Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

RECRUITING

InSpace Accelerated Rehabilitation Study

Lead Sponsor:

Stryker Endoscopy

Conditions:

Rotator Cuff Tears

Eligibility:

All Genders

65+ years

Phase:

NA

Brief 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 ...

Detailed Description

Study Objectives: Primary: • To evaluate clinical outcomes of both a formalized or an at-home rehabilitation program when used in conjunction with the InSpace device as compared to the corresponding...

Eligibility Criteria

Inclusion

  • Subjects MUST meet ALL the following criteria to be included in the study:
  • 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
  • Intra-operative Inclusion Criteria
  • Subjects MUST meet the following criteria to be randomized in the study:
  • Full thickness tear
  • Tear size ≥ 5 cm in diameter
  • Tear involving ≥ two tendons

Exclusion

  • Subjects will be excluded from the study, if they meet ANY of the following individual exclusion criteria:
  • Known allergy to the device material (copolymer of PLA (poly (lactic acid) and -ε-caprolactone)
  • Evidence of the following conditions:
  • Severe gleno-humeral or acromio-humeral arthritis
  • Full thickness cartilage loss as seen on MRI
  • History within the past 5 years of anterior or posterior shoulder subluxation or dislocation as determined by history, examination, or radiographic findings
  • Pre-existing deltoid defect or deltoid palsy
  • Major joint trauma, infection, or necrosis
  • Partial thickness tears of the supraspinatus
  • Fully reparable rotator cuff tear \[Tear of less than 5 cm in diameter (or \< 4 cm2) with retractable tendon that can be fully repaired\]
  • Known neurovascular compromise
  • Complete deltoid muscle palsy
  • Traumatic muscle tears of the pectoralis or deltoid
  • The subject requires concomitant:
  • Subscapularis repair
  • Labral repair of any type
  • Biceps tenodesis
  • Previous surgery of the index shoulder in the past 1 year, excluding diagnostic arthroscopy
  • The subject's condition is bilateral and rotator cuff repair is scheduled or to be scheduled over the course of this study for the contra lateral shoulder
  • Major medical condition that could affect quality of life and influence the results of the study (e.g., rheumatoid arthritis)
  • The subject has documented evidence of a history (e.g., liver testing) of drug/alcohol abuse within 12 months of enrollment
  • The subject's condition represents a worker's compensation case
  • The subject is currently involved in a health-related litigation procedure
  • Females of child-bearing potential who are pregnant or plan to become pregnant.
  • Concurrent participation in an investigational clinical study one month prior to enrollment or during the entire study period
  • The subject is physically or mentally compromised (e.g., currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.), to the extent that the Investigator judges the subject to be unable or unlikely to remain compliant to follow-up
  • The subject is receiving prescription narcotic pain medication for conditions unrelated to the index shoulder condition
  • The subject currently has an acute infection in the area surrounding the surgical site.
  • Baseline WORC score less than 420
  • Intra-operative

Key Trial Info

Start Date :

February 7 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2026

Estimated Enrollment :

160 Patients enrolled

Trial Details

Trial ID

NCT05329584

Start Date

February 7 2022

End Date

December 1 2026

Last Update

May 29 2025

Active Locations (11)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 3 (11 locations)

1

Musculoskeletal-Orthopedic Research and Education Foundation

Phoenix, Arizona, United States, 85023

2

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States, 72205

3

Steadman Hawkins Clinic Denver

Englewood, Colorado, United States, 80112

4

Holy Cross Hospital

Fort Lauderdale, Florida, United States, 33308