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
Results First Posted : July 22, 2021
Last Update Posted : June 15, 2022
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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 partial 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 : | February 29, 2020 |
| Actual Study Completion Date : | March 17, 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 :
- Percentage of Participants in the Per Protocol Population With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears From Baseline to Month 12 With no SSSIs and no SADEs. [ Time Frame: Baseline to month 12 ]
The primary composite effectiveness endpoint was defined as achievement of improvement for the Western Ontario Rotator Cuff (WORC) score (≥275 points) and American Shoulder and Elbow Society (ASES) score (≥6.4 points) by week 6 and maintenance at month 12 without subsequent secondary surgical intervention (SSSI) or serious adverse device effects (SADEs).
The improvement of points of the Western Ontario Rotator Cuff (WORC) of at least 275 (point scale of 0-2100:lower score is better) and American Shoulder and Elbow Society (ASES) at least 6.4 (point scale of 0-100:higher score is better) reflect the required number of points in improvement for treatment to be considered successful.
Secondary Outcome Measures :
- Composite Endpoint of WORC Improvement ≥275 and ASES Improvement ≥6.4 at Week 6 Maintained at Month 24 no Subsequent Secondary Surgical Intervention (SSSI) and no Serious Adverse Device Effect (SADEs) (Pre-specified). Composite WORC ASES and Safety to M24 [ Time Frame: Baseline through to Month 24 ]Composite Endpoint Per Protocol Population (PP) of WORC Improvement ≥ 275 and ASES Improvement ≥ 6.4 from baseline at Week 6 Maintained at Month 24 with no Subsequent Secondary Surgical Intervention (SSSI) and no Serious Adverse Device Effect (SADEs) (pre-specified).
- Composite Endpoint Component Level Success for WORC at Month 12 Compared to Baseline in the Per Protocol Population (PP) [ Time Frame: Baseline to month 12 ]The secondary effectiveness endpoint was defined as a composite component-level success at Month 12 for Western Ontario Rotator Cuff (WORC) total score improvement (≥275) (scale of 0-2100:lower score is better) in the two groups, InSpace and Partial Repair without subsequent secondary surgical intervention (SSSI) or serious adverse device effects (SADEs).
- Composite Endpoint Component Level Success for ASES at Month 12 Compared to Baseline in the Per Protocol Population (PP) [ Time Frame: Baseline to month 12 ]
The secondary endpoint was defined as a composite component-level success for American Shoulder and Elbow Surgeons ( ASES) compared at baseline to Month 12 without subsequent secondary surgical intervention (SSSI) or serious adverse device effects (SADEs)..
The total score improvement of (≥ 6.4 points) (scale of 0-100:higher score is better) from baseline in the two groups, InSpace and Partial Repair.
- Mean Change From Baseline to Month 24 in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears Through to Month 24. WORC [ Time Frame: Baseline through to month 24 ]The secondary effectiveness endpoint was defined as mean change from baseline to Month 24 for Western Ontario Rotator Cuff (WORC) total score improvement (≥275) (scale of 0-2100:lower score is better) in the two groups, InSpace and Partial Repair.
- Mean Change From Baseline to Month 24 in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears Through to Month 24. ASES [ Time Frame: Baseline through to month 24 ]
Mean change in American Shoulder and Elbow Surgeons (ASES) score from baseline to month 24.
The improvement of points of the American Shoulder and Elbow Society (ASES) at least 6.4 (point scale of 0-100:higher score is better) reflect the required number of points in improvement for treatment to be considered successful.
- Mean Change From Baseline to Month 24 for Constant-Murley (CS) in the Intent To Treat Population (ITT) With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears [ Time Frame: Baseline to month 24 ]The secondary effectiveness endpoint was defined as mean change from baseline to Month 24 for Constant-Murley (CS) Shoulder Outcome score (where the scale of 0-100:higher score is better) in the two groups, InSpace and Partial Repair.
- The Mean Change From Baseline to Month 24 for EQ-5D-5L for Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears [ Time Frame: Baseline through to month 24 ]The secondary effectiveness endpoint was defined as change in baseline to Month 24 for Quality of Life (EQ-5D-5L) (scale of 0-100: lower score better) in the two groups, InSpace and Partial Repair.
- Mean Change From Baseline to Month 24 for VAS in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears [ Time Frame: Baseline through to month 24 ]The secondary effectiveness endpoint was defined as the mean change from baseline at Month 24 for Visual Analogue Scale (VAS) (scale of 0-100:lower score is better) in the two groups, InSpace and Partial Repair.
- Mean Change From Baseline to Month 24 for ASES ROM in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears [ Time Frame: Baseline through to month 24 ]The secondary effectiveness endpoint was defined as mean change from baseline at Month 24 for American Shoulder and Elbow Surgeons (ASES) range of motion (ROM)-physician reported portion. (scale of 0-180 Degrees: higher score is better) in the two groups, InSpace and Partial Repair.
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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 |
Study Documents (Full-Text)
Documents provided by OrthoSpace Ltd.:
Documents provided by OrthoSpace Ltd.:
Study Protocol and Statistical Analysis Plan [PDF] March 26, 2018
Informed Consent Form [PDF] March 26, 2018
| Responsible Party: | OrthoSpace Ltd. |
| ClinicalTrials.gov Identifier: | NCT02493660 |
| Other Study ID Numbers: |
CLD-OR-010 |
| First Posted: | July 9, 2015 Key Record Dates |
| Results First Posted: | July 22, 2021 |
| Last Update Posted: | June 15, 2022 |
| Last Verified: | June 2022 |
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 |