A Pivotal Study to Assess the InSpace™ Device for Treatment of Full Thickness Massive Rotator Cuff Tears
Public ClinicalTrials.gov record NCT02493660. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Prospective, Single Blinded, Multi-center, Randomized, Controlled, Pivotal Study to Assess the Safety and Effectiveness of the InSpace™ Device for Treatment of Full Thickness Massive Rotator Cuff Tears
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
A pivotal study to assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical partial repair of full thickness Massive Rotator Cuff Tear (MRCT).
Study identification
- NCT ID
- NCT02493660
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 184 participants
Conditions and interventions
Conditions
Interventions
- InSpace sub-acromial tissue spacer system Device
- Partial repair of rotator cuff Procedure
Device · Procedure
Eligibility (public fields only)
- Age range
- 40 Years to 100 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 26, 2015 (Actual)
- Primary completion
- Feb 29, 2020 (Actual)
- Completion
- Mar 17, 2020 (Actual)
- Last update posted
- Jun 15, 2022
2015 – 2020
United States locations
- U.S. sites
- 18
- U.S. states
- 11
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Southern California Orthopedic Institute | Van Nuys | California | 91405 | — |
| University of Colorado | Denver | Colorado | 80222 | — |
| Holy Cross Hospital | Fort Lauderdale | Florida | 33334 | — |
| Midwest Orthopedics at RUSH | Chicago | Illinois | 60612 | — |
| Rockford Orthopedic Associates | Rockford | Illinois | 51107 | — |
| Tulane University School of Medicine | New Orleans | Louisiana | 70112 | — |
| Johns Hopkins | Baltimore | Maryland | 21205-1911 | — |
| MedStar Union Memorial Orthopaedics | Baltimore | Maryland | 21218 | — |
| Brigham & Women's Hospital | Boston | Massachusetts | 02166 | — |
| NYU | New York | New York | 10016 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| University of Buffalo Buffalo | New York | New York | 14260 | — |
| Upstate Orthopedics | Syracuse | New York | 13057 | — |
| Cincinnati SportsMedicine and Orthopaedic Center - Mercy Health | Cincinnati | Ohio | 45209 | — |
| The Ohio State University | Ohio City | Ohio | 43210 | — |
| Rothman Institute | Philadelphia | Pennsylvania | 19152 | — |
| University Orthopedic Center | State College | Pennsylvania | 16801 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02493660, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 15, 2022 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02493660 live on ClinicalTrials.gov.