Can a tiny spacer restore shoulder function in massive tears?
NCT ID NCT07745647
First seen Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time
Summary
This early-stage trial is testing a new non-degradable shoulder spacer in people over 50 with massive rotator cuff tears. The spacer is designed to be placed in the shoulder to help improve pain and function. The study will look at how safe the device is and whether it helps with symptoms.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Voll Non-Degradable Shoulder Spacer
- What this could lead to
- If successful, this spacer could offer a new treatment option for massive rotator cuff tears, potentially reducing pain and improving shoulder function without the need for more invasive surgery.
- What could go wrong
- This is a very early, first-in-human study with only 10 participants, so safety and effectiveness are not yet established. The device may not provide the expected benefits or could cause complications.
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
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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
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Full thickness MRCT. * Male or female patients ≥ fifty (50) years of age, in general good health, independent, and can comply with all post-operative evaluations and visits. Exclusion Criteria: * Documented evidence of a history of drug/alcohol abuse within 1 year of enrollment. * Concurrent participation in any other investigational clinical study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Assuta Ashdod Hospital
Ashdod, Israel
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Mind over muscle: mental training may speed shoulder healing
- New gel may stop shoulder implant infections in men
- New surgical trick for massive rotator cuff tears shows promise
- App-Based rehab could replace office visits after shoulder surgery
- Shoulder surgery showdown: which fix works best for massive rotator cuff tears?
- Dissolvable shoulder implant offers new hope for torn rotator cuffs