Clinical trial NCT05329584: InSpace Accelerated Rehabilitation Study
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rotator Cuff Tears
Lead sponsor: Stryker Endoscopy
Sponsor class: INDUSTRY
First posted: 2022-04-15
Enrollment: 160
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 InSpace Pivotal study results.

* To demonstrate consistency of each intervention group with the corresponding historical control study results.
* To demonstrate that comparable clinical outcomes can be achieved for each intervention group.

Secondary:

• Change in clinical outcomes compared to baseline.

Eligibility criteria: Inclusion Criteria:

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 Criteria:

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 Exclusion Criteria:

Subjects will not be randomized and will be terminated from the study if they meet ANY of the following individual intra-operative exclusion criteria:

* Rotator cuff is/presents with:

  * Fully reparable with adequate tissue and muscle quality (equivalent to Goutallier stage 1 or 2)
  * Partial thickness tear of the supraspinatus
  * Evidence of significant osteoarthritis
* The subject requires concomitant:

  * Subscapularis repair
  * Labral repair of any type
  * Biceps tenodesis
* Coracoacromial ligament functional deficiency or shoulder instability is identified

Primary outcomes:
measure: Change in American Shoulder and Elbow (ASES) Score
timeFrame: Day 0 through Month 12
Secondary outcomes:
measure: Safety Assessment
timeFrame: Day 0 through Month 24
measure: Change in Western Ontario Rotator Cuff (WORC) Score
timeFrame: Day 0 through Month 24
measure: Change in Constant Score (CS) Outcome Score
timeFrame: Day 0 through Month 24
measure: Change in EuroQol 5-Dimensions Questionnaire (EQ-5D-5L) Score
timeFrame: Day 0 through Month 24
measure: Change in Visual Analog Scale (VAS) Score
timeFrame: Day 0 through Month 24
measure: Change in Range of Motion (ROM) Score
timeFrame: Day 0 through Month 24
measure: Change in Single Assessment Numeric Evaluation (SANE) Score
timeFrame: Day 0 through Month 24
measure: Patient's satisfaction with their procedure
timeFrame: Month 12 and Month 24
measure: Costing
timeFrame: Day 0 through Month 24
measure: Time to Recovery
timeFrame: Day 0 through Month 24
measure: Analgesia Use
timeFrame: Day 0 through Month 24
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Musculoskeletal-Orthopedic Research and Education Foundation
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Englewood
country: United States
facility: Steadman Hawkins Clinic Denver
state: Colorado
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital
state: Florida
city: West Palm Beach
country: United States
facility: Paley Orthopaedics & Spine
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Philadelphia
country: United States
facility: The Rothman Institute
state: Pennsylvania
city: San Antonio
country: United States
facility: TSAOG Orthopaedics & Spine
state: Texas
Study officials:
affiliation: Stryker Endoscopy
name: Colleen Roden, MS
role: STUDY_DIRECTOR
References: