Clinical Trial on the Effect of the Flexible Suturing System With Anchors (FSSA) in Full-thicknes… (NCT06868108) | Clinical Trial Compass
By InvitationNot Applicable
Clinical Trial on the Effect of the Flexible Suturing System With Anchors (FSSA) in Full-thickness Rotator Cuff Tendon Tears
United States100 participantsStarted 2025-02-20
Plain-language summary
The purpose of this research study is to evaluate tendon healing when using the Flexible Suturing System with Anchors (FSSA) to surgically repair full-thickness rotator cuff tendon tears.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Underwent surgery to repair a torn rotator cuff tear with the Flexible Suturing System with Anchors (FSSA) and is able to obtain a follow-up MRI within 12 months +4 months / -1 month from the surgery date.
✓. Tear size of the supraspinatus (SSP) with or without involvement of the infraspinatus (ISP), confirmed intra-operatively or with the pre-procedural MRI, is greater than or equal to 1 cm.
✓. Between 18 and 70 years old at the time of surgery.
✓. Able to understand the content of the subject information / Informed Consent Form (ICF) and is willing and able to participate in the prospective data collection protocol and comply with the required data collection.
Exclusion criteria
✕. Had a prior rotator cuff surgery on the index shoulder.
✕. Has a subscapularis tear with a Lafosse score of 3 or greater, or a teres minor tear requiring repair.
✕. Identified as being repaired in a hybrid approach, where a non-FSSA anchor is used in the case for SSP and/or ISP rotator cuff repair.
✕. SSP and / or ISP tendon ruptures that are considered irreparable or only partially repairable at the time of the intervention.
✕. At any time during the previous 18 months was involved in a workers compensation case or litigation related to bodily injury, whether related or unrelated to the index shoulder.
. Subjects with condition(s) that contraindicate or complicate outcomes of ARCR such as:
✕. Has other concurrent medical or other conditions (chronic or acute in nature) that in the opinion of the participating investigator may prevent participation or otherwise render subject ineligible for the study.