NCT05444465招募中不适用
Evaluation of Safety and Efficacy of a Resorbable Collagen Implant in Treatment of High Grade PArtial ThiCkness Tears; A Prospective, Multicenter, Randomized, Control Trial (IMPACT Study)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 234
- 试验地点
- 35
- 主要终点
- Change in Western Ontario Rotator Cuff (WORC)
研究概览
简要总结
The purpose of the study is to assess whether the REGENETEN™ Bioinductive Implant allows patients to get back to their everyday activities quicker than if the tendon is repaired by the standard repair technique 'Completion and Repair' for surgically treating partial-thickness rotator cuff tears.
详细描述
The primary objective of this study is to evaluate the functional recovery of patients with high grade (>50%) partial thickness tears at 3 months when treated with either Isolated Bioinductive Repair (IBR) or Completion and Repair (CAR).
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject must provide written informed consent.
- •Subject is > eighteen (18) years of age (no upper limit).
- •Subject has an isolated high-grade (>50% or >6mm) (Ellman grade III) partial thickness tear of supraspinatus or supraspinatus with infraspinatus.
- •Subject has failed a minimum of 3 months of conservative management for treatment of partial thickness rotator cuff tear.
- •Subject willing and able to make all required study visits.
- •Subject able to follow instructions and deemed capable of completing all study questionnaires.
排除标准
- •Subjects with insufficient tendon tissue quality for management and protection of the tendon injury using the isolated REGENETEN Bioinductive Implant system.
- •Subjects where the prescribed Physical Therapy guidelines stated in the protocol are not suitable for their rehabilitation.
- •Subjects with Samilson-Prieto osteoarthritis grade 2 and greater.
- •Subjects with current or prior infection of the ipsilateral shoulder.
- •Subjects with known hypersensitivity to bovine-derived materials.
- •Subjects with known inflammatory arthropathy, history of inflammatory arthropathy, chronic joint disease or chronic pain of upper extremities (shoulder(s), arm(s)).
- •Subjects with prior shoulder surgery on index shoulder, including subacromial decompression, biceps tenodesis/tenotomy, and acromioclavicular joint (ACJ) excision/distal clavicle excision (DCE).
- •Subjects with a planned surgery on the contra-lateral shoulder within the study period.
- •Systemic steroid use (oral, IV) or local steroid injection within 3 months of the date of surgery.
- •Subjects with a full thickness rotator cuff tear.
- •Subjects with a subscapularis tear requiring repair.
- •Subjects requiring a concomitant labral fixation procedure, concomitant surgery for bone defects requiring bone implantation or for superior labral tear from anterior to posterior (SLAP).
- •Subjects requiring a concomitant os acromiale fixation procedure.
- •Subjects with glenohumeral joint instability (multiple dislocations/subluxations).
- •Subjects with condition(s) that contraindicate or complicate outcomes of Isolated Bioinductive Repair or completion and repair e.g., > Hamada 3 rotator cuff arthropathy on X-ray, Goutallier atrophy > Grade 3, proximal humeral fracture or scapular fracture, avascular necrosis of the humeral head.
- •Subjects with neurologic conditions effecting either upper extremity.
- •Subjects who are unable to tolerate magnetic resonance imaging (MRI), due to psychiatric or medical contraindications.
- •Subjects who are pregnant or breast feeding.
- •Subjects who are currently involved in any injury litigation relating to the index shoulder.
- •Subjects with current workers compensation claim.
- •Subjects who are enrolled, or plan to enroll, in another clinical trial during this study that would affect the outcomes of this study.
- •Subjects with a history of poor compliance with medical treatment, physical therapy (PT)/rehabilitation, or clinical study participation.
- •Subject who, in the opinion of the Investigator, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, and drug or alcohol abuse.
- •Subjects who do not meet the indication or are contraindicated according to specific Smith+Nephew REGENETEN System's Instructions for Use (IFUs).
- •Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.
- •Subjects who have participated previously in this clinical trial and who have healed or been withdrawn
- •Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.
研究组 & 干预措施
Completion and Repair
Active Comparator
Surgical treatment of partial-thickness rotator cuff tears using the standard surgical technique 'Completion and Repair'.
干预措施: Completion and Repair (Procedure)
Isolated Bioinductive Repair
Experimental
Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
干预措施: Isolated Bioinductive Repair (Device)
结局指标
主要结局
Change in Western Ontario Rotator Cuff (WORC)
时间窗: Change from baseline to 3 months post-intervention
The WORC Index is self-administered, and includes a 5 different domains (physical symptoms, sports and recreation, work, social function, and emotions). Each question uses a visual analog scale (VAS) representing a 100-point scale ranging from 0 to 100. The maximum score is 2100 (worst possible symptoms). Zero (0) represents no symptoms at all. The final score can also be presented as a percentage by subtracting the total from 2100, dividing by 2100, and multiplying by 100. This will give you an overall percentage. The total final WORC Index scores can, therefore, range from 0% (lowest functional status level) to 100% (highest functional status level).
次要结局
- Change in Subjective Shoulder Value (SSV) score(Change from Pre-Op to 6 weeks, 3, 12 and 24 months)
- Subjective Shoulder Value (SSV) score(Pre-Op, 6 weeks, 3, 12 and 24 months)
- Change in Constant-Murley Score(Change from Pre-Op to 6 weeks, 3, 12 and 24 months)
- Physical Therapy Utilization(Up to 24 months)
- Change in Western Ontario Rotator Cuff (WORC)(Change from Pre-op to 6 weeks, 3, 6, 12 and 24 months)
- Western Ontario Rotator Cuff (WORC)(Pre-op, 6 weeks, 3, 6, 12 and 24 months)
- Constant-Murley Score(Pre-Op, 3, 6, 12 and 24 months)
- Percent Achieving MCID for Subjective Shoulder Value (SSV) score(Pre-Op, 6 weeks, 3, 12 and 24 months)
- MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via Sugaya Score(12 months)
- MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via Goutallier classification(12 months)
- Incidence of Revision Surgery(1, 3 and 6 weeks, 3, 6, 12 and 24 months)
- Total operative time(Inter-operative time)
- Duration of shoulder immobilization following index surgery(1, 3 and 6 weeks, 3 months)
- EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS & index scores(Pre-Op, 3 and 6 weeks, 3, 6, 12 and 24 months)
- MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via MRI assessment of the signal intensity pattern(12 months)
- Time to return to sports(Up to 24 months)
- Cumulative days of opioid use(Day 1-14)
- Patient Satisfaction(6 weeks, 3, 6, 12 and 24 months)
- Pain, Visual analog scale (VAS) Score(Pre-Op, 3 and 6 weeks, 3, 12 and 24 months)
- Time to return to work(Up to 24 months)
- Percent Achieving Minimal Clinically Important Difference (MCID) for Constant-Murley Score(Pre-Op, 3, 6, 12 and 24 months)
- Percent Achieving MCID for Western Ontario Rotator Cuff (WORC)(Pre-op, 6 weeks, 3, 6, 12 and 24 months)
- MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via MRI assessment of percent filling(12 months)
- MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via Rotator cuff tendon thickness(12 months)
- Time to return to driving(Up to 24 months)
研究者
研究点 (35)
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