Pre-market Clinical Investigation Inovedis SINEFIX
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Functional and clinical outcome after rotator cuff repair as compared with baseline
研究概览
简要总结
Shoulder pain is one of the most commonly reported musculoskeletal complaints, which negatively affects upper limb use, night rest, daily life activities, work, sports performance and autonomy. Rotator cuff disease represents the most common cause of shoulder pain and it is responsible for up to 70% of all shoulder related visits to clinicians. Its incidence furthermore is expected to grow as the population ages. A wide range of conditions are included under the umbrella term of rotator cuff disease, including rotator cuff tendinopathy, subacromial bursal pathology, and partial-thickness or full- thickness rotator cuff tears (RCTs). The latter ones, i.e. rotator cuff tears, form the indications for which the test devices, the SINEFIX implant and instruments, are intended.
Despite the high prevalence of this condition, the pathophysiology and healing potential are not well understood, making the condition challenging to predictably treat in some patient populations. RCTs may occur in young people as a consequence of trauma (e.g. acute shoulder dislocation), however RCTs typically present in middle-aged or elderly people and cannot always be attributed to precipitating events or trauma. Instead, they can be attributed to degenerative processes, and are therefore referred to as degenerative RCTs.
For RCTs, treatment options include both surgical and non-surgical (conservative) procedures.
In this context, the SINEFIX implant and instruments were developed to treat adult patients with rotator cuff lesions of size up to 2 cm through arthroscopic reconstruction.
A pilot study phase investigating the SINEFIX implant and instruments was conducted and showed adequate performance, usability and preliminary safety. Hence, the device is now being tested on a larger number of participants as part of the comparative study phase.
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
- Double (Participant, Outcomes Assessor)
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
- •Patient indicated for surgical repair of the rotator cuff tear according to current guidelines
- •Patient aged 18 years or older
- •Up to 2 cm tear size (medio-lateral) of supraspinatus, infraspinatus
- •Up to 2 cm tear size (anterior-posterior) of supraspinatus, infraspinatus
排除标准
- •Subject has had previous rotator cuff, arthroplasty or fracture procedures on the operative shoulder
- •History of alcoholism, drug abuse, psychological or other emotional problems likely to interfere with participation in the study follow-up schedule and assessments
- •Inflammatory arthropathies
- •Subject with a contraindication/non-compliance for MRI examination
- •Subject 's unwillingness to undergo surgical rotator cuff repair, participate in post-operative rehabilitation program, and / or adhere to follow up schedule
- •Pregnant and breastfeeding woman
研究组 & 干预措施
SINEFIX
Rotator cuff repair with the SINEFIX implant, using the SINEFIX instruments
干预措施: Rotator cuff repair with the SINEFIX (Device)
Comparator
Rotator cuff repair with the conventional surgical technique (comparator device)
干预措施: Rotator cuff repair with comparator device (Device)
结局指标
主要结局
Functional and clinical outcome after rotator cuff repair as compared with baseline
时间窗: 1 year post operation
Functional and clinical outcome after rotator cuff repair will be assessed using the increase in total Constant Murley score at 1 year follow-up compared with baseline (range 0 (worst outcome) -100 (best outcome))
次要结局
- Patient satisfaction(At 10 weeks, 6, 12, 24 months)
- Healing integrity(At 6, 12, and 24 months)
- Functional and clinical outcome after rotator cuff repair(At 6 months, 1 and 2 years follow-up)
- Functional and clinical outcome after rotator cuff repair as compared with baseline(At 6 months and 2 years follow-up)
- Shoulder function after rotator cuff repair (subjective evaluation)(At 10 weeks, 6, 12, and 24 months)
- Surgery time(Immediately post procedure)
- Shoulder function after rotator cuff repair (physical examination-active external rotation)(At 10 weeks, 6, 12, and 24 months)
- Dislocation of the implant(At 6, 12, and 24 months)
- Bursitis(At 6, 12, and 24 months)
- Shoulder function after rotator cuff repair (physical examination-active anteversion)(At 10 weeks, 6, 12, and 24 months)
- Complications(During the follow up time (up to 24 months))
- Re-tear rate(At 6, 12, and 24 months)