One-arm, International, Multi-center With Competitive Recruitment, Prospective Study to Assess the Safety and Efficacy of OrthoSpace's InSpace™ in Rotator Cuff Tear Subjects Scheduled for Surgery of the Rotator Cuff
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- The study's primary goal is to assess the safety of the SpaceGuard and implantation procedure, in the study population. Safety of the SpaceGuard will be assessed by reporting system related adverse events.
研究概览
简要总结
Title: One-arm, international, multi-center with competitive recruitment, prospective study to assess the safety and efficacy of OrthoSpace's InSpace™ in rotator cuff tear subjects scheduled for surgery of the rotator cuff - A pivotal study
Device: OrthoSpace's Biodegradable Implanted Balloon (InSpace)
Study population: Rotator Cuff tear subjects scheduled for arthroscopy.
Number of subjects: Up to 70 subject for data analysis.
Number of sites: At least 4 sites in Israel.
Main Inclusion criteria: Informed consent, diagnosed with Rotator Cuff tear.
Main Exclusion criteria: Former surgery on affected shoulder, sever illness, significant shoulder co morbidities.
Follow up period: 12 months. Visits at hospital before discharge at 1-2 days post implantation, 7-10 days post implantation, 3 weeks post implantation, 6 weeks post implantation, 3,6 and 12 months post implantation.
Primary goal: To assess the safety of the SpaceGuard in Rotator Cuff tear subjects.
Secondary goals: To assess the effectiveness of the SpaceGuard in the study population. The effectiveness will be assessed by terms of good positioning of the SpaceGuard and subsequent follow-up non migration, surgeon satisfaction, pain relief and time to pain relief, Range of Motion (ROM) and time to ROM with the SpaceGuard.
Primary end point: Serious Adverse Event rate related to the device and/or system complication.
Secondary end points: Surgeon dissatisfaction following the deployment of SpaceGuard, migration of the balloon shown by ultrasound/ X-ray/MRI at relevant follow-up visits, lost of ROM and pain enhancement.
详细描述
The OrthoSpace's InSpace™ biodegradable sub-acromial spacer (balloon) will be inserted at the end of the routine arthroscopy between the humerus head and the acromion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age 18 or older.
- •Diagnosed with Rotator Cuff tear and are scheduled for surgery.
- •X-Ray of treated shoulder with no unrelated pathology and imaging (ultrasound or MRI) showing Rotator Cuff tear.
- •Persistent pain and functional disability for at least 4 months.
- •Documented failure of conservative treatment.
- •Blood work up to two weeks before implantation as follow:
- •Normal CBC
- •Normal electrolytes (potassium, chloride, phosphorous, sodium)
- •Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3
- •Platelets ≥ 100,000 cells/mm3
- •Hemoglobin ≥ 10.0 g/dl
- •Adequate renal function, with serum creatinine ≤ 2.0 mg/dl
- •Adequate liver function, with serum bilirubin < 2.0 mg/dl
- •Adequate liver function with SGOT/SGPT < 2.5 x the upper normal limit
- •Normal values of the PT, PTT and INR tests
- •Negative for HIV and Hepatitis B or C
- •Mentally and physically able to fully comply with this protocol including adhering to follow-up schedule and requirements
- •For Woman of Child Bearing Potential (WOCBP), negative pregnancy test and willingness to use birth control during the study.
- •Singed Informed Consent Form.
排除标准
- •Evidence of significant osteoarthritis or cartilage damage in the shoulder.
- •Evidence of glenohumeral instability.
- •Previous surgeries of the shoulder .
- •Evidence of major joint trauma, infection, or necrosis in the shoulder.
- •Patients unable to provide informed consent due to language barrier or mental status.
- •Patients with a major medical condition that would affect quality of life and influence the results of the study (Including, but not limited to HIV, hepatitis, active malignancy in the past 5 years, transmural MI, CVA and other impaired neurological status, CHF or unstable angina in the past 6 months).
- •Patients unwilling to be followed for the duration of the study.
- •Acute infection requiring intravenous antibiotics at the time of screening.
- •Other shoulder pain of unknown etiology.
- •Paget's disease, osteomalacia or any other metabolic bone disease.
- •Severe diabetes mellitus requiring daily insulin management.
- •Bleeding disorders.
- •Known cognitive disorder.
- •Concurrent participation in any other clinical study.
- •Physician objection.
- •Subjects with sign of cervical root irritation.
- •Chronic lung disease
- •Trauma subjects
- •For WOCBP, a positive pregnancy test.
研究组 & 干预措施
SpaceGuard Balloon implantation
干预措施: SpaceGuard Balloon (Device)
结局指标
主要结局
The study's primary goal is to assess the safety of the SpaceGuard and implantation procedure, in the study population. Safety of the SpaceGuard will be assessed by reporting system related adverse events.
时间窗: 12-36 months follow-up
次要结局
未报告次要终点