellular Matrix Tissue for Rotator Cuff Repair Augmentation". The rotator cuff is a set of muscles and tendons that help move the shoulder. Tears in the rotator cuff are common, particularly as people age. Consequently, rotator cuff repair surgeries are common, as well. Despite the frequency with which rotator cuff repairs are performed, there remains a high r...
What is the current status of trial NCT07027735?
This trial is currently recruiting. It is a NA study. The enrollment target is 120 participants. The study started on 2026-08. Estimated completion is 2027-07-01.
What interventions are being tested in trial NCT07027735?
The interventions under investigation include: Rotator Cuff Repair with Allograft Patch (OTHER), Rotator Cuff Repair with No Augmentation (OTHER).
Who is sponsoring clinical trial NCT07027735?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07027735's enrollment target sits among peer trials
120 762nd of 2000 higher than 1,198 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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