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NCT05329584 · ClinicalTrials.gov registry record · NA
InSpace Accelerated Rehabilitation Study
A NA study of Rotator Cuff Tears, sponsored by Stryker Endoscopy.
- Recruiting
- Registry status
- NA
- Development phase
- 160
- Enrollment target
- 11
- Study locations
NCT05329584: Recruiting NA study of Rotator Cuff Tears, sponsored by Stryker Endoscopy.
NCT05329584 is a NA study of Rotator Cuff Tears that is actively recruiting participants, run by Stryker Endoscopy. The registered enrollment target is 160 participants, below the 1,273-participant average among 20 other Rotator Cuff Tears trials with a reported enrollment target (87% lower). The trial reports 11 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05329584, a NA study of Rotator Cuff Tears, is actively recruiting participants, sponsored by Stryker Endoscopy.
- RECRUITING
- Registry status
- NA
- Development phase
- 160 participants
- Enrollment target
- 11
- Study locations
Study Summary
This is a prospective, parallel group, open-label, multi- center, randomized study to assess two accelerated rehabilitation programs for use with the InSpace device in the treatment of full thickness Massive, Irreparable Rotator Cuff Tears (MIRCTs) performed during an arthroscopic procedure.
Primary Outcome
This is a subject self-report questionnaire and Investigator assessment questionnaire. The subject portion collects information on activities of daily living (i.e., 10 questions). The Investigator assessment portion documents ROM (forward elevation/flexion, external rotation, internal rotation, cross-body adduction), signs, strength, and instability. ASES minimal clinical important difference (MCID) and substantial clinical benefit (SCB) have been previously described for the ASES score in patie
Conditions Studied
Interventions
- DEVICE InSpace Subacromial Tissue Spacer
Study Locations (11)
Florida
- Holy Cross Hospital - Fort Lauderdale
- Paley Orthopaedics & Spine - West Palm Beach
Arizona
- Musculoskeletal-Orthopedic Research and Education Foundation - Phoenix
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Colorado
- Steadman Hawkins Clinic Denver - Englewood
Georgia
- Emory University - Atlanta
Illinois
- Rush University Medical Center - Chicago
Minnesota
- Mayo Clinic - Rochester
New York
- Hospital for Special Surgery - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2022-02-07 |
| Est. Completion | 2026-12 |
| Phase | NA |
What NCT05329584 shows while recruiting
NCT05329584 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 1,273-participant average among 20 other Rotator Cuff Tears trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Rotator Cuff Tears appearing as the primary indexed condition, and to 1 intervention - of which InSpace Subacromial Tissue Spacer is the first listed.
NCT05329584 lists 11 locations in 10 states (Florida, Arizona, Arkansas).
Frequently Asked Questions
What is clinical trial NCT05329584 about?
NCT05329584 is a clinical study titled "InSpace Accelerated Rehabilitation Study". This is a prospective, parallel group, open-label, multi- center, randomized study to assess two accelerated rehabilitation programs for use with the InSpace device in the treatment of full thickness Massive, Irreparable Rotator Cuff Tears (MIRCTs) performed during an arthroscopic procedure.
What is the current status of trial NCT05329584?
This trial is currently recruiting. It is a NA study. The enrollment target is 160 participants. The study started on 2022-02-07. Estimated completion is 2026-12.
What conditions does trial NCT05329584 study?
This clinical trial studies the following conditions: Rotator Cuff Tears.
What interventions are being tested in trial NCT05329584?
The interventions under investigation include: InSpace Subacromial Tissue Spacer (DEVICE).
Who is sponsoring clinical trial NCT05329584?
This trial is sponsored by Stryker Endoscopy, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05329584 being conducted?
This trial has 11 study locations across Arizona, Arkansas, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Rotator Cuff Tears
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05329584's enrollment target sits among peer trials
160 6th of 20 higher than 14 of 20 other Rotator Cuff Tears trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rotator Cuff Tears 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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