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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Rotator Cuff Tears
- Sponsor
- Stryker Endoscopy
- Enrollment
- 160
- Locations
- 11
- Primary Endpoint
- Change in American Shoulder and Elbow (ASES) Score
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
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.
Investigators
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
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 \[Tear of less than 5 cm in diameter (or \< 4 cm2) with retractable tendon that can be fully repaired\]
Outcomes
Primary Outcomes
Change in American Shoulder and Elbow (ASES) Score
Time Frame: Day 0 through Month 12
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).
Secondary Outcomes
- Costing(Day 0 through Month 24)
- Time to Recovery(Day 0 through Month 24)
- Change in Visual Analog Scale (VAS) Score(Day 0 through Month 24)
- Change in Western Ontario Rotator Cuff (WORC) Score(Day 0 through Month 24)
- Change in EuroQol 5-Dimensions Questionnaire (EQ-5D-5L) Score(Day 0 through Month 24)
- Safety Assessment(Day 0 through Month 24)
- Change in Constant Score (CS) Outcome Score(Day 0 through Month 24)
- Change in Range of Motion (ROM) Score(Day 0 through Month 24)
- Change in Single Assessment Numeric Evaluation (SANE) Score(Day 0 through Month 24)
- Patient's satisfaction with their procedure(Month 12 and Month 24)
- Analgesia Use(Day 0 through Month 24)