InSpace™ System in Comparison to Best Repair of Massive R... | NCT02211183

Studies
InSpace™ System in Comparison to Best Repair of Massive Rotator Cuff Tear

NCT02211183

Sponsor

OrthoSpace Ltd.

Status

Terminated

Last Update Posted

Apr 6, 2018Actual

Enrollment

4Actual

Phase

Not Applicable

Conditions

Rotator Cuff Tear

Interventions

Best Repair of torn Rotator Cuff
InSpace™ system

Countries

Spain

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

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Very Low recruitment rate

Expanded Access Info

Start Date

Aug 2014

Primary Completion Date

Jan 2016Actual

Completion Date

Feb 2016Actual

First Submitted Date

Aug 6, 2014

First Submission Date that Met QC Criteria

Aug 6, 2014

First Posted Date

Aug 7, 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

Apr 4, 2018

Last Update Posted Date

Apr 6, 2018Actual

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

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 .

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).

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

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Best Repair of torn Rotator Cuff	Sham Comparator	Subjects will undergo surgical intervention (usually arthroscopy) to perform debridement, acromioplasty if deemed necessary, long head of biceps tenotomy, and at least partial repair.	Procedure: Best Repair of torn Rotator Cuff
InSpace™ system	Active Comparator	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.	Device: InSpace™ system

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Best Repair of torn Rotator Cuff	Procedure		Best Repair of torn Rotator Cuff
InSpace™ system

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The change in Shoulder Score from baseline		baseline and 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Emilio Calvo, MD	Head of Shoulder and Elbow Reconstructive Surgery Unit, Department of Orthopedic Surgery and Traumatology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fundacion Jimenez Diaz		Madrid		28040	Spain

Condition Browse Module

MeSH Terms

ID	Term
D000070636	Rotator Cuff Injuries

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided