NCT05329584招募中不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 21
- 主要终点
- Change in American Shoulder and Elbow (ASES) Score
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in American Shoulder and Elbow (ASES) Score
时间窗: 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).
次要结局
- 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)
研究者
研究点 (21)
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