此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

REGENETEN™ 生物感应植入系统在高级部分厚度撕裂中的使用 (IMPACT)

2026年9月23日 更新者：Smith & Nephew, Inc.

可吸收胶原植入物治疗高度部分厚度撕裂的安全性和有效性评估；前瞻性、多中心、随机、对照试验（IMPACT 研究）

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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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).

研究类型

介入性

注册 (估计的)

234

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 加拿大
    • Alberta
      • Calgary、Alberta、加拿大、T2R 2G5
        • 招聘中
        • Access Orthopaedics
        • 接触：
          • Kristie More
        • 首席研究员：
          • Ian Lo
    • Manitoba
      • Winnipeg、Manitoba、加拿大
        • 主动，不招人
        • Pan Am Clinic
    • Ontario
      • Hamilton、Ontario、加拿大
        • 招聘中
        • Research St. Joseph's
        • 首席研究员：
          • Moin Khan
        • 接触：
          • Danielle Dagher
  • 意大利
      • Milan、意大利
        • 招聘中
        • IRCCS Istituto Ortopedico Galeazzi,
        • 接触：
          • Vincenzo Guarrella
        • 首席研究员：
          • Ettore Taverna
      • Roma、意大利
        • 招聘中
        • Fondazione Policlinico Universitario Campus Bio-Medico
        • 接触：
          • Giuseppe Longo
        • 首席研究员：
          • Giuseppe Longo
  • 澳大利亚
    • Victoria
      • Richmond、Victoria、澳大利亚、3121
        • 招聘中
        • OrthoSport Victoria
        • 首席研究员：
          • Soong Chua
        • 接触：
          • Haydn Klemm
  • 美国
    • Georgia
      • Rome、Georgia、美国、30165
        • 招聘中
        • Harbin Clinic
        • 首席研究员：
          • Brandon Bushnell
        • 接触：
          • Terri Brannon
    • Illinois
      • Rockford、Illinois、美国、61107
        • 招聘中
        • OrthoIllinois LTD
        • 首席研究员：
          • Scott Trenhaile
        • 接触：
          • Catherine Ayala
    • Maryland
      • Baltimore、Maryland、美国、21215
        • 撤销
        • Sinai Hospital Baltimore
    • Ohio
      • Garfield Heights、Ohio、美国、44125
        • 撤销
        • Cleveland Clinic - Sports Health
    • Pennsylvania
      • Pittsburgh、Pennsylvania、美国、15213
        • 招聘中
        • University of Pittsburgh
        • 首席研究员：
          • Albert Lin
        • 接触：
          • Alec Howard
    • Texas
      • Bedford、Texas、美国、76021
        • 主动，不招人
        • Texas Orthopedic Specialists
      • The Woodlands、Texas、美国、77385
        • 撤销
        • Houston Methodist The Woodlands
    • Wisconsin
      • Ashland、Wisconsin、美国、54806
        • 撤销
        • Memorial Medical Center
  • 英国
      • Bath、英国
        • 招聘中
        • Sulis Hospital
        • 首席研究员：
          • Andrew Chambler
      • Bristol、英国
        • 招聘中
        • North Bristol NHS Trust
        • 接触：
          • Steven Barnfield
        • 首席研究员：
          • Iain Packham
      • Salford、英国、M6 8HD
        • 撤销
        • Northern Care Alliance NHS Foundation Trust
    • Surrey
      • Chertsey、Surrey、英国、KT16 0PZ
        • 招聘中
        • Ashford & St Peter's Hospitals NHS Foundation Trust
        • 首席研究员：
          • Ali Narvani
        • 接触：
          • Timnit Tekie
  • 西班牙
      • Madrid、西班牙、28034
        • 招聘中
        • Hospital Ramón y Cajal
        • 接触：
          • Miguel Angel Ruiz Iban
        • 首席研究员：
          • Miguel Angel Ruiz Iban
      • Madrid、西班牙、28040
        • 招聘中
        • Hospital Fundación Jiménez Díaz
        • 接触：
          • Cristina Delgado del Cano
        • 首席研究员：
          • Emilio Calvo

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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 3.55.
  • 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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Isolated Bioinductive Repair

Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
设备：Isolated Bioinductive Repair

Isolated Bioinductive repair with REGENETEN™ Bioinductive Implant

其他名称：
  • REGENETEN™ 生物感应植入物
有源比较器：Completion and Repair

Surgical treatment of partial-thickness rotator cuff tears using the standard surgical technique 'Completion and Repair'.
程序：Completion and Repair

Standard surgical repair using the 'Completion and Repair' technique.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Western Ontario Rotator Cuff (WORC)
大体时间：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).
Change from baseline to 3 months post-intervention

次要结果测量

结果测量
措施说明
大体时间
Western Ontario Rotator Cuff (WORC)
大体时间：Pre-op, 6 weeks, 3, 6, 12 and 24 months

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).
Pre-op, 6 weeks, 3, 6, 12 and 24 months
Constant-Murley Score
大体时间：Pre-Op, 3, 6, 12 and 24 months

The Constant-Murley Score is a validated assessment of pain and shoulder functionality. The Constant Score is divided into 4 subscales: pain (15 points; VAS score range of 0-15), activities of daily living (20 points; range 0=worst, 5=best), strength (25 points; 1 point given per 0.5 kg of weights raised), and range of motion - forward flexion, external rotation, abduction and internal rotation of the shoulder (40 points; range 0=worst, 10=best). The higher the score, the higher the quality of function.
Pre-Op, 3, 6, 12 and 24 months
Subjective Shoulder Value (SSV) score
大体时间：Pre-Op, 6 weeks, 3, 12 and 24 months

The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100% (0% to 100% scale with 100% being normal).
Pre-Op, 6 weeks, 3, 12 and 24 months
EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS & index scores
大体时间：Pre-Op, 3 and 6 weeks, 3, 6, 12 and 24 months

To assess the subject's health state. The EQ-5D-5L is composed of the EQ- 5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS).

The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded as single-digit numbers expressing the severity level selected in each dimension. For instance, 'slight problems' (e.g. 'I have slight problems in walking about') is always coded as '2'. The digits for the five dimensions are combined in a 5-digit code. The EQ- 5D-5L index value is derived by using the vendor supplied calculator to convert each 5-digit EQ- 5D-5L profile.

The EQ VAS corresponds to a 20 cm vertical, visual analogue scale ranging from 'the best health you can imagine' to 'the worst health you can imagine'.

A higher number is a better outcome.
Pre-Op, 3 and 6 weeks, 3, 6, 12 and 24 months
Change in Western Ontario Rotator Cuff (WORC)
大体时间：Change from Pre-op to 6 weeks, 3, 6, 12 and 24 months

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).
Change from Pre-op to 6 weeks, 3, 6, 12 and 24 months
Change in Constant-Murley Score
大体时间：Change from Pre-Op to 6 weeks, 3, 12 and 24 months

The Constant-Murley Score is a validated assessment of pain and shoulder functionality. The Constant Score is divided into 4 subscales: pain (15 points; VAS score range of 0-15), activities of daily living (20 points; range 0=worst, 5=best), strength (25 points; 1 point given per 0.5 kg of weights raised), and range of motion - forward flexion, external rotation, abduction and internal rotation of the shoulder (40 points; range 0=worst, 10=best). The higher the score, the higher the quality of function.
Change from Pre-Op to 6 weeks, 3, 12 and 24 months
Change in Subjective Shoulder Value (SSV) score
大体时间：Change from Pre-Op to 6 weeks, 3, 12 and 24 months

The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100% (0% to 100% scale with 100% being normal).
Change from Pre-Op to 6 weeks, 3, 12 and 24 months
Percent Achieving Minimal Clinically Important Difference (MCID) for Constant-Murley Score
大体时间：Pre-Op, 3, 6, 12 and 24 months

The Constant-Murley Score is a validated assessment of pain and shoulder functionality. The Constant Score is divided into 4 subscales: pain (15 points; VAS score range of 0-15), activities of daily living (20 points; range 0=worst, 5=best), strength (25 points; 1 point given per 0.5 kg of weights raised), and range of motion - forward flexion, external rotation, abduction and internal rotation of the shoulder (40 points; range 0=worst, 10=best). The higher the score, the higher the quality of function.
Pre-Op, 3, 6, 12 and 24 months
Percent Achieving MCID for Western Ontario Rotator Cuff (WORC)
大体时间：Pre-op, 6 weeks, 3, 6, 12 and 24 months

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).
Pre-op, 6 weeks, 3, 6, 12 and 24 months
Percent Achieving MCID for Subjective Shoulder Value (SSV) score
大体时间：Pre-Op, 6 weeks, 3, 12 and 24 months

The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100% (0% to 100% scale with 100% being normal).
Pre-Op, 6 weeks, 3, 12 and 24 months
Patient Satisfaction
大体时间：6 weeks, 3, 6, 12 and 24 months

Comprise of 2 questions:

  1. Overall, I am satisfied with the outcome of my surgery
  2. I would recommend the procedure to a friend.

Question rated by the patient with Strongly Agree, Agree, Neither Agree nor Disagree, Disagree, Strongly Disagree.
6 weeks, 3, 6, 12 and 24 months
Pain, Visual analog scale (VAS) Score
大体时间：Pre-Op, 3 and 6 weeks, 3, 12 and 24 months

Pain is assessed on a 100-point scale ranging from 0 to 100, with zero (0) representing no pain and 100 representing the worst pain imaginable.
Pre-Op, 3 and 6 weeks, 3, 12 and 24 months
MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via Sugaya Score
大体时间：12 months

The Sugaya score is classified into 5 categories: Type I to Type V. Type I indicates sufficient thickness with homogenously low intensity. Type II indicates sufficient thickness with partial high intensity. Type III indicates insufficient thickness without discontinuity. Type IV indicates presence of a minor discontinuity, suggesting a small full-thickness tear. Type V indicates the presence of a major discontinuity, suggesting a medium or large full-thickness tear.
12 months
MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via MRI assessment of percent filling
大体时间：12 months

Percent tissue infil is graded at site of original tear and classified as 0% to < 25%, 25% to < 50%, 50% to < 75%, 75% to < 100% and 100%.
12 months
MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via MRI assessment of the signal intensity pattern
大体时间：12 months

The Signal Intensity Pattern will be graded into 3 categories. Type I: Heterogeneous high signal intensity with fluid-like bright foci, Type II: Heterogeneous high signal intensity without fluid-like bright foci, Type III: Heterogeneous or homogeneous low signal intensity.
12 months
MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via Rotator cuff tendon thickness
大体时间：12 months

Tendon thickness will be measured in millimeters (mm).
12 months
MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via Goutallier classification
大体时间：12 months

The Goutallier classification will be used to classify the fatty infiltration of the rotator cuff. The Goutallier classification ranges from a grade of 0 indicating a completely normal muscles without any fatty streaks to a grade of 4 which indicates that more fat than muscle is present.
12 months
Incidence of Revision Surgery
大体时间：1, 3 and 6 weeks, 3, 6, 12 and 24 months

Number of subjects requiring revision surgery
1, 3 and 6 weeks, 3, 6, 12 and 24 months
Time to return to work
大体时间：Up to 24 months

Number of weeks taken to return to work following surgery
Up to 24 months
Time to return to driving
大体时间：Up to 24 months

Number of weeks taken to return to driving following surgery
Up to 24 months
Time to return to sports
大体时间：Up to 24 months

Number of weeks taken to return to sport following surgery
Up to 24 months
Total operative time
大体时间：Inter-operative time

Time expressed in minutes
Inter-operative time
Physical Therapy Utilization
大体时间：Up to 24 months

Number visits following index surgery
Up to 24 months
Cumulative days of opioid use
大体时间：Day 1-14

Self-reported opioid use diary completed by the patient on a daily basis, from day 0-14, documenting opioid use. Consumption daily (YES/NO) x14 days, 'Have you taken any opioid medication today for shoulder pain?'
Day 1-14
Duration of shoulder immobilization following index surgery
大体时间：1, 3 and 6 weeks, 3 months

Number of days
1, 3 and 6 weeks, 3 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Smith & Nephew, Inc.

调查人员

  • 学习椅：Laura Mills、Smith & Nephew, Inc.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2022年8月30日

初级完成 (估计的)

2027年4月15日

研究完成 (估计的)

2029年2月28日

研究注册日期

首次提交

2022年6月29日

首先提交符合 QC 标准的

2022年6月29日

首次发布 (实际的)

2022年7月6日

研究记录更新

最后更新发布 (实际的)

2026年9月28日

上次提交的符合 QC 标准的更新

2026年9月23日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • REGENETEN.2021.04

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅