InSpace Accelerated Rehabilitation Study

NCT05329584 | Recruiting FDA Device

• 1 other identifier: SYK-SM-2021-01
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 11

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 Massive, Irreparable Rotator Cuff Tears (MIRCTs) performed during an arthroscopic procedure.

Conditions

Rotator Cuff Tears

Outcome Measures

Primary Outcomes (1)

• Change in American Shoulder and Elbow (ASES) Score

  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 patients undergoing rotator cuff repair as 11.1 and 17.5, respectively. Change in American Shoulder and Elbow Surgeons (ASES) Score will be expressed as the percentages demonstrating a minimal clinical important difference (MCID; ASES ≥ 11.1) and the substantial clinical benefit (SCB; ASES ≥ 17.5) in ASES from baseline at Month 12. Minimum value: 0, Maximum value: 100 (with a higher score indicating a better outcome).

  Day 0 through Month 12

Secondary Outcomes (11)

• Safety Assessment

  Day 0 through Month 24

• Change in Western Ontario Rotator Cuff (WORC) Score

  Day 0 through Month 24

• Change in Constant Score (CS) Outcome Score

  Day 0 through Month 24

• Change in EuroQol 5-Dimensions Questionnaire (EQ-5D-5L) Score

  Day 0 through Month 24

• Change in Visual Analog Scale (VAS) Score

  Day 0 through Month 24

Study Arms (2)

Group I

EXPERIMENTAL

InSpace device + accelerated rehabilitation in a formalized program (FP)

Device: InSpace Subacromial Tissue Spacer

Group II

EXPERIMENTAL

InSpace device + accelerated rehabilitation in an at-home program (AHP)

Device: InSpace Subacromial Tissue Spacer

Interventions

InSpace Subacromial Tissue Spacer DEVICE

Rotator Cuff Tear Treatment

Group I; Group II

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Stryker Endoscopy: lead

Study Sites (11)

Musculoskeletal-Orthopedic Research and Education Foundation

Phoenix, Arizona, 85023, United States

RECRUITING

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

RECRUITING

Steadman Hawkins Clinic Denver

Englewood, Colorado, 80112, United States

RECRUITING

Holy Cross Hospital

Fort Lauderdale, Florida, 33308, United States

RECRUITING

Paley Orthopaedics & Spine

West Palm Beach, Florida, 33407, United States

RECRUITING

Emory University

Atlanta, Georgia, 30329, United States

RECRUITING

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Hospital for Special Surgery

New York, New York, 10021, United States

RECRUITING

The Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

TSAOG Orthopaedics & Spine

San Antonio, Texas, 78258, United States

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Colleen Roden, MS

  Stryker Endoscopy

  STUDY DIRECTOR

Central Study Contacts

Hayley Taylor, MS

CONTACT

805-705-4206; hayley.taylor@stryker.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: April 15, 2022
• Study Start: February 7, 2022
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)