Double Raw RepairKnotless2NCT07828366
The Clinical and Ultrasound Outcomes of Double-row "Knotless" Rotator Cuff Repairs Using the Montgolfier Technique
A study testing Rotator cuff repair, ultrasound and Questionnaires in people with Double Raw Repair and Rotator Cuff, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
Arthroscopic repairs of rotator cuff tears are now predominantly performed using double-row anchor and suture techniques. This approach is considered to have superior biomechanics compared to previous single-row repair techniques. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Double Raw Repair, Rotator Cuff
- What is being tested?
- Rotator cuff repair, ultrasound and Questionnaires
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteFrance
- Study dates
- 10 Oct 2026to 30 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patient aged over 18,
- Patient scheduled for rotator cuff repair using the Montgolfier double-row technique,
- Patient affiliated with or a beneficiary of a social security scheme,
- Patient who has been informed and has provided free, informed, and written consent.
Who cannot join
- Patient who has previously undergone shoulder surgery
- Patient with a shoulder condition resulting from a workplace accident or suffering from an occupational disease
- Patients lacking the intellectual or physical capacity to provide consent
- Protected patient: adult under guardianship, curatorship, or other legal protection; deprived of liberty by judicial or administrative decision; or under judicial protection
- Pregnant, breastfeeding, or recently delivered woman
- Patient hospitalized without consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpital privé Jean Mermoz
Lyon, 69008
Lionel Neyton, Dr, 0437530057 ext. 0033, neyton.lionel@orange.fr
About this study
Official title: Pilot Study on the Clinical and Ultrasound Outcomes of Double-row "Knotless" Rotator Cuff Repairs Using the Montgolfier Technique
Arthroscopic repairs of rotator cuff tears are now predominantly performed using double-row anchor and suture techniques. This approach is considered to have superior biomechanics compared to previous single-row repair techniques. Numerous double-row techniques with a knotted medial row have been described, but a consensus regarding their performance has yet to be established. One such technique is effective and easily reproducible: the "double-row Montgolfier" arthroscopic repair technique. This knotless approach features a uniformly distributed, load-sharing, and radially oriented suture configuration, much like the envelope cables of a Montgolfier hot air balloon, its namesake. Other advantages include the possibility of applying progressive manual tension to each suture and easy intraoperative adjustments based on the size, shape, and delamination of the tear, as well as the tension and quality of the tissues. Future studies are needed to validate the biomechanics and clinical outcomes of this technique. To date, only one publication describes this technique, from which its practice is gradually developing in France. No studies currently evaluate the performance of this approach. This pilot study will provide data to inform the design of other studies.
The main objective of this study is to evaluate the clinical results (functional and pain) of the "Montgolfier Double-Row Knotless" technique at 12 months of follow-up.
- Conditions
- Double Raw Repair, Rotator Cuff
- Being tested
- Rotator cuff repair, ultrasound, Questionnaires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotator cuff repairProcedure or surgery
Rotator cuff repair using the Montgolfier double-row technique.
ultrasoundProcedure or surgery
Ultrasound at 6 months and one year after surgery
QuestionnairesOther
Questionnaires :
- American Shoulder and Elbow Surgeons (ASES),
- Simple shoulder test (SST)
- The Single Assessment Numeric Evaluation (SANE)
- EVA pain score
| Study group | Role | What they receive |
|---|---|---|
| Patient scheduled for rotator cuff repair using the Montgolfier double-row technique. | Experimental | Not described Receives: Procedure: Rotator cuff repair; Procedure: ultrasound; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of the MCID (Minimal Clinically Important Difference) for the ASES (American Shoulder and Elbow Surgeons) score at 12 months.
For each patient, the change in the ASES score between day 0 and 12 months will be calculated. The patient will be considered successful if this change is greater than or equal to 27.1 (MCID of the ASES score).
Measured: between day 0 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start10 Oct 2026 (estimated)
- Primary completion10 Oct 2028 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Double Raw RepairStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828366
- Sponsor's protocol ID
- 2025-A00703-46
- Acronym
- Knotless2
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 18 Sep 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 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Clinical and Ultrasound Outcomes of Double-row "Knotless" Rotator Cuff Repairs Using the Montgolfier Technique
- ClinicalTrials.gov ID
- NCT07828366
- Acronym / sponsor ID
- Knotless2 / 2025-A00703-46
- Conditions
- Double Raw Repair, Rotator Cuff
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 10 Oct 2026 (estimated)
- Primary completion
- 10 Oct 2028 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 18 Sep 2026 (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.
Arthroscopic repairs of rotator cuff tears are now predominantly performed using double-row anchor and suture techniques. This approach is considered to have superior biomechanics compared to previous single-row repair techniques. Numerous double-row techniques with a knotted medial row have been described, but a consensus regarding their performance has yet to be established. One such technique is effective and easily reproducible: the "double-row Montgolfier" arthroscopic repair technique. This knotless approach features a uniformly distributed, load-sharing, and radially oriented suture configuration, much like the envelope cables of a Montgolfier hot air balloon, its namesake. Other advantages include the possibility of applying progressive manual tension to each suture and easy intraoperative adjustments based on the size, shape, and delamination of the tear, as well as the tension and quality of the tissues. Future studies are needed to validate the biomechanics and clinical outcomes of this technique. To date, only one publication describes this technique, from which its practice is gradually developing in France. No studies currently evaluate the performance of this approach. This pilot study will provide data to inform the design of other studies.
The main objective of this study is to evaluate the clinical results (functional and pain) of the "Montgolfier Double-Row Knotless" technique at 12 months of follow-up.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient scheduled for rotator cuff repair using the Montgolfier double-row technique. | Experimental | Procedure: Rotator cuff repair, Procedure: ultrasound, Other: Questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female patient aged over 18,
- Patient scheduled for rotator cuff repair using the Montgolfier double-row technique,
- Patient affiliated with or a beneficiary of a social security scheme,
- Patient who has been informed and has provided free, informed, and written consent.
Key exclusion criteria (6 listed)
- Patient who has previously undergone shoulder surgery
- Patient with a shoulder condition resulting from a workplace accident or suffering from an occupational disease
- Patients lacking the intellectual or physical capacity to provide consent
- Protected patient: adult under guardianship, curatorship, or other legal protection; deprived of liberty by judicial or administrative decision; or under judicial protection
- Pregnant, breastfeeding, or recently delivered woman
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 |
|---|---|---|
| Rotator cuff repairRotator cuff repair using the Montgolfier double-row technique. | Procedure or surgery | Patient scheduled for rotator cuff repair using the Montgolfier double-row technique. |
| ultrasoundUltrasound at 6 months and one year after surgery | Procedure or surgery | Patient scheduled for rotator cuff repair using the Montgolfier double-row technique. |
| QuestionnairesQuestionnaires : * American Shoulder and Elbow Surgeons (ASES), * Simple shoulder test (SST) * The Single Assessment Numeric Evaluation (SANE) * EVA pain score | Other | Patient scheduled for rotator cuff repair using the Montgolfier double-row technique. |
Primary outcome
Achievement of the MCID (Minimal Clinically Important Difference) for the ASES (American Shoulder and Elbow Surgeons) score at 12 months.
Time frame: between day 0 and 12 months
For each patient, the change in the ASES score between day 0 and 12 months will be calculated. The patient will be considered successful if this change is greater than or equal to 27.1 (MCID of the ASES score).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
Related trials for Double Raw Repair
Enrolling by invitation
Does Medial Raw Anchor Necessary During Tendon Repair Combined With Microfracture
Full Rotator Cuff Tear, Microfracture Procedure
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rotator cuff repair, ultrasound and Questionnaires in people with Double Raw Repair and Rotator Cuff, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 18 Sep 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-François Oudet, M. (0033683346567, jf.oudet@ecten.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achievement of the MCID (Minimal Clinically Important Difference) for the ASES (American Shoulder and Elbow Surgeons) score at 12 months. (time frame: between day 0 and 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 18 Sep 2026.