The Clinical and Ultrasound Outcomes of Double-row "Knotless" Rotator Cuff Repairs Using the Montgolfier Technique

NCT07828366 | Not Yet Recruiting

• 1 other identifier: 2025-A00703-46
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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. 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

Rotator Cuff; Double Raw Repair

Outcome Measures

Primary Outcomes (1)

• 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).

  between day 0 and 12 months

Study Arms (1)

Patient scheduled for rotator cuff repair using the Montgolfier double-row technique.

EXPERIMENTAL

Procedure: Rotator cuff repair; Procedure: ultrasound; Other: Questionnaires

Interventions

Rotator cuff repair PROCEDURE

Rotator cuff repair using the Montgolfier double-row technique.

Patient scheduled for rotator cuff repair using the Montgolfier double-row technique.

ultrasound PROCEDURE

Ultrasound at 6 months and one year after surgery

Patient scheduled for rotator cuff repair using the Montgolfier double-row technique.

Questionnaires OTHER

Questionnaires : * American Shoulder and Elbow Surgeons (ASES), * Simple shoulder test (SST) * The Single Assessment Numeric Evaluation (SANE) * EVA pain score

Patient scheduled for rotator cuff repair using the Montgolfier double-row technique.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Hôpital privé Jean Mermoz

Lyon, 69008, France

Location

MeSH Terms

Interventions

High-Energy Shock Waves; Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Jean-François Oudet, M.

CONTACT

0033683346567; jf.oudet@ecten.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 18, 2026
• Study Start (Estimated): October 10, 2026
• Primary Completion (Estimated): October 10, 2028
• Study Completion (Estimated): October 30, 2028
• Last Updated: September 18, 2026

Record last verified: 2026-09

Locations

FR (1)