The Clinical and Ultrasound Outcomes of Double-row "Knotless" Rotator Cuff Repairs Using the Montgolfier Technique (Knotless2)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jean-François Oudet, M.
- Phone Number: 0033683346567
- Email: jf.oudet@ecten.eu
Study Locations
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Lyon, France, 69008
- Hôpital privé Jean Mermoz
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Contact:
- Lionel Neyton, Dr
- Phone Number: 0033 0437530057
- Email: neyton.lionel@orange.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Patient scheduled for rotator cuff repair using the Montgolfier double-row technique.
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Rotator cuff repair using the Montgolfier double-row technique.
Ultrasound at 6 months and one year after surgery
Questionnaires :
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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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).
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between day 0 and 12 months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Physical Phenomena
- Radiation
- Radiation, Nonionizing
- Ultrasonic Waves
- Sound
- Surveys and Questionnaires
- High-Energy Shock Waves
Other Study ID Numbers
- 2025-A00703-46
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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