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

N/ANot Yet RecruitingNCT07828366

GCS Ramsay Santé pour l'Enseignement et la Recherche78 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Double Raw Repair

Interventions

Rotator cuff repairPROCEDURE

Rotator cuff repair using the Montgolfier double-row technique.

ultrasoundPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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).

Time frame: between day 0 and 12 months