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 :
Completed
First Posted : July 9, 2015
Last Update Posted : June 24, 2020
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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) |
| Actual 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 : | March 6, 2019 |
| Actual Study Completion Date : | February 29, 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 :
- To evaluate the safety and effectiveness of the InSpace device as a primary surgical treatment for full-thickness massive rotator cuff tears. A composite endpoint requiring each of the following to be met to declare patient-level success [ Time Frame: At each follow up visit up to 1 years post operation ]WORC total score improvement of ≥275 points by Week 6 from pre-operative baseline and maintained at Month 12
- Composite endpoint for ASES scores [ Time Frame: At each follow up visit up to 1 years post operation ]ASES overall score improvement of ≥6.4 points by Week 6 from pre-operative baseline and maintained at Month 12;
- No subsequent secondary surgical interventions (SSSIs) in index shoulder [ Time Frame: Up to 2 years post operation ]No subsequent secondary surgical interventions ("SSSIs") in the index shoulder through Month 12;
- To have an absence of serious adverse device effects (SADEs) [ Time Frame: Up to 2 years post operation ]Absence of serious adverse device effects ("SADEs"), through Month 12.
Secondary Outcome Measures :
- Composite change in Western Ontario Rotator Cuff (WORC) score [ Time Frame: At each follow up visit up to 2 years post operation ]Composite endpoint component-level success for WORC total score compared to baseline;
- Composite change in American Shoulder and Elbow Surgeons (ASES) score [ Time Frame: At each follow up visit up to 2 years post operation ]Composite endpoint component-level success for ASES overall score compared to baseline
- Change in Western Ontario Rotator Cuff (WORC) score [ Time Frame: At each follow up visit up to 2 years post operation ]Change in WORC total score from baseline
- Change in American Shoulder and Elbow Surgeons (ASES) score [ Time Frame: At each follow up visit up to 2 years post operation ]Change in ASES overall score from baseline
- Change in Constant-Murley Shoulder Outcome score [ Time Frame: At each follow up visit up to 2 years post operation ]Change in Constant shoulder scores from baseline to each follow-up visit
- Change in Quality of Life (EQ-5D-6L) score [ Time Frame: At each follow up visit up to 2 years post operation ]Change in EuroQOL(EQ-5D-5L) five dimensions questionnaire from baseline to each follow-up visit
- Change in Visual analogue scale (VAS) [ Time Frame: At each follow up visit up to 2 years post operation ]Change in visual analogue scale ("VAS") pain score from baseline;
- Change in range of motion (ROM) (ASES) [ Time Frame: At each follow up visit up to 2 years post operation ]Change in range of motion ("ROM") (ASES Physician Assessment) from baseline.
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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: | June 24, 2020 |
| Last Verified: | March 2020 |
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 |