InSpace Accelerated Rehabilitation Study (iAccelerate)

Stryker

Status: Enrolling

Conditions: Rotator Cuff Tears

Treatments: Device: InSpace Subacromial Tissue Spacer

Study type: Interventional

Funder types: Industry

Identifiers

NCT05329584

SYK-SM-2021-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Group I

Experimental group

Description:

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

Treatment:

Device: InSpace Subacromial Tissue Spacer

Group II

Experimental group

Description:

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

Treatment:

Device: InSpace Subacromial Tissue Spacer