A randomized, two-arm, prospective, subject blind study to assess the safety and efficacy of InSpace* device in comparison to full thickness massive rotator cuff repair in subjects scheduled for a repair surgery. - InSpace* in Comparison to Best Repair of Massive Rotator Cuff Tear.

OrthoSpace LTD.0 个研究点目标入组 40 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

阶段: 4 期
状态: 撤回
发起方
入组人数: 40

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 99（—）

入选标准

•-Male or female age 40 or older
•-Positive diagnostic imaging (based on MRI within 9 months of consent date) of the affected shoulder indicating full thickness Massive RCT of at least 5cm in diameter (according to Cofield classification) or long - narrow tears of at least 4cm2 (W>2cm and L>2cm) including fatty infiltration grade III or IV (according to classification of Goutallier) involving more than one tendon
•-Persistent pain of the affected shoulder for at least 3 months with no response to conservative treatment (such as physical therapy, pain relief medication, local steroid injection etc.)
•-Mentally and physically able to fully comply with the protocol procedures including adherence to follow-up schedule and completion of the required subject*s questionnaires.
•-Willing to undergo video/photographic documentation of affected shoulder during shoulder evaluation

排除标准

•-Known allergy to the device material (copolymer of PLA and -*-caprolactone)
•- Evidence of severe osteoarthritis, arthropathy or cartilage damage of the shoulder with loss of passive gleno-humarel joint range of motion
•- Evidence of gleno-humeral instability
•-Previous surgery of the shoulder in the past 2 years, excluding diagnostic arthroscopy
•-Evidence of major joint trauma, infection, or necrosis in the shoulder
•-Partial-thickness tears of the rotator cuff
•-Unable to provide informed consent or complete required questionnaires due to language barrier or mental status
•-Major medical condition that could affect quality of life and influence the results of the study (i.e: HIV or other immunosuppressive conditions, active malignancy in the past 5 years, acute MI, CVA etc.)
•-Documented or known drug or alcohol abuses that could affect quality of life and influence the results of the study
•-Unwilling to be followed for the entire duration of the study
•-Subjects with worker compensation claims or other litigation claims related to the shoulder being treated in the study
•-Females of child-bearing potential who are pregnant or breastfeeding, or plan to become pregnant during the course of the study
•-Concurrent participation in any other invasive clinical study one month prior to enrollment to the study and during the entire study period.
•-The subject has implanted metallic devices (cardiac pacemakers, insulin pumps, and nerve stimulators), medically implanted clips or other electronically, magnetically or mechanically activated implants that would contraindicate undergoing an MRI scan of the shoulder
•-The subject has claustrophobia that would inhibit their ability to undergo an MRI scan of the shoulder
•-The subject has known allergy to the required pre-operative broad spectrum antibiotic.

研究者

发起方

OrthoSpace LTD.

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