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NCT06735170 · ClinicalTrials.gov registry record · Phase 1
Tuberoplasty Versus Balloon Spacer
A Phase 1 study of Rotator Cuff Tears, sponsored by University of Minnesota.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT06735170 is a Phase 1 study of Rotator Cuff Tears that is actively recruiting participants, run by University of Minnesota. The registered enrollment target is 40 participants, below the 1,279-participant average among 20 other Rotator Cuff Tears trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06735170, a Phase 1 study of Rotator Cuff Tears, is actively recruiting participants, sponsored by University of Minnesota.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to examine bone-to-bone contact between the tuberosity as compared to a subacromial balloon spacer procedure. Using biplanar fluoroscopy to determine the three-dimensional (3D) motion of the shoulder compared pre-procedure to post-procedure, the investigators will be able to assess 1) the bone-to-bone contact of the tuberosity and acromion in the setting of a massive posterior superior rotator cuff tear 2) if the placement of a dermal allograft over the tuberosity does indeed decrease bone contact and 3) if the placement of a subacromial balloon spacer decreases bone-to-bone contact. Doing so will allow assessment of the relative contribution of the implant for arm elevation versus potential compensatory motion of increased scapulothoracic motion. The investigators will also be able to correlate this to patient-reported outcomes of pain and shoulder function.
Conditions Studied
Interventions
- PROCEDURE biologic tuberoplasty
- PROCEDURE subacromial balloon spacer
Study Locations (1)
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-12-02 |
| Est. Completion | 2026-11-26 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06735170
The ClinicalTrials.gov registry entry for NCT06735170 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,279-participant average among 20 other Rotator Cuff Tears trials with a reported enrollment target (97% lower). The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Rotator Cuff Tears appearing as the primary indexed condition, and to 2 interventions - of which biologic tuberoplasty is the first listed.
NCT06735170 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT06735170 about?
NCT06735170 is a clinical study titled "Tuberoplasty Versus Balloon Spacer". The purpose of this study is to examine bone-to-bone contact between the tuberosity as compared to a subacromial balloon spacer procedure. Using biplanar fluoroscopy to determine the three-dimensional (3D) motion of the shoulder compared pre-procedure to post-procedure, the investigators will be abl...
What is the current status of trial NCT06735170?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2024-12-02. Estimated completion is 2026-11-26.
What conditions does trial NCT06735170 study?
This clinical trial studies the following conditions: Rotator Cuff Tears.
What interventions are being tested in trial NCT06735170?
The interventions under investigation include: biologic tuberoplasty (PROCEDURE), subacromial balloon spacer (PROCEDURE).
Who is sponsoring clinical trial NCT06735170?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06735170 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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