- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02211183
InSpace™ System in Comparison to Best Repair of Massive Rotator Cuff Tear
April 4, 2018 updated by: OrthoSpace Ltd.
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.
This is a post-marketing study to further assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical repair of full thickness Massive Rotator Cuff Tear .
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
The effectiveness will be assessed by comparing the scores of the ASES, Constant and Quick DASH outcome questionnaires with respect to pain reduction, improvement of activity of daily living (ADL) and improvement of range of motion (ROM).
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Madrid, Spain, 28040
- Fundación Jiménez Díaz
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 95 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Main Inclusion Criteria:
- Age 40 or older.
- Positive diagnostic imaging of the affected shoulder indicating full thickness Massive RCT (according to Cofield classification) or long involving more than one tendon.
- Persistent pain and functional disability of the affected shoulder for at least 3 months.
Main Exclusion Criteria :
- Known allergy to the balloon material (copolymer of PLA and -θ-caprolactone).
- Evidence of significant osteoarthritis or cartilage damage in the shoulder
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Sham Comparator: Best Repair of torn Rotator Cuff
Subjects will undergo surgical intervention (usually arthroscopy) to perform debridement, acromioplasty if deemed necessary, long head of biceps tenotomy, and at least partial repair.
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Active Comparator: InSpace™ system
Subjects will undergo surgical intervention (usually arthroscopy or mini invasive) of debridement, acromioplasty if deemed necessary with or without long head of biceps tenotomy, and placement of the InSpace™ system.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The change in Shoulder Score from baseline
Time Frame: baseline and 6 months
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baseline and 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Emilio Calvo, MD, Head of Shoulder and Elbow Reconstructive Surgery Unit, Department of Orthopedic Surgery and Traumatology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2014
Primary Completion (Actual)
January 1, 2016
Study Completion (Actual)
February 1, 2016
Study Registration Dates
First Submitted
August 6, 2014
First Submitted That Met QC Criteria
August 6, 2014
First Posted (Estimate)
August 7, 2014
Study Record Updates
Last Update Posted (Actual)
April 6, 2018
Last Update Submitted That Met QC Criteria
April 4, 2018
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IS-CL-02-SP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rotator Cuff Tear
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Bezmialem Vakif UniversityNot yet recruitingRotator Cuff Tears | Partial Tear of Rotator CuffTurkey
-
Keele UniversityUniversity Hospitals, Leicester; Liverpool University Hospitals NHS Foundation... and other collaboratorsWithdrawnTraumatic Rotator Cuff TearUnited Kingdom
-
Rush University Medical CenterSmith & Nephew, Inc.CompletedRotator Cuff Tear Repair Anchors
-
University of MichiganCompletedFull Thickness Rotator Cuff Tear
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Johannes Kepler University of LinzCompletedFull Thickness Rotator Cuff TearAustria
-
Lawson Health Research InstituteCompleted
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Borja Alcobía-Díaz MD, PhDNot yet recruiting
-
Fondren Orthopedic Group L.L.P.Not yet recruitingRotator Cuff Tear Arthropathy | Massive Irreparable Rotator Cuff TearUnited States
-
Rush University Medical CenterActive, not recruitingFull Thickness Rotator Cuff TearUnited States
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Orthopedic Institute, Sioux Falls, SDCompletedFull Thickness Rotator Cuff TearUnited States
Clinical Trials on Best Repair of torn Rotator Cuff
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OrthoSpace Ltd.TerminatedFull-thickness Rotator Cuff TearUnited Kingdom
-
OrthoSpace Ltd.TerminatedFull- Thickness Massive RCT (MRCT) of at Least 5 cm in Diameter Including Fatty Infiltration Grade III or IVItaly
-
OrthoSpace Ltd.Completed
-
Smith & Nephew, Inc.TerminatedRotator Cuff InjuriesUnited States, Hong Kong, United Kingdom, France, Singapore, Switzerland, Australia, Canada
-
CONMED CorporationRecruitingRotator Cuff TearsUnited States
-
Saint Lucas Hospital, PolandRecruitingRotator Cuff Injuries | Shoulder Pain Chronic | Massive Rotator Cuff TearsPoland
-
Seoul National University HospitalCompleted
-
Göker Utku değerSuspendedRotator Cuff Tears | Micro FractureTurkey
-
Chang Gung Memorial HospitalRecruiting
-
RenJi HospitalNot yet recruiting