Rotator Cuff TearsNCT05477771
The Cross-sectional Area of the Long Head of the Biceps Tendon and the Rotator Cuff Tear Position
A study testing Arthroscopic rotator cuff repair in people with Rotator Cuff Tears, run by RenJi Hospital.
Trial summary
The main aim and scope of this study is making measurement and comparison of the cross-sectional area of the long head of the biceps tendon(LHBT) in the patients suffered form rotator cuff tear with different tear positions, and making observation and comparison of the impairment type of the LHBT in the patients… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Arthroscopic rotator cuff repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 29 Jul 2022to 22 Aug 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- partial or full-thickness but reparable rotator cuff tear;
- small- to large-sized rotator cuff tears being defined by DeOrio and Cofied4;
- no improvements after at least 1 month of conservative treatment such as NSAIDs or corticosteroid injection.
Who cannot join
- massive rotator cuff tears being defined by DeOrio and Cofied;
- patients with osteoarthritis of the glenohumeral joint;
- trauma or a history of surgery at the shoulder.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Correlation Between the Cross-sectional Area of the Long Head of the Biceps Tendon and the Tear Position in Patients With Rotator Cuff Tears
The main aim and scope of this study is making measurement and comparison of the cross-sectional area of the long head of the biceps tendon(LHBT) in the patients suffered form rotator cuff tear with different tear positions, and making observation and comparison of the impairment type of the LHBT in the patients suffered from rotator cuff tear with different tear positions. The results may identify the influence of the tear position on the LHBT.
- Conditions
- Rotator Cuff Tears
- Being tested
- Arthroscopic rotator cuff repair
- Keywords
- long head of the bicep tendon, rotator cuff tear, cross-sectional area
- 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.
Arthroscopic rotator cuff repairProcedure or surgery
The rotator cuff tears were repaired under arthroscopy. A subacromial decompression was performed in all patients. Then the long head of the biceps with severe lesions were treated by tenotomy while the others were reserved according to the surgeon's judgment during the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Anterior tear group | Experimental | The rotator cuff was divided into three parts according to the arthroscopic discovery: (1) the anterior part which contained the subsacpularis and one third of the suprascapularis forward; (2) the middle part which contained the two thirds of the suprascapularis backward and one third of the subscapularis forward; (3) the posterior part which contained two thirds of subscapularis backward and teres minor. The patients with rotator cuff tear at the anterior part were categorized in the anterior tear group. Receives: Procedure: Arthroscopic rotator cuff repair |
| Middle tear group | Experimental | The rotator cuff was divided into three parts according to the arthroscopic discovery: (1) the anterior part which contained the subsacpularis and one third of the suprascapularis forward; (2) the middle part which contained the two thirds of the suprascapularis backward and one third of the subscapularis forward; (3) the posterior part which contained two thirds of subscapularis backward and teres minor. The patients with rotator cuff tear at the middle part were categorized in the middle tear group. Receives: Procedure: Arthroscopic rotator cuff repair |
| Posterior tear group | Experimental | The rotator cuff was divided into three parts according to the arthroscopic discovery: (1) the anterior part which contained the subsacpularis and one third of the suprascapularis forward; (2) the middle part which contained the two thirds of the suprascapularis backward and one third of the subscapularis forward; (3) the posterior part which contained two thirds of subscapularis backward and teres minor. The patients with rotator cuff tear at the posterior part were categorized in the posterior tear group. Receives: Procedure: Arthroscopic rotator cuff repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-operative measurement of the cross-sectional area of the long head of bicep tendon
According to the pre-operative MRI scan, two sites of the long head of biceps tendon were measured by the Image-Pro Plus 6.0 software. One was the plane that passed the center of the glenoid cavity, the other one was the plane that passed the distal border of the glenoid cavity. The contour of the long head of biceps tendon was traced and the area was calculated by the software according to the MRI's scale.
Measured: Pre-operative
Secondary outcomes (1)
Post-operative measurement of the cross-sectional area of the long head of bicep
According to the MRI scan 2 months after the surgery, two sites of the long head of biceps tendon were measured by the Image-Pro Plus 6.0 software. One was the plane that passed the center of the glenoid cavity, the other one was the plane that passed the distal border of the glenoid cavity. The contour of the long head of biceps tendon was traced and the area was calculated by the software according to the MRI's scale.
Measured: 2 months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start29 Jul 2022 (estimated)
- Primary completion15 Aug 2022 (estimated)
- Study completion22 Aug 2022 (estimated)
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.
- More trials run by RenJi HospitalThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lin Du, Study chair, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05477771
- Sponsor's protocol ID
- IIT-2022-0028
- Status last verified
- Jul 2022
- First submitted
- 25 Jul 2022
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between the Cross-sectional Area of the Long Head of the Biceps Tendon and the Tear Position in Patients With Rotator Cuff Tears
- ClinicalTrials.gov ID
- NCT05477771
- Acronym / sponsor ID
- IIT-2022-0028
- Conditions
- Rotator Cuff Tears
- Keywords
- long head of the bicep tendon, rotator cuff tear, cross-sectional area
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 29 Jul 2022 (estimated)
- Primary completion
- 15 Aug 2022 (estimated)
- Study completion
- 22 Aug 2022 (estimated)
- First posted
- 28 Jul 2022 (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 main aim and scope of this study is making measurement and comparison of the cross-sectional area of the long head of the biceps tendon(LHBT) in the patients suffered form rotator cuff tear with different tear positions, and making observation and comparison of the impairment type of the LHBT in the patients suffered from rotator cuff tear with different tear positions. The results may identify the influence of the tear position on the LHBT.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anterior tear group | Experimental | Procedure: Arthroscopic rotator cuff repairThe rotator cuff was divided into three parts according to the arthroscopic discovery: (1) the anterior part which contained the subsacpularis and one third of the suprascapularis forward; (2) the middle part which contained the two thirds of the suprascapularis backward and one third of the subscapularis forward; (3) the posterior part which contained two thirds of subscapularis backward and teres minor. The patients with rotator cuff tear at the anterior part were categorized in the anterior tear group. |
| Middle tear group | Experimental | Procedure: Arthroscopic rotator cuff repairThe rotator cuff was divided into three parts according to the arthroscopic discovery: (1) the anterior part which contained the subsacpularis and one third of the suprascapularis forward; (2) the middle part which contained the two thirds of the suprascapularis backward and one third of the subscapularis forward; (3) the posterior part which contained two thirds of subscapularis backward and teres minor. The patients with rotator cuff tear at the middle part were categorized in the middle tear group. |
| Posterior tear group | Experimental | Procedure: Arthroscopic rotator cuff repairThe rotator cuff was divided into three parts according to the arthroscopic discovery: (1) the anterior part which contained the subsacpularis and one third of the suprascapularis forward; (2) the middle part which contained the two thirds of the suprascapularis backward and one third of the subscapularis forward; (3) the posterior part which contained two thirds of subscapularis backward and teres minor. The patients with rotator cuff tear at the posterior part were categorized in the posterior tear group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- partial or full-thickness but reparable rotator cuff tear;
- small- to large-sized rotator cuff tears being defined by DeOrio and Cofied4;
- no improvements after at least 1 month of conservative treatment such as NSAIDs or corticosteroid injection.
Key exclusion criteria (3 listed)
- massive rotator cuff tears being defined by DeOrio and Cofied;
- patients with osteoarthritis of the glenohumeral joint;
- trauma or a history of surgery at the 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 |
|---|---|---|
| Arthroscopic rotator cuff repairThe rotator cuff tears were repaired under arthroscopy. A subacromial decompression was performed in all patients. Then the long head of the biceps with severe lesions were treated by tenotomy while the others were reserved according to the surgeon's judgment during the surgery. | Procedure or surgery | Anterior tear group, Middle tear group, Posterior tear group |
Primary outcome
Pre-operative measurement of the cross-sectional area of the long head of bicep tendon
Time frame: Pre-operative
According to the pre-operative MRI scan, two sites of the long head of biceps tendon were measured by the Image-Pro Plus 6.0 software. One was the plane that passed the center of the glenoid cavity, the other one was the plane that passed the distal border of the glenoid cavity. The contour of the long head of biceps tendon was traced and the area was calculated by the software according to the MRI's scale.
1 secondary outcome
Post-operative measurement of the cross-sectional area of the long head of bicep
Time frame: 2 months after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- 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.
Lin Du study chair
RenJi Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic rotator cuff repair in people with Rotator Cuff Tears, run by RenJi Hospital.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin Du (86-13817371926, sato316@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-operative measurement of the cross-sectional area of the long head of bicep tendon (time frame: Pre-operative). 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 28 Jul 2022.