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.
- Conditions
- 10028302massive rotator cuff tearsrupture of the muscles around the shoulder
- Registration Number
- NL-OMON40993
- Lead Sponsor
- OrthoSpace LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 40
-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
-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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary efficacy outcome of the study is considered as the subject response<br /><br>rate at 6 month post-surgery or device implantation.<br /><br>Subject will be defined as responder if improvement of at least 10 points of<br /><br>the total score from baseline (pre-operation) to 6 month follow up visit of at<br /><br>least one of the shoulder assessment outcome scores (ASES, Constant) is<br /><br>observed. </p><br>
- Secondary Outcome Measures
Name Time Method