Repair of a Cuff TearESPACENCT04704700
Evaluate the Rotator Cuff Repair With "InSpace" VS Without "InSpace"
A study testing repair of a cuff tear in people with Repair of a Cuff Tear, run by Clinique Bizet at 1 site in France.
Trial summary
Evaluate the re-rupture rate 12 months following the intervention in a group with and a group without a spacer Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Repair of a Cuff Tear
- What is being tested?
- repair of a cuff tear
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2021to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Pseudo-paralytic shoulder- Infection
- Necrosis
- Major joint trauma
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
Evaluate the re-rupture rate 12 months following the intervention in a group with and a group without a spacer
- Conditions
- Repair of a Cuff Tear
- Being tested
- repair of a cuff tear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repair of a cuff tearDevice
Group (Treatment): Arthroscopic Implantation of the System InSpace on a repaired rotator cuff tendon
repair of a cuff tearDevice
Group (Control): standard Arthroscopic repair of the cuff rotator
| Study group | Role | What they receive |
|---|---|---|
| patient with inspace device | Active comparator | Not described Receives: Device: repair of a cuff tear |
| patient without inspace device | Placebo comparator | Not described Receives: Device: repair of a cuff tear |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the re-rupture rate
with radiological imaging
Measured: 12 months
Secondary outcomes (4)
Evaluate mobility
the Constant score
Measured: up to 12 months
Assess shoulder pain
VISUAL ANALOGIC SCALE
Measured: up to 12 months
the quality of life assessed
Simple Shoulder Test, Subjective Shoulder Value and American Shoulder and Elbow Surgeons Shoulder Score
Measured: up to 12 months
resumption of work
Physicians Global Assessment for resumption of work
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start1 Sep 2021
- Primary completion30 Jun 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Repair of a Cuff TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Bizet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- philippe VALENTI, DOCTOR, Principal investigator, Clinique Bizet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04704700
- Sponsor's protocol ID
- 2020-A02443-36
- Acronym
- ESPACE
- Status last verified
- Dec 2025
- First submitted
- 8 Jan 2021
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Rotator Cuff Repair With "InSpace" VS Without "InSpace"
- ClinicalTrials.gov ID
- NCT04704700
- Acronym / sponsor ID
- ESPACE / 2020-A02443-36
- Conditions
- Repair of a Cuff Tear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Clinique BizetUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 12 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the re-rupture rate 12 months following the intervention in a group with and a group without a spacer
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient with inspace device | Active comparator | Device: repair of a cuff tear |
| patient without inspace device | Placebo comparator | Device: repair of a cuff tear |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| repair of a cuff tearGroup (Treatment): Arthroscopic Implantation of the System InSpace on a repaired rotator cuff tendon | Device | patient with inspace device |
| repair of a cuff tearGroup (Control): standard Arthroscopic repair of the cuff rotator | Device | patient without inspace device |
Primary outcome
Evaluate the re-rupture rate
Time frame: 12 months
with radiological imaging
4 secondary outcomes
Evaluate mobility
Time frame: up to 12 months
Assess shoulder pain
Time frame: up to 12 months
the quality of life assessed
Time frame: up to 12 months
resumption of work
Time frame: up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
philippe VALENTI, DOCTOR principal investigator
Clinique Bizet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repair of a cuff tear in people with Repair of a Cuff Tear, run by Clinique Bizet at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the re-rupture rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.