InSpace Accelerated Rehabilitation Study

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Stryker Endoscopy
Study ID
NCT05329584
Status
Recruiting
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Conditions

  • Rotator Cuff Tears

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • InSpace Subacromial Tissue Spacer — DEVICE
    Rotator Cuff Tear Treatment

Study Details

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.

Key Dates

Start date
Feb 7, 2022
Status verified
May 2025
Primary completion
Apr 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group I
    InSpace device + accelerated rehabilitation in a formalized program (FP)
  • Experimental: Group II
    InSpace device + accelerated rehabilitation in an at-home program (AHP)

Primary Outcome Measure

Change in American Shoulder and Elbow (ASES) Score [ Time Frame: Day 0 through Month 12 ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
Musculoskeletal-Orthopedic Research and Education FoundationPhoenixArizona85023
Michael Amini, MD (PRINCIPAL_INVESTIGATOR)
Michael Rose, MD (SUB_INVESTIGATOR)
John Brown, MD (SUB_INVESTIGATOR)
University of Arkansas for Medical SciencesLittle RockArkansas72205
Dana Garrison
[email protected]
Lawrence O'Malley (PRINCIPAL_INVESTIGATOR)
Charles Pearce (SUB_INVESTIGATOR)
Steadman Hawkins Clinic DenverEnglewoodColorado80112
Lauren Heylmun
[email protected]
James Genuario (PRINCIPAL_INVESTIGATOR)
Brayden Mayer (SUB_INVESTIGATOR)
Martin Boublik (SUB_INVESTIGATOR)
Thomas Noonan (SUB_INVESTIGATOR)
Adam Seidl (SUB_INVESTIGATOR)
Holy Cross HospitalFort LauderdaleFlorida33308
David Henderson
[email protected]
Ross Wodika, MD (PRINCIPAL_INVESTIGATOR)
Paley Orthopaedics & SpineWest Palm BeachFlorida33407
Janice Schuck
[email protected]
Jonathan Levy, MD (PRINCIPAL_INVESTIGATOR)
Emory UniversityAtlantaGeorgia30329
Isabelle Vernon
[email protected]
Eric Wagner, MD (PRINCIPAL_INVESTIGATOR)
Michael Gottschalk, MD (SUB_INVESTIGATOR)
Rush University Medical CenterChicagoIllinois60612
Kavita Ahuja
[email protected]
Mukesh Ahuja
[email protected]
Nikhil Verma, MD (PRINCIPAL_INVESTIGATOR)
Gregory Nicholson, MD (SUB_INVESTIGATOR)
Brian Cole, MD (SUB_INVESTIGATOR)
Grant Garrigues, MD (SUB_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55905
Lindsey Hobbs
[email protected]
Joaquin Sanchez Sotelo (PRINCIPAL_INVESTIGATOR)
Hospital for Special SurgeryNew YorkNew York10021
Anthony Finocchiaro
[email protected]
Michael Fu, MD (PRINCIPAL_INVESTIGATOR)
Joshua Dines, MD (SUB_INVESTIGATOR)
The Rothman InstitutePhiladelphiaPennsylvania19107
Thema Nicholson
[email protected]
Joseph Abboud, MD (PRINCIPAL_INVESTIGATOR)
TSAOG Orthopaedics & SpineSan AntonioTexas78258
Amanda Strickland
[email protected]
Robert Hartzler, MD (PRINCIPAL_INVESTIGATOR)
Lane Naugher, MD (SUB_INVESTIGATOR)
Sergio Viroslav, MD (SUB_INVESTIGATOR)

Find similar trials in Phoenix, AZ

By research site
Musculoskeletal-Orthopedic Research and Education Foundation· Phoenix, AZUniversity of Arkansas for Medical Sciences· Little Rock, ARSteadman Hawkins Clinic Denver· Englewood, COHoly Cross Hospital· Fort Lauderdale, FLPaley Orthopaedics & Spine· West Palm Beach, FLEmory University· Atlanta, GA

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