CompletedNCT02208453Updated Aug 28, 2019

InSpace™ System Implantation in a Procedure Under Local Anesthesia

An interventional study of InSpace Implantation in Rotator Cuff Tear, sponsored by OrthoSpace Ltd.. Completed at 1 site in Italy. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2019-08-28.

Sponsored by OrthoSpace Ltd. (part of Stryker) · Not applicable, Interventional, and Treatment

From the registry’s dates

Registered 5 months after the study started (first participant enrolled Jan 2013, registered Jun 2013).

Phase: Not applicable
Study type: Interventional
Enrollment: 45
Allocation: Not applicable
Ages: 50 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

Rotator Cuff Tear

Browse trials for

Rotator Cuff Injuries 745

Keywords

Massive Rotator Cuff Tear
Local anesthesia
Sub-acromial spacer

In context

Rotator Cuff Injuries

745 studies on the registry are indexed under Rotator Cuff Injuries; 163 are open to participants now.

This study's enrollment of 45 is below the median of 60 across 547 interventional studies indexed under Rotator Cuff Injuries.

Browse Rotator Cuff Injuries studies →

Lead sponsor

OrthoSpace Ltd. is the lead sponsor of 7 studies on the registry; none are open to participants now.

First submitted before OrthoSpace Ltd. became part of Stryker.

Browse OrthoSpace Ltd. studies →All Stryker studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 50 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 45 participants (actual)

Study arms

Experimental
InSpace implantation
InSpace device implantation
Device: InSpace Implantation

Interventions

DeviceInSpace Implantation
InSpace device Implantation

What researchers measure

Primary outcomes

Change in total shoulder outcome scores (Constant and ASES)
Change in total shoulder outcome scores (Constant and ASES)at 6 month post implantattion
Time frame: 6 months post implanatation

Secondary outcomes

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

Other outcomes

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

Study locations

1 site

Hospital of Latisana
Latisana, Udine 33503, Italy

References and documents

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2013 to primary completion in Jun 2018, 65 months.

Of 306 interventional studies with no phase under Rotator Cuff Injuries, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 39. This study's 65 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered: Jun 29, 2013
First posted: Aug 5, 2014
StartActual: Jan 2013
Primary completionActual: Jun 2018
CompletionActual: Apr 2019
Last update: Aug 28, 2019

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Aug 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02208453
Lead sponsor: OrthoSpace Ltd.
Responsible party: Sponsor
First posted: Aug 5, 2014
Start date: Jan 2013
Primary completion: Jun 2018
Completion: Apr 2019
Last update: Aug 28, 2019

Study contacts

Enrico Gervasi, MD

principal investigator · Orthopedic Department, Latisana Hospital

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Rotator Cuff Injuries →

Other studies from this sponsor

OrthoSpace Ltd. →

Start the discussion