NCT02208440

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 .

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 5, 2014

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

June 5, 2020

Status Verified

August 1, 2019

Enrollment Period

4 years

First QC Date

August 3, 2014

Last Update Submit

June 3, 2020

Conditions

Full-thickness Rotator Cuff Tear

Keywords

Full-thickness/Massive Rotator Cuff Tear, Sub-acromial spacer

Outcome Measures

Primary Outcomes (1)

  • The change in the Shoulder Score

    baseline and 6 months

Study Arms (2)

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

Best Repair of torn Rotator CuffPROCEDURE
Best Repair of torn Rotator Cuff
InSpace™ systemDEVICE
InSpace™ system

Eligibility Criteria

Age40 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 40 or older.
  • Positive diagnostic imaging of the affected shoulder indicating full thickness Massive RCT involving more than one tendon.
  • Persistent pain and functional disability of the affected shoulder for at least 3 months.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wigan and Leigh NHS Foundation Trust: Upper Limb & Trauma Surgery

Wigan, Hall Lane, Appley Bridge, WN69EP, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The patient is blinded to the treatment type
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2014

First Posted

August 5, 2014

Study Start

July 1, 2014

Primary Completion

July 1, 2018

Study Completion

January 1, 2019

Last Updated

June 5, 2020

Record last verified: 2019-08

Locations

GB(1)