Rotator Cuff TearsNCT06868108
Clinical Trial on the Effect of the Flexible Suturing System With Anchors (FSSA) in Full-thickness Rotator Cuff Tendon Tears
An observational study of Rotator Cuff Tears, run by Integrity Orthopaedics, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Flexible Suturing System with Anchors (FSSA)
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Feb 2025to 14 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: An individual that underwent surgery to repair a torn rotator cuff tear with the Flexible Suturing System with Anchors (FSSA).
Who may be able to join
- Subjects MUST meet ALL the following criteria to be included in the study:
- 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.
Who cannot join
- Subjects will be excluded from the study if they meet ANY of the following 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.
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- Has a history of chronic opioid use.
- Subjects with condition(s) that contraindicate or complicate outcomes of ARCR such as:
- Current or prior infection of the ipsilateral shoulder
- Known inflammatory arthropathy or history of inflammatory arthropathy
- Chronic joint disease
- Concomitant labral fixation
- Concomitant os acromial fixation
- Glenohumeral joint instability (multiple dislocations/subluxations)
- Subacromial or intra-articular injection within 3 months prior to surgery
- Oral or injected steroid use in the following timeframe: 4 weeks prior to surgery through current date
- Hamada 3 or greater rotator cuff arthropathy on X-ray
- Goutallier atrophy > Grade 3
- Proximal humeral fracture or scapular fracture
- Avascular necrosis of humeral head or glenoid
- Immunodeficiency disorders
- Chronic inflammatory disorders
- Osteoarthritis >2 (Samilson-Prieto)
- 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.
- Subjects who are unable to tolerate magnetic resonance imaging (MRI), due to psychiatric or medical contraindications.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Texas Orthopedic Specialist
Bedford, Texas, 76021
OrthoCarolina Research Institute
Charlotte, North Carolina, 28207
Houston Methodist The Woodlands
The Woodlands, Texas, 77385
About this study
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.
- Conditions
- Rotator Cuff Tears
- Being tested
- Flexible Suturing System with Anchors (FSSA)
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible Suturing System with Anchors (FSSA)Device
Surgically repaired full-thickness rotator cuff tendon tears with the Flexible Suturing System with Anchors (FSSA).
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing Rate
The cumulative healing rate of the repaired rotator cuff tendon, confirmed through MRI, studied one year after the intervention and using the Sugaya classification (Sugaya H (2005)), where healing is defined as Sugaya Type I, II, or III.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start20 Feb 2025
- Primary completion11 May 2026
- Study completion14 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integrity Orthopaedics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06868108
- Sponsor's protocol ID
- DN-00808
- Status last verified
- Nov 2026
- First submitted
- 5 Mar 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial on the Effect of the Flexible Suturing System With Anchors (FSSA) in Full-thickness Rotator Cuff Tendon Tears
- ClinicalTrials.gov ID
- NCT06868108
- Acronym / sponsor ID
- DN-00808
- Conditions
- Rotator Cuff Tears
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Integrity Orthopaedics, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 11 May 2026 (actual)
- Study completion
- 14 Jul 2026 (actual)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- An individual that underwent surgery to repair a torn rotator cuff tear with the Flexible Suturing System with Anchors (FSSA).
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flexible Suturing System with Anchors (FSSA)Surgically repaired full-thickness rotator cuff tendon tears with the Flexible Suturing System with Anchors (FSSA). | Device | – |
Primary outcome
Healing Rate
Time frame: One year
The cumulative healing rate of the repaired rotator cuff tendon, confirmed through MRI, studied one year after the intervention and using the Sugaya classification (Sugaya H (2005)), where healing is defined as Sugaya Type I, II, or III.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Tears, run by Integrity Orthopaedics, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing Rate (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.