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NCT07828366
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The Clinical and Ultrasound Outcomes of Double-row "Knotless" Rotator Cuff Repairs Using the Montgolfier Technique

Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

View on ClinicalTrials.gov

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.

Official title: Pilot Study on the Clinical and Ultrasound Outcomes of Double-row "Knotless" Rotator Cuff Repairs Using the Montgolfier Technique

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

78

Start Date

2026-10-10

Completion Date

2028-10-30

Last Updated

2026-09-18

Healthy Volunteers

No

Interventions

PROCEDURE

Rotator cuff repair

Rotator cuff repair using the Montgolfier double-row technique.

PROCEDURE

ultrasound

Ultrasound at 6 months and one year after surgery

OTHER

Questionnaires

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

Locations (1)

Hôpital privé Jean Mermoz

Lyon, France