InSpace Accelerated Rehabilitation Study

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.

Conditions

Rotator Cuff Tears

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Study Overview

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Study Details

Study overview

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.

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

InSpace Accelerated Rehabilitation Study

Condition
Rotator Cuff Tears
Intervention / Treatment

-

Contacts and Locations

Phoenix

Musculoskeletal-Orthopedic Research and Education Foundation, Phoenix, Arizona, United States, 85023

Little Rock

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States, 72205

Englewood

Steadman Hawkins Clinic Denver, Englewood, Colorado, United States, 80112

Fort Lauderdale

Holy Cross Hospital, Fort Lauderdale, Florida, United States, 33308

West Palm Beach

Paley Orthopaedics & Spine, West Palm Beach, Florida, United States, 33407

Atlanta

Emory University, Atlanta, Georgia, United States, 30329

Chicago

Rush University Medical Center, Chicago, Illinois, United States, 60612

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

New York

Hospital for Special Surgery, New York, New York, United States, 10021

Philadelphia

The Rothman Institute, Philadelphia, Pennsylvania, United States, 19107

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

65 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Stryker Endoscopy,

Colleen Roden, MS, STUDY_DIRECTOR, Stryker Endoscopy

Study Record Dates

2026-04