ROTATOR CUFF - PDF Document

Presentation Transcript

  1. What is expected of me in this clinical research study? About the Sponsor Ortho-Space Ltd. is a medical device company that manufactures the The clinical research study requires investigational device, InSpace™. six (6) post-operative visits to the The InSpace system was CE (Conformité clinic over a period of 24 months (2 Européenne, 2011) marked in July 2010 and years). You will have a shoulder is available for use throughout Europe. assessment and you will be asked to Since its approval, more than three (3) complete quality of life questionnaires. thousand (3000) InSpace devices have At no additional cost, you will be been implanted into patients with a similar required to have one (1) MRI of your shoulder problem as you. shoulder at 12 months (1 year). You may also be required to have three (3) For more information please contact: Uma Srikumaran Ultrasound tests during the first three (3) months of the clinical research study. Surgeon Name: Casey Hannan Clinical Research Staff: Do I have to participate in research? ROTATOR CUFF 443-546-1555 Phone: [Telephone] channan1@jhmi.edu No. Research participation is strictly CLINICAL RESEARCH STUDY Email: [Email address] voluntary. Your decision to participate, PI: Uma Srikumaran Application #: IRB00070126 or not, will not affect your health care Clinical Research Study Registered at: www.clinicaltrials.gov treatment. ORTHO-SPACE Ltd. Web: www.orthospace.co.il CLPR15021551_rev 01

  2. To qualify for this clinical research study, you must: What is this clinical research study about? Your doctor is conducting a clinical research study to evaluate a new Be 40 years of age or over and in general good health investigational device for arthroscopic treatment of massive rotator cuff tears Experiencing persisting shoulder pain for at least four (4) months which failed non-operative treatments such as: in the shoulder. InSpace™ Investigational Device Information If you choose to take part and qualify ? Physical therapy for the clinical research study, you will ? Investigational devices have not been Activity modification be randomly assigned (like flipping a ? approved by the U.S. Food and Drug Rest (sling) coin). You will have a 50% chance of ? Administration (FDA) for commercial Anti-inflammatory medication receiving the investigational device. use, but have been approved for use in a You will not know which treatment you Have had an MRI within 9 months that confirms a full thickness rotator cuff tear clinical research study. receive until the clinical research study The InSpace device is a balloon shaped is completed. Fulfil all study criteria as assessed by your surgeon and be willing to return for all follow-up visits implant made from a polymer, which is What are the costs of this clinical research study? widely used material in the medical industry. The material is biodegradable meaning that following surgery it will What are the risks? gradually dissolve until it is completely If you have health insurance, there will The risks of this clinical research absorbed at approximately one year be no extra costs to you beyond the study are the same as those following the implantation. During this care you would normally receive to expected in any standard time, the device is intended to support treat your condition. The MRI and arthroscopic shoulder surgery. your shoulder healing allowing Ultrasounds required by the clinical There are additional risks that may frictionless gliding between the shoulder research study will be paid for by the be associated with the bones which may improve shoulder sponsor. investigational device. Speak with muscle activity. your doctor to understand the risks