Rotator Cuff Tendon Repair With FiberLocker System Patch Augmentation: A Prospective, Single-Arm, Non-Randomized, Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Total Number of Adverse Events (AEs)
研究概览
简要总结
The overall objective of this clinical investigation is to assess the safety and efficacy of full-thickness arthroscopic rotator cuff repairs augmented with the FiberLocker System for the subjects. The primary outcome of the investigation is to assess the safety after full-thickness arthroscopic rotator cuff repairs augmented with the FiberLocker System in terms of postoperative adverse events through the 12-month follow-up. Main secondary outcomes include measures of efficacy and clinical performance evaluated at 6-week, 4.5-month, and 12-month follow-ups including retear rate assessed using MRI and different functional performance scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject requires surgical treatment of a full-thickness rotator cuff tear, according to Balgrist standard procedure
- •Full-thickness tear of the supraspinatus or combined infraspinatus and supraspinatus
- •The rotator cuff tear is of traumatic origin.
- •Subject is ≥ 40 years of age & ≤ 65 years of age.
- •Primary rotator cuff repair
- •Informed Consent signed by the subject
- •Pre-operative MRI performed
排除标准
- •Vulnerable subjects (as defined in ISO 14155)
- •Subjects who do not have the power of judgement or are unable to fully understand all aspects of the investigation that are relevant to the decision to participate
- •Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation,
- •Previous enrolment into the current investigation,
- •Enrolment of the PI, his/her family members, employees and other dependent persons,
- •Inability to follow the procedures of the investigation, or known or suspected non-compliance, e.g. due to language problems, psychological disorders, dementia, drug or alcohol abuse, etc. of the subject
- •Active smoker
- •History of claustrophobia that would prevent an MRI of the index shoulder
- •Presence of an implanted metallic device or other implants that would contraindicate acquisition or inhibit radiologist review of an MRI of the index shoulder
- •Pregnant or planning to become pregnant during the study period
- •Breast feeding women
- •Subject has conditions or circumstances that would interfere with study requirements.
- •Contraindications and limitations of the MD as described in the IFUs.
- •Partial rotator cuff tears
- •History or known allergy or intolerance to polyester
- •Complete full-thickness subscapularis tears greater than the superior 1/3 of the tendon, with Lafosse grade 3 or greater
- •Massive rotator cuff tears, tear size equal to or greater than 4 cm in the anterior-posterior dimension or irreparable rotator cuff tear
- •Limited space or exposure for implant delivery
- •Structural or pathological condition of the bone or soft tissue that could impair healing.
- •Intraoperative rotator cuff tear characteristics differ from preoperatively expected characteristics and fulfil one of the abovementioned criteria
- •Fatty infiltration of the index shoulder rotator cuff muscle > Goutallier Score 2
- •Corticosteroid injection in the operative shoulder within 6 weeks of operation
- •Subject shows frozen shoulder/adhesive capsulitis at day of surgery
- •Cases of moderate to severe osteoarthritis
- •Patients with inflammatory disease or auto-immune based joint diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, arthropathy)
- •Subjects with diabetes type I or II
- •The subject currently has an acute infection in the area surrounding the surgical site
- •Evidence of active infection, osteomyelitis, sepsis or distant infection which could spread to the index joint.
- •Any comorbidity or condition that renders the patient a poor surgical candidate as determined by the Investigator.
研究组 & 干预措施
Augmentation of Rotator Cuff Repair using the FiberLocker System
All enrolled participants will undergo repair of the rotator cuff tear, with augmentation utilizing the FiberLocker System.
干预措施: FiberLocker® System (encompassing SpeedPatch® PET and FiberLocker Instrument® SN) (Device)
结局指标
主要结局
Total Number of Adverse Events (AEs)
时间窗: Surgery to 12-month follow-up
All operative and postoperative AEs will be recorded. Safety outcomes will be determined by evaluating the type, frequency, seriousness, and relationship to device or procedure of AEs for all subjects.
Total Number of Serious Adverse Events (SAEs)
时间窗: Surgery to 12-month follow-up
All operative and postoperative SAEs will be recorded. Safety outcomes will be determined by evaluating the type, frequency, and relationship to device or procedure of SAEs for all subjects.
Number of AE related to Device
时间窗: Surgery to 12-month follow-up
The operative and postoperative AEs that are related to the device will be reported. Safety outcomes will be determined by evaluating the type and frequency for all subjects.
Number of SAE related to Device
时间窗: Surgery to 12-month follow-up
The operative and postoperative SAEs that are related to the device will be reported. Safety outcomes will be determined by evaluating the type and frequency for all subjects.
Number of AE related to Procedure
时间窗: Surgery to 12-month follow-up
The operative and postoperative AEs that are related to the procedure will be reported. Safety outcomes will be determined by evaluating the type and frequency for all subjects.
Number of SAE related to Procedure
时间窗: Surgery to 12-month follow-up
The operative and postoperative SAEs that are related to the procedure will be reported. Safety outcomes will be determined by evaluating the type and frequency for all subjects.
次要结局
- Retear Rate(6-week, 4.5-month and 12-month follow-up)
- Constant-Murley Score(Baseline and 12-month follow-up)
- Visual Analog Scale for Pain (VAS)(Baseline, 2-week, 4.5-month and 12-month follow-up)
- Subjective Shoulder Value (SSV) Score(Baseline, 4.5-month and 12-month follow-up)
- EQ-5D-5L survey(Baseline, 4.5-month and 12-month follow-up)
- American Shoulder and Elbow Society (ASES) score(Baseline, 4.5-month and 12-month follow-up)
- Sugaya Classification(6-week, 4.5-month and 12-month follow-up)
- Goutallier Classification(Baseline, 6-week, 4.5-month and 12-month follow-up)
- Tendon Thickness(Baseline, 6-week, 4.5-month and 12-month follow-up)
- Fat Fraction of Muscle(Baseline, 6-week, 4.5-month and 12-month follow-up)