RECRUITING

InSpace Accelerated Rehabilitation Study

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

An Assessment of Two Accelerated Rehabilitation Programs for Use With the InSpaceTM Subacromial Tissue Spacer System in the Treatment of Full-thickness Massive, Irreparable Rotator Cuff Tears

Quick Facts

Study Start:2022-02-07

Study Completion:2026-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05329584

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* The subject has signed the IRB approved Informed Consent Form (ICF) specific to this study prior to enrollment * Is male or female ≥ sixty-five (65) years of age * Positive diagnostic imaging by MRI within 9 months of enrollment of the index shoulder indicating a full thickness MRCT: * Measuring ≥ 5 cm in diameter * Involving ≥ two tendons * Functional deltoid muscle and preserved passive range of motion on physical examination * Documented VAS score \> 30 mm pain * Failed non-operative treatment of at least 3 months from the initial treatment to include one or more of the following: * Oral analgesics * Anti-inflammatory medication (e.g., ibuprofen, naproxen) * Corticosteroid injection(s) * Physical therapy * Activity modification * Rest (sling used) * Must be able to read and understand the approved Informed Consent Form (written and oral) * Must be in general good health (as determined by the Investigator) based on screening assessments and medical history * Must be independent, ambulatory, and can comply with all post-operative evaluations, visits, and electronic database collection * Full thickness tear * Tear size ≥ 5 cm in diameter * Tear involving ≥ two tendons	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion Criteria

* The subject has signed the IRB approved Informed Consent Form (ICF) specific to this study prior to enrollment
* Is male or female ≥ sixty-five (65) years of age
* Positive diagnostic imaging by MRI within 9 months of enrollment of the index shoulder indicating a full thickness MRCT:
* Measuring ≥ 5 cm in diameter
* Involving ≥ two tendons
* Functional deltoid muscle and preserved passive range of motion on physical examination
* Documented VAS score \> 30 mm pain
* Failed non-operative treatment of at least 3 months from the initial treatment to include one or more of the following:
* Oral analgesics
* Anti-inflammatory medication (e.g., ibuprofen, naproxen)
* Corticosteroid injection(s)
* Physical therapy
* Activity modification
* Rest (sling used)
* Must be able to read and understand the approved Informed Consent Form (written and oral)
* Must be in general good health (as determined by the Investigator) based on screening assessments and medical history
* Must be independent, ambulatory, and can comply with all post-operative evaluations, visits, and electronic database collection
* Full thickness tear
* Tear size ≥ 5 cm in diameter
* Tear involving ≥ two tendons

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

Hayley Taylor, MS

CONTACT

805-705-4206

hayley.taylor@stryker.com

Principal Investigator

Colleen Roden, MS

STUDY_DIRECTOR

Stryker Endoscopy

Study Locations (Sites)

Musculoskeletal-Orthopedic Research and Education Foundation

Phoenix, Arizona, 85023

United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205

United States

Steadman Hawkins Clinic Denver

Englewood, Colorado, 80112

United States

Holy Cross Hospital

Fort Lauderdale, Florida, 33308

United States

Paley Orthopaedics & Spine

West Palm Beach, Florida, 33407

United States

Emory University

Atlanta, Georgia, 30329

United States

Rush University Medical Center

Chicago, Illinois, 60612

United States

Mayo Clinic

Rochester, Minnesota, 55905

United States

Hospital for Special Surgery

New York, New York, 10021

United States

The Rothman Institute

Philadelphia, Pennsylvania, 19107

United States

TSAOG Orthopaedics & Spine

San Antonio, Texas, 78258

United States

Collaborators and Investigators

Sponsor: Stryker Endoscopy

Colleen Roden, MS, STUDY_DIRECTOR, Stryker Endoscopy

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-07

Study Completion Date2026-04

Study Record Updates

Study Start Date2022-02-07

Study Completion Date2026-04

Terms related to this study

Additional Relevant MeSH Terms

Rotator Cuff Tears