Supraspinatus TearNCT07311616
A Study on the Effectiveness of Preventive Extensive Release of the Rotator Interval and Joint Capsule to Reduce Postoperative Stiffness in Arthroscopic Rotator Cuff Repair
A study testing Prophylactic extensive shoulder release and capsular release and Arthroscopic rotator cuff repair in people with Supraspinatus Tear, run by Beijing Jishuitan Hospital at 1 site in China.
Trial summary
The incidence of rotator cuff injuries is high, especially among the elderly. With the aging of the population, the number of surgical patients has increased significantly. However, in the early stage after arthroscopic rotator cuff repair, a considerable proportion of patients are troubled by shoulder joint… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Supraspinatus Tear
- What is being tested?
- Prophylactic extensive shoulder release and capsular release and Arthroscopic rotator cuff repair
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 22 Dec 2025to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Medium to small-sized (tear size <3 cm) full-thickness supraspinatus muscle tears
- There was no shoulder joint stiffness before the operation. The range of motion of the joint was at least 160° for passive forward flexion under ROM anesthesia, 60° for external rotation when abduction was 0°, and equal to or greater than 60° for passive internal rotation at the level of the 10th thoracic vertebra
- About to undergo ARCR
- No history of trauma
- Patient consent to participate
Who cannot join
- There was a history of previous surgery on the ipsilateral shoulder
- Other injuries or lesions of the ipsilateral shoulder (such as glenohumeral arthritis, combined acromioclavicular joint dislocation, brachial plexus injury, etc.)
- It can not be completely repaired or even repaired during operation
- Have uncontrolled epilepsy or psychological illness
- Patients who were assessed as not suitable for inclusion in the study group
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Jishuitan Hospital
Beijing, Beijing Municipality, 100000
Yiming Zhu, 86-13693245245, zhu_yiming@hotmail.com
About this study
The incidence of rotator cuff injuries is high, especially among the elderly. With the aging of the population, the number of surgical patients has increased significantly. However, in the early stage after arthroscopic rotator cuff repair, a considerable proportion of patients are troubled by shoulder joint stiffness, which greatly affects the quality of life and satisfaction of patients after the operation. Despite this, there is still a lack of clear evidence-based medical evidence regarding whether preventive extensive shoulder release and joint capsule release during arthroscopic rotator cuff repair can effectively prevent or alleviate postoperative shoulder stiffness. To clarify this clinical issue, this project intends to conduct a single-blind randomized controlled trial (RCT). Before the operation, patients will be randomly divided into two groups under blinding conditions: the experimental group will receive arthroscopic rotator cuff repair surgery along with preventive extensive shoulder joint release and joint capsule release, while the control group will only receive arthroscopic rotator cuff repair surgery. After the operation, the investigators will conduct follow-up visits for 3 months, 6 months and 12 months for the two groups of patients, and perform magnetic resonance imaging (MRI) at the 12th month to assess the healing of the rotator cuff tendons. ASES score, Constant-Murley score, Visual Analogue Scale (VAS) pain score and active range (ROM) assessment were conducted before the operation and at the follow-up at 3 months, 6 months and 12 months after the operation. The occurrence of postoperative complications of the patients was counted at the last follow-up. Through this study, the investigators expect to provide scientific and effective guidance for the prevention of postoperative adhesions of the shoulder joint.
- Conditions
- Supraspinatus Tear
- Being tested
- Prophylactic extensive shoulder release and capsular release, Arthroscopic rotator cuff repair
- Keywords
- Rotator cuff repair, Postoperative stiffness, Joint capsule release, Randomized controlled trial, Range of motion of the shoulder joint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic extensive shoulder release and capsular releaseProcedure or surgery
Before rotator cuff repair, extensive release of the rotator cuff space is performed first, as well as comprehensive release of the middle glenohumeral ligament, inferior glenohumeral ligament, coracohumeral ligament, the area around the subscapularis tendon, the subacromial capsule, and the anterior and posterior inferior joint capsules.
Arthroscopic rotator cuff repairProcedure or surgery
Arthroscopic rotator cuff repair surgery
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The experimental group underwent arthroscopic rotator cuff repair combined with preventive extensive shoulder release and capsular release simultaneously. Receives: Procedure: Prophylactic extensive shoulder release and capsular release; Procedure: Arthroscopic rotator cuff repair |
| Control Group | Other | The control group only received arthroscopic rotator cuff repair surgery. Receives: Procedure: Arthroscopic rotator cuff repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Pain and Daily Functional Evaluation Measured By American Shoulder and Elbow Surgeons Score (ASES Questionnaire)
This outcome measure will be assessed using the American Shoulder and Elbow Surgeons Score (ASES), a disease-specific patient-reported outcome questionnaire. The scale consists of two key dimensions: pain (50 points, measured by Visual Analog Scale) and daily living functions (50 points, evaluating 10 activities including dressing, combing hair, and using the toilet). The total score ranges from 0 to 100, with higher scores indicating better shoulder function and less pain.
Measured: At baseline and at 3, 6 and 12 months after the operation.
Secondary outcomes (4)
Shoulder Function Measured By Constant-Murley Score
The Constant - Murley Score is a validated scale developed in 1986 for evaluating shoulder joint function, consisting of four assessment dimensions. It includes pain level (15 points), daily living activities (20 points), shoulder range of motion (40 points), and muscle strength (25 points), with a total score of 0 - 100. A higher score indicates better shoulder joint function. The subjective parts (pain and daily living activities) are completed by subjects themselves, while the objective parts (range of motion and muscle strength) are evaluated and recorded by researchers.
Measured: At baseline and at 3, 6 and 12 months after the operation.
Patient-Reported Shoulder Pain Intensity Measured by Visual Analogue Scale (0-10 Scale)
This outcome measure evaluates the intensity of shoulder pain in patients with supraspinatus muscle tear. A 100mmVAS ruler is used as the measurement tool (0mm= no pain, 100mm= extreme pain) to measure the intensity of shoulder pain in participants at baseline, 1 day after operation, 3 months, 6 months and 12 months of follow-up. Record the changes in VAS scores from baseline to each time point to reflect the intervention effect.The Visual Analogue Scale ranges from a minimum of 0 to a maximum of 10, and the higher the score, the worse the result.
Measured: At Basline, 1 day after the operation, and 3, 6, and 12 months after the operation
Range of Motion (ROM)
Postural photos were taken to measure the Angle of joint movement
Measured: At baseline and at 3, 6, and 12 months after operation
Rate of Postoperative Complications
Inquire about the medical history to identify postoperative complications in paticipants.
Measured: At 6 weeks, 3 months, 6 months and 12 months after the operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start22 Dec 2025 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supraspinatus TearStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Jishuitan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07311616
- Sponsor's protocol ID
- MR-11-25-079098
- Status last verified
- Nov 2025
- First submitted
- 30 Nov 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will provide de-identified individual participant data, study protocols, statistical analysis plans, and summaries of clinical study reports. These data include all variables analyzed in the primary and secondary outcome measures.
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Effectiveness of Preventive Extensive Release of the Rotator Interval and Joint Capsule to Reduce Postoperative Stiffness in Arthroscopic Rotator Cuff Repair
- ClinicalTrials.gov ID
- NCT07311616
- Acronym / sponsor ID
- MR-11-25-079098
- Conditions
- Supraspinatus Tear
- Keywords
- Rotator cuff repair, Postoperative stiffness, Joint capsule release, Randomized controlled trial, Range of motion of the shoulder joint
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Beijing Jishuitan HospitalUniversity, hospital or other
- Study start
- 22 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 31 Dec 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 incidence of rotator cuff injuries is high, especially among the elderly. With the aging of the population, the number of surgical patients has increased significantly. However, in the early stage after arthroscopic rotator cuff repair, a considerable proportion of patients are troubled by shoulder joint stiffness, which greatly affects the quality of life and satisfaction of patients after the operation. Despite this, there is still a lack of clear evidence-based medical evidence regarding whether preventive extensive shoulder release and joint capsule release during arthroscopic rotator cuff repair can effectively prevent or alleviate postoperative shoulder stiffness. To clarify this clinical issue, this project intends to conduct a single-blind randomized controlled trial (RCT). Before the operation, patients will be randomly divided into two groups under blinding conditions: the experimental group will receive arthroscopic rotator cuff repair surgery along with preventive extensive shoulder joint release and joint capsule release, while the control group will only receive arthroscopic rotator cuff repair surgery. After the operation, the investigators will conduct follow-up visits for 3 months, 6 months and 12 months for the two groups of patients, and perform magnetic resonance imaging (MRI) at the 12th month to assess the healing of the rotator cuff tendons. ASES score, Constant-Murley score, Visual Analogue Scale (VAS) pain score and active range (ROM) assessment were conducted before the operation and at the follow-up at 3 months, 6 months and 12 months after the operation. The occurrence of postoperative complications of the patients was counted at the last follow-up. Through this study, the investigators expect to provide scientific and effective guidance for the prevention of postoperative adhesions of the shoulder joint.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Procedure: Prophylactic extensive shoulder release and capsular release, Procedure: Arthroscopic rotator cuff repairThe experimental group underwent arthroscopic rotator cuff repair combined with preventive extensive shoulder release and capsular release simultaneously. |
| Control Group | Other | Procedure: Arthroscopic rotator cuff repairThe control group only received arthroscopic rotator cuff repair surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Medium to small-sized (tear size <3 cm) full-thickness supraspinatus muscle tears
- There was no shoulder joint stiffness before the operation. The range of motion of the joint was at least 160° for passive forward flexion under ROM anesthesia, 60° for external rotation when abduction was 0°, and equal to or greater than 60° for passive internal rotation at the level of the 10th thoracic vertebra
- About to undergo ARCR
- No history of trauma
- Patient consent to participate
Key exclusion criteria (5 listed)
- There was a history of previous surgery on the ipsilateral shoulder
- Other injuries or lesions of the ipsilateral shoulder (such as glenohumeral arthritis, combined acromioclavicular joint dislocation, brachial plexus injury, etc.)
- It can not be completely repaired or even repaired during operation
- Have uncontrolled epilepsy or psychological illness
- Patients who were assessed as not suitable for inclusion in the study group
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 |
|---|---|---|
| Prophylactic extensive shoulder release and capsular releaseBefore rotator cuff repair, extensive release of the rotator cuff space is performed first, as well as comprehensive release of the middle glenohumeral ligament, inferior glenohumeral ligament, coracohumeral ligament, the area around the subscapularis tendon, the subacromial capsule, and the anterior and posterior inferior joint capsules. | Procedure or surgery | Experimental Group |
| Arthroscopic rotator cuff repairArthroscopic rotator cuff repair surgery | Procedure or surgery | Control Group, Experimental Group |
Primary outcome
Shoulder Pain and Daily Functional Evaluation Measured By American Shoulder and Elbow Surgeons Score (ASES Questionnaire)
Time frame: At baseline and at 3, 6 and 12 months after the operation.
This outcome measure will be assessed using the American Shoulder and Elbow Surgeons Score (ASES), a disease-specific patient-reported outcome questionnaire. The scale consists of two key dimensions: pain (50 points, measured by Visual Analog Scale) and daily living functions (50 points, evaluating 10 activities including dressing, combing hair, and using the toilet). The total score ranges from 0 to 100, with higher scores indicating better shoulder function and less pain.
4 secondary outcomes
Shoulder Function Measured By Constant-Murley Score
Time frame: At baseline and at 3, 6 and 12 months after the operation.
Patient-Reported Shoulder Pain Intensity Measured by Visual Analogue Scale (0-10 Scale)
Time frame: At Basline, 1 day after the operation, and 3, 6, and 12 months after the operation
Range of Motion (ROM)
Time frame: At baseline and at 3, 6, and 12 months after operation
Rate of Postoperative Complications
Time frame: At 6 weeks, 3 months, 6 months and 12 months after the operation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: Yes. We will provide de-identified individual participant data, study protocols, statistical analysis plans, and summaries of clinical study reports. These data include all variables analyzed in the primary and secondary outcome measures.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prophylactic extensive shoulder release and capsular release and Arthroscopic rotator cuff repair in people with Supraspinatus Tear, run by Beijing Jishuitan Hospital at 1 site in China.
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 5 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: opening soon, as of the sponsor's last update on 31 Dec 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yiming Zhu (86-13693245245, zhu_yiming@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder Pain and Daily Functional Evaluation Measured By American Shoulder and Elbow Surgeons Score (ASES Questionnaire) (time frame: At baseline and at 3, 6 and 12 months after the operation.). 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 31 Dec 2025.