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Could a tiny spacer prevent rotator cuff Re-Tears?

NCT ID NCT04704700

Disease control Sponsor: Clinique Bizet Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether adding a small balloon-like spacer (InSpace) during rotator cuff repair surgery helps prevent the tendon from tearing again. Thirty adults with a first-time rotator cuff tear were split into two groups: one got standard repair, the other got repair plus the spacer. Researchers checked re-tear rates, shoulder mobility, pain, and quality of life one year after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
InSpace spacer (a balloon-like device implanted during surgery)
What this could lead to
If successful, this could offer a way to lower the chance of rotator cuff re-tears after surgery, improving recovery and shoulder function.
What could go wrong
This is a small, early-stage study with only 30 participants, so results may not apply to everyone. The spacer is a device, not a drug, and its long-term benefits are still uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

30 people

The number who actually took part.

Started

Sep 2021

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * First intention of the rotator cuff * Repairable supraspinatus and infraspinatus type 2 rupture (according to the PATTE classification, tendon retraction at the top of the humeral head) * No surgical history * Patient who has given his participation agreement to participate in the observational study after information by the surgeon, * Patient living in France and having the capacity to answer alone to the survey. * Subject affiliated to a social security scheme * Lack of participation in another clinical study Exclusion Criteria: * Major subject protected by law, under curatorship or tutorship * Known allergy to Inspace medical device materials (PLA and -θ-caprolactone copolymer) * Osteoporosis * Damaged cartilage * Isolated rupture of the suprascapularis * Glenohumeral instability * Pseudo-paralytic shoulder- Infection * Necrosis * Major joint trauma * Pregnant or breastfeeding women

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Conditions

The condition(s) this trial relates to.

rotator cuff syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Repair of A cuff tear

Contacts and locations

Locations

  • Clinique Bizet

    Paris, 75016, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.