InSpace™ System Implantation in a Procedure Under Local A... | NCT02208453

Studies
InSpace™ System Implantation in a Procedure Under Local Anesthesia

NCT02208453

Sponsor

OrthoSpace Ltd.

Status

Completed

Last Update Posted

Aug 28, 2019Actual

Enrollment

45Actual

Phase

Not Applicable

Conditions

Rotator Cuff Tear

Interventions

InSpace Implantation

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
72746	Other Identifier	Santa Maria Della Miserecordia, Udine

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013Actual

Primary Completion Date

Jun 2018Actual

Completion Date

Apr 2019Actual

First Submitted Date

Jun 29, 2013

First Submission Date that Met QC Criteria

Aug 3, 2014

First Posted Date

Aug 5, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 27, 2019

Last Update Posted Date

Aug 28, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
InSpace implantation	Experimental	InSpace device implantation	Device: InSpace Implantation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
InSpace Implantation	Device	InSpace device Implantation	InSpace implantation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in total shoulder outcome scores (Constant and ASES)	Change in total shoulder outcome scores (Constant and ASES)at 6 month post implantattion	6 months post implanatation

Secondary Outcomes

Measure	Description	Time Frame
Change in Total Shoulder scores	Change in Total Shoulder scores and improvement compare to baseline at each time point (6W, 3m, 12m and 24m).	up to 24 months post implantation

Other Outcomes

Measure	Description	Time Frame
Safety Assessment	The Safety assessment will include all device related AEs/SAEs throughout the entire study period.	24 months post implantation

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 50 or older.
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).
Persistent pain and failure of non-operative treatment of the affected shoulder for at least 3 months.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Enrico Gervasi, MD	Orthopedic Department, Latisana Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital of Latisana		Latisana	Udine	33503	Italy

References Module

Citations

Not provided

ID	Term
D012421	Rupture
D014947	Wounds and Injuries
D000070599	Shoulder Injuries
D013708	Tendon Injuries