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InSpace™ System Implantation in a Procedure Under Local Anesthesia

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ClinicalTrials.gov Identifier: NCT02208453
Recruitment Status : Completed
First Posted : August 5, 2014
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
OrthoSpace Ltd.

Brief Summary:
The study objective is to assess the feasibility, efficacy and safety of the InSpace™ Device implantation in a surgical procedure under local anesthesia using arthroscopic and/or fluoroscopic visualization of the affected shoulder.

Condition or disease Intervention/treatment Phase
Rotator Cuff Tear Device: InSpace Implantation Not Applicable

Detailed Description:

A single arm, open-label, prospective, study to assess the feasibility, efficacy and safety of InSpace™ device implantation in a procedure under local anesthesia for a treatment of subjects with massive, irreparable rotator cuff tear.

Subjects with radiological confirmed massive RCT who are eligible per inclusion/exclusion criteria, will be enrolled for the study treatment.

Subjects will undergo surgical intervention under local anesthesia , fluoroscopic and/ or arthroscopic visualization of InSpace™ implantation.

Subjects will then be followed for safety and efficacy for a 24 months following the implantation.

The study objective is to assess the feasibility, efficacy and safety of the InSpace™ Device implantation in a surgical procedure under local anesthesia using arthroscopic and/or fluoroscopic visualization of the affected shoulder.

The efficacy will be assess by using Constant and ASES outcome score The Constant and the ASES will be completed by the investigator at each study visit .The patient will complete the patient self-evaluation part of the ASES at each study visit.

The Safety assessment will be conducted by collecting all device related AEs/SAEs throughout the entire study period.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
Official Title: A Single Arm, Open-label, Prospective, Study to Assess the Feasibility, Efficacy and Safety of InSpace™ Device Implantation in a Procedure Under Local Anesthesia for a Treatment of Subjects With Massive, Irreparable Rotator Cuff Tear
Actual Study Start Date : January 2013
Actual Primary Completion Date : June 2018
Actual Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
Experimental: InSpace implantation
InSpace device implantation
Device: InSpace Implantation
InSpace device Implantation




Primary Outcome Measures :
  1. Change in total shoulder outcome scores (Constant and ASES) [ Time Frame: 6 months post implanatation ]
    Change in total shoulder outcome scores (Constant and ASES)at 6 month post implantattion


Secondary Outcome Measures :
  1. Change in Total Shoulder scores [ Time Frame: up to 24 months post implantation ]
    Change in Total Shoulder scores and improvement compare to baseline at each time point (6W, 3m, 12m and 24m).


Other Outcome Measures:
  1. Safety Assessment [ Time Frame: 24 months post implantation ]
    The Safety assessment will include all device related AEs/SAEs throughout the entire study period.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 50 or older.
  2. Positive diagnostic MRI of the affected shoulder indicating full thickness massive irreparable RCT of at least 5cm in diameter (according to Cofield classification) including fatty infiltration grade III or IV (according to classification of Goutallier).
  3. Persistent pain and failure of non-operative treatment of the affected shoulder for at least 3 months.

Exclusion Criteria:

  1. Known allergy to the balloon material
  2. Evidence of significant osteoarthritis or cartilage damage in the shoulder
  3. Evidence of gleno-humeral instability
  4. Evidence of major joint trauma, infection, or necrosis in the shoulder
  5. Major medical condition or known drug or alcohol abuses that could affect quality of life and influence the results of the study.
  6. Concurrent participation in any other invasive clinical study one month prior to enrollment to the study and during the entire study period.
  7. Subjects with worker's compensation claims or other litigation claims related to the shoulder being treated in the study.

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): NCT02208453


Locations
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Italy
Hospital of Latisana
Latisana, Udine, Italy, 33503
Sponsors and Collaborators
OrthoSpace Ltd.
Investigators
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Principal Investigator: Enrico Gervasi, MD Orthopedic Department, Latisana Hospital
Additional Information:
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Responsible Party: OrthoSpace Ltd.
ClinicalTrials.gov Identifier: NCT02208453    
Other Study ID Numbers: IS-CL-05
72746 ( Other Identifier: Santa Maria Della Miserecordia, Udine )
First Posted: August 5, 2014    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Keywords provided by OrthoSpace Ltd.:
Massive Rotator Cuff Tear
Local anesthesia
Sub-acromial spacer
Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries