Cuff Injury, RotatorNCT06059625
RECURRENCE OF ROTATOR CUFF LESION AFTER SURGICAL REPAIR WITH SINGLE-ROW vs DOUBLE-ROW SUTURE BRIDGE TECNIQUE: A COMPARATIVE STUDY
A study testing rotatori cuff repair in people with Cuff Injury, Rotator, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
The rotator cuff is a muscle-tendon complex consisting of the tendons of the supraspinatus, subspinatus, subscapularis, and small round muscles capable of allowing movement of the shoulder joint in the various planes of space and stabilizing the glenohumeral joint. Rotator cuff tendon injuries are very common. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Cuff Injury, Rotator
- What is being tested?
- rotatori cuff repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 14 Apr 2021to 31 May 2024
- Phase
- Interventional
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥45 years with a diagnosis of full-thickness rotator cuff injury <2cm
- Arthroscopic rotator cuff repair surgery with single row or double row suture bridge
- Follow-up > 24 months
- Completeness of clinical-radiographic documentation
- Patients at first rotator cuff repair surgery on affected side
Who cannot join
- Patients with associated injuries to the affected upper limb
- Patients with neuromuscular disorders, or established psychomotor disorders
- Patients with associated injuries of the subscapularis muscle tendon
- Patients with a history of previous surgery of the affected shoulder
- Patients with massive rotator cuff injury > 2cm
- Patients with severe pathologies of other organs or apparatuses that limit competitive or recreational sports activities
- Pregnant women
- Patients who cannot undergo high-field MRI (pcs with cochlear implants, cardiac, vascular or osteoarticular magnetic, pcs with previous gunshot wounds)
Trial locations and contacts
1 site in 1 country.
About this study
The rotator cuff is a muscle-tendon complex consisting of the tendons of the supraspinatus, subspinatus, subscapularis, and small round muscles capable of allowing movement of the shoulder joint in the various planes of space and stabilizing the glenohumeral joint.
Rotator cuff tendon injuries are very common. In most cases, these injuries are mostly degenerative based, as they are related to the aging process of the individual. However, it is increasingly common to diagnose such injuries in young individuals as well.
Read more
The reported incidence of rotator cuff injuries ranges from 5% to 40%, and of course the prevalence increases with age until it reaches 51% in patients older than 80 years.
The diagnosis of rotator cuff injury is made based on clinical examination and instrumental investigations such as Nuclear Magnetic Resonance Imaging (MRI).
Rotator cuff repair involves the use of anchors with included suture threads that allow the tendons to be returned to the level of the anatomical insertion, called the footprint.
Suture technique varies depending on the extent of injury and tendon and bone quality.
Single-row (single row) or double-row suture bridge (double-row suture bridge) anchoring techniques are currently a hotly debated topic in the literature.
- Conditions
- Cuff Injury, Rotator
- Being tested
- rotatori cuff repair
- 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.
rotatori cuff repairProcedure or surgery
rotatori cuff repair
| Study group | Role | What they receive |
|---|---|---|
| DOUBLE-ROW | Experimental | rotatori cuff repair with double-row suture bridge technique Receives: Procedure: rotatori cuff repair |
| SINGLE-ROW | Active comparator | rotatori cuff repair with single-row technique Receives: Procedure: rotatori cuff repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
radiological outcome (Sugaya score)
The Sugaya classification is used to evaluate rotator cuff repair, assessing post-operative rotator cuff repair on oblique coronal, oblique sagittal and transverse MRI planes.
Scores range from 0 to 5 with a score of 0 indicating better tendon quality and no lesion and 5 indicating worse tendon quality with complete lesion.
Measured: 24 months
clinical outcome (American Shoulder and Elbow Surgeons shoulder score)
ASES score is designed to assess the condition of the shoulder, regardless of disease pathology, requiring both a physician assessment and a patient-completed portion.
Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.
Measured: 24 months
clinical outcome (University of California and Los Angeles shoulder score)
UCLA shoulder score is a jointly completed score, with both physician and patient completed portions.
Scores range from 0 to 35 with a score of 0 indicating worse shoulder function and 35 indicating better shoulder function.
Measured: 24 months
clinical outcome (Costant-Murley score)
The Costant-Murley score is designed to assess the functional state of a normal, a diseased, or a treated shoulder. It contains both physician-completed and patient-reported portions.
Scores range from 0 points (most disability) to 100 points (least disability).
Measured: 24 months
clinical outcome (Range Of Motion)
ROM expresses in degrees the degree of range of motion that a joint can perform along its full range of motion whether active or passive through an external aid.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start14 Apr 2021
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cuff Injury, RotatorStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059625
- Sponsor's protocol ID
- CUFFIA3T
- Status last verified
- Jun 2024
- First submitted
- 22 Sep 2023
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khoriati AA, Antonios T, Gulihar A, Singh B. Single Vs Double row repair in rotator cuff tears - A review and analysis of current evidence. J Clin Orthop Trauma. 2019 Mar-Apr;10(2):236-240. doi: 10.1016/j.jcot.2019.01.027. Epub 2019 Jan 30. No abstract available.
PubMed 30828184Padua R, Padua L, Ceccarelli E, Bondi R, Alviti F, Castagna A. Italian version of ASES questionnaire for shoulder assessment: cross-cultural adaptation and validation. Musculoskelet Surg. 2010 May;94 Suppl 1:S85-90. doi: 10.1007/s12306-010-0064-9.
PubMed 20383686Sugaya H, Maeda K, Matsuki K, Moriishi J. Functional and structural outcome after arthroscopic full-thickness rotator cuff repair: single-row versus dual-row fixation. Arthroscopy. 2005 Nov;21(11):1307-16. doi: 10.1016/j.arthro.2005.08.011.
PubMed 16325080
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RECURRENCE OF ROTATOR CUFF LESION AFTER SURGICAL REPAIR WITH SINGLE-ROW vs DOUBLE-ROW SUTURE BRIDGE TECNIQUE: A COMPARATIVE STUDY
- ClinicalTrials.gov ID
- NCT06059625
- Acronym / sponsor ID
- CUFFIA3T
- Conditions
- Cuff Injury, Rotator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 28 Sep 2023 (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 rotator cuff is a muscle-tendon complex consisting of the tendons of the supraspinatus, subspinatus, subscapularis, and small round muscles capable of allowing movement of the shoulder joint in the various planes of space and stabilizing the glenohumeral joint.
Rotator cuff tendon injuries are very common. In most cases, these injuries are mostly degenerative based, as they are related to the aging process of the individual. However, it is increasingly common to diagnose such injuries in young individuals as well.
The reported incidence of rotator cuff injuries ranges from 5% to 40%, and of course the prevalence increases with age until it reaches 51% in patients older than 80 years.
The diagnosis of rotator cuff injury is made based on clinical examination and instrumental investigations such as Nuclear Magnetic Resonance Imaging (MRI).
Rotator cuff repair involves the use of anchors with included suture threads that allow the tendons to be returned to the level of the anatomical insertion, called the footprint.
Suture technique varies depending on the extent of injury and tendon and bone quality.
Single-row (single row) or double-row suture bridge (double-row suture bridge) anchoring techniques are currently a hotly debated topic in the literature.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DOUBLE-ROW | Experimental | Procedure: rotatori cuff repairrotatori cuff repair with double-row suture bridge technique |
| SINGLE-ROW | Active comparator | Procedure: rotatori cuff repairrotatori cuff repair with single-row technique |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged ≥45 years with a diagnosis of full-thickness rotator cuff injury <2cm
- Arthroscopic rotator cuff repair surgery with single row or double row suture bridge
- Follow-up > 24 months
- Completeness of clinical-radiographic documentation
- Patients at first rotator cuff repair surgery on affected side
Key exclusion criteria (8 listed)
- Patients with associated injuries to the affected upper limb
- Patients with neuromuscular disorders, or established psychomotor disorders
- Patients with associated injuries of the subscapularis muscle tendon
- Patients with a history of previous surgery of the affected shoulder
- Patients with massive rotator cuff injury > 2cm
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 |
|---|---|---|
| rotatori cuff repairrotatori cuff repair | Procedure or surgery | DOUBLE-ROW, SINGLE-ROW |
Primary outcome
radiological outcome (Sugaya score)
Time frame: 24 months
The Sugaya classification is used to evaluate rotator cuff repair, assessing post-operative rotator cuff repair on oblique coronal, oblique sagittal and transverse MRI planes. Scores range from 0 to 5 with a score of 0 indicating better tendon quality and no lesion and 5 indicating worse tendon quality with complete lesion.
clinical outcome (American Shoulder and Elbow Surgeons shoulder score)
Time frame: 24 months
ASES score is designed to assess the condition of the shoulder, regardless of disease pathology, requiring both a physician assessment and a patient-completed portion. Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.
clinical outcome (University of California and Los Angeles shoulder score)
Time frame: 24 months
UCLA shoulder score is a jointly completed score, with both physician and patient completed portions. Scores range from 0 to 35 with a score of 0 indicating worse shoulder function and 35 indicating better shoulder function.
clinical outcome (Costant-Murley score)
Time frame: 24 months
The Costant-Murley score is designed to assess the functional state of a normal, a diseased, or a treated shoulder. It contains both physician-completed and patient-reported portions. Scores range from 0 points (most disability) to 100 points (least disability).
clinical outcome (Range Of Motion)
Time frame: 24 months
ROM expresses in degrees the degree of range of motion that a joint can perform along its full range of motion whether active or passive through an external aid.
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 18 Jun 2024.
- Results publication: PubMed 30828184Khoriati AA, Antonios T, Gulihar A, Singh B. Single Vs Double row repair in rotator cuff tears - A review and analysis of current evidence. J Clin Orthop Trauma. 2019 Mar-Apr;10(2):236-240. doi: 10.1016/j.jcot.2019.01.027. Epub 2019 Jan 30. No abstract available.
- Results publication: PubMed 20383686Padua R, Padua L, Ceccarelli E, Bondi R, Alviti F, Castagna A. Italian version of ASES questionnaire for shoulder assessment: cross-cultural adaptation and validation. Musculoskelet Surg. 2010 May;94 Suppl 1:S85-90. doi: 10.1007/s12306-010-0064-9.
- Results publication: PubMed 16325080Sugaya H, Maeda K, Matsuki K, Moriishi J. Functional and structural outcome after arthroscopic full-thickness rotator cuff repair: single-row versus dual-row fixation. Arthroscopy. 2005 Nov;21(11):1307-16. doi: 10.1016/j.arthro.2005.08.011.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rotatori cuff repair in people with Cuff Injury, Rotator, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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 8 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 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
radiological outcome (Sugaya score) (time frame: 24 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06059625, which also lists 3 linked publications.
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 18 Jun 2024.