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NCT Number: NCT07828366

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital privé Jean Mermoz

Lyon, 69008, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rotator Cuff Repair

Procedure

Rotator cuff repair using the Montgolfier double-row technique.

Ultrasound

Procedure

Ultrasound at 6 months and one year after surgery

questionnaires

Other

Questionnaires :

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

Primary outcomes

  1. 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).

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Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Official study title

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

Acronym: Knotless2

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 18, 2026
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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