A Pivotal Study to Assess the InSpace™ Device for Treatment of Full Thickness Massive Rotator Cuff Tears
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| ClinicalTrials.gov Identifier: NCT02493660 |
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Recruitment Status :
Active, not recruiting
First Posted : July 9, 2015
Last Update Posted : August 28, 2019
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Sponsor:
OrthoSpace Ltd.
Information provided by (Responsible Party):
OrthoSpace Ltd.
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Brief Summary:
A pivotal study to assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical repair of full thickness Massive Rotator Cuff Tear (MRCT).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Rotator Cuff Syndrome | Device: InSpace sub-acromial tissue spacer system Procedure: Partial repair of rotator cuff | Not Applicable |
This is a non-inferiority, prospective, single blinded, multi-center, randomized, controlled, pivotal study evaluating the safety and effectiveness of the InSpace™ device as a primary surgical treatment for full thickness MRCT in comparison to Partial Repair of a full thickness MRCT performed during an arthroscopic procedure.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 184 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Treatment |
| Official Title: | A Prospective, Single Blinded, Multi-center, Randomized, Controlled, Pivotal Study to Assess the Safety and Effectiveness of the InSpace™ Device for Treatment of Full Thickness Massive Rotator Cuff Tears |
| Actual Study Start Date : | June 26, 2015 |
| Actual Primary Completion Date : | June 2019 |
| Estimated Study Completion Date : | April 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: InSpace implantation
Arthroscopic InSpace (Sub-acromial tissue spacer system) implantation
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Device: InSpace sub-acromial tissue spacer system
Arthroscopic implantation of InSpace sub-acromial tissue spacer system |
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Active Comparator: Tendon Repair
Arthroscopic partial repair of rotator cuff
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Procedure: Partial repair of rotator cuff
Arthroscopic partial repair of rotator cuff |
Primary Outcome Measures :
- Evaluate the safety as measured by adverse events frequency to study treatment and control treatment [ Time Frame: At each follow up visit up to 2 years post operation ]To evaluate the safety of the InSpace device as a primary surgical treatment for full thickness massive rotator cuff tears
- Change in Western Ontario Rotator Cuff Index (WORC) compared to baseline [ Time Frame: 12 months post operation ]An improvement in WORC scores at 12 month post-operation compared to baseline
Secondary Outcome Measures :
- Change in American Shoulder and Elbow Surgeons (ASES) score [ Time Frame: Up to 2 years post operation ]Change in ASES from baseline shoulder scores from baseline to each follow-up visit
- Change in Constant shoulder outcome score [ Time Frame: Up to 2 years post operation ]Change in Constant shoulder scores from baseline to each follow-up visit
- Change in Quality of Life compared to baseline [ Time Frame: Up to 2 years post operation ]Change in EuroQOL(EQ-5D-5L) five dimensions questionnaire from baseline to each follow-up visit
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| Ages Eligible for Study: | 40 Years to 100 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Main Inclusion Criteria:
- Positive diagnostic imaging by MRI of the index shoulder indicating a full thickness Massive Rotator Cuff Tear (MRCT), measuring ≥ 5 cm in diameter involving ≥ two tendons (confirmed Intra-operatively)
- Functional deltoid muscle and preserved passive range of motion on physical examination
- Documented VAS score of > 30 mm pain
- Failed non-operative treatment of at least 4 months
- Patient in general good health,independent, and can comply with all post-operative evaluations and visits.
Main Exclusion Criteria:
- Known allergy to the device material (copolymer of PLA and -ε-caprolactone)
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Evidence of the following conditions:
- significant gleno-humeral or acromiohumeral arthritis
- full thickness cartilage loss as seen on MRI
- gleno-humeral instability (excessive translation of the humeral head on the glenoid fossa)
- pre-existing deltoid defect or deltoid palsy
- major joint trauma, infection or necrosis
- partial thickness tears of the supraspinatous
- fully reparable rotator cuff tear [Tear of less than 5 cm in diameter (or < 4 cm2) with retractable tendon that can be fully repaired]
- The subject requires concomitant subscapularis repair and/or labral repair
- Previous surgery of the index shoulder in the past 1 year, excluding diagnostic arthroscopy
- The subject's condition is bilateral and rotator cuff repair is scheduled or to be scheduled over the course of this study for the contra lateral shoulder
- Major medical condition that could affect quality of life and influence the results of the study (e.g. HIV or other immunosuppressive conditions, active malignancy in the past 5 years, acute MI, CVA, etc.)
- Documented evidence of a history of drug/alcohol abuse within 12 months of enrollment
- The subject's condition represents a worker's compensation case
- The subject is currently involved in a health-related litigation procedure
- 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 investigational clinical study one month prior to enrollment or during the entire study period
- The subject has implanted metallic devices (e.g., cardiac pacemakers, insulin pumps, nerve stimulators), medically implanted clips or other electronically, magnetically or mechanically activated implants that would contraindicate undergoing a MRI scan or has claustrophobia that would inhibit ability to undergo a MRI scan .
- The subject is physically or mentally compromised (e.g., currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.), to the extent that the Investigator judges the subject to be unable or unlikely to remain compliant to follow-up
- The subject is receiving prescription narcotic pain medication for conditions unrelated to the index shoulder condition
- The subject currently has an acute infection in the area surrounding the surgical site.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02493660
Locations
Show 21 study locations
Sponsors and Collaborators
OrthoSpace Ltd.
Investigators
| Study Director: | Assaf Dekel, MD | Ortho-Space |
| Responsible Party: | OrthoSpace Ltd. |
| ClinicalTrials.gov Identifier: | NCT02493660 |
| Other Study ID Numbers: |
CLD-OR-010 |
| First Posted: | July 9, 2015 Key Record Dates |
| Last Update Posted: | August 28, 2019 |
| Last Verified: | August 2019 |
Keywords provided by OrthoSpace Ltd.:
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Massive Rotator Cuff Tear Arthroscopy Shoulder Joint Rotator cuff partial repair |
Additional relevant MeSH terms:
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Rotator Cuff Injuries Rupture Wounds and Injuries Shoulder Injuries Tendon Injuries |