Rotator Cuff TearsNCT07769554
Longitudinal Change in Depression Severity and Clinical Outcomes After Arthroscopic Rotator Cuff Repair
An observational study of Rotator Cuff Tears and Depressive Symptoms, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.
Trial summary
This prospective cohort study evaluated how depressive symptom severity changes during the first 2 years after arthroscopic rotator cuff repair, and whether changes in depressive symptoms are associated with improvements in shoulder pain and function. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rotator Cuff Tears, Depressive Symptoms
- What is being tested?
- Arthroscopic suture-bridge rotator cuff repair
- Type of treatment
- Surgery or procedure
- How many people
- 84 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Feb 2013to 31 Jan 2017
- How long will I take part?
- 2 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults who underwent primary arthroscopic suture-bridge repair for a symptomatic full-thickness rotator cuff tear at a single tertiary referral hospital in the Republic of Korea between February 2013 and January 2015.
Who may be able to join
- Primary arthroscopic suture-bridge repair for a symptomatic full-thickness rotator cuff tear identified on preoperative MRI
- Assessment of depressive symptom severity with the Hamilton Depression Rating Scale within 2 weeks before surgery
- Willingness to complete scheduled follow-up assessments, including HDRS and clinical scores at 3, 6, 12, and 24 months and shoulder ultrasonography at 24 months after surgery
Who cannot join
- Partial-thickness rotator cuff tear or isolated subscapularis tear
- Revision rotator cuff surgery
- Shoulder instability
- Glenohumeral osteoarthritis
- Neurologic or systemic disease affecting the shoulder joint
- History of acute trauma or infection
- Incomplete medical records
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, Gangwon-do, 24258
About this study
Official title: Longitudinal Change in Depression Severity and Its Association With Clinical Outcomes After Arthroscopic Rotator Cuff Repair: A Prospective Cohort Study
This prospective cohort study evaluated how depressive symptom severity changes during the first 2 years after arthroscopic rotator cuff repair, and whether changes in depressive symptoms are associated with improvements in shoulder pain and function. Adults who underwent arthroscopic suture-bridge repair for a symptomatic full-thickness rotator cuff tear were classified by preoperative Hamilton Depression Rating Scale (HDRS) score as having depressive symptoms (HDRS ≥8) or not (HDRS ≤7). Depressive symptom severity (HDRS), shoulder pain (visual analog scale), and shoulder function (American Shoulder and Elbow Surgeons score and Constant score) were assessed before surgery and at 3, 6, 12, and 24 months after surgery. Integrity of the repaired tendon was evaluated with ultrasonography at 24 months.
- Conditions
- Rotator Cuff Tears, Depressive Symptoms
- Being tested
- Arthroscopic suture-bridge rotator cuff repair
- Keywords
- rotator cuff repair, arthroscopy, depression, Hamilton Depression Rating Scale
- Medical subject headings
- Rotator Cuff Injuries, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic suture-bridge rotator cuff repairProcedure or surgery
Arthroscopic repair of a full-thickness rotator cuff tear using a suture-bridge technique with medial-row suture anchors and lateral-row knotless anchors, performed as standard care in all participants
| Study group | Role | What they receive |
|---|---|---|
| Preoperative depressive symptoms (HDRS ≥8) | Patients with a preoperative Hamilton Depression Rating Scale score of 8 or higher, assessed within 2 weeks before surgery Receives: Procedure: Arthroscopic suture-bridge rotator cuff repair | |
| No preoperative depressive symptoms (HDRS ≤7) | Patients with a preoperative Hamilton Depression Rating Scale score of 7 or lower Receives: Procedure: Arthroscopic suture-bridge rotator cuff repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hamilton Depression Rating Scale (HDRS) Score
Clinician-administered rating scale of depressive symptom severity; higher scores indicate more severe depressive symptoms. A score of 8 or higher was defined as the presence of depressive symptoms.
Measured: Preoperatively (within 2 weeks before surgery) and at 3, 6, 12, and 24 months after surgery
Secondary outcomes (4)
Visual Analog Scale (VAS) Score for Pain
Score range 0-10; higher scores indicate more severe pain.
Measured: Preoperatively (within 2 weeks before surgery) and at 3, 6, 12, and 24 months after surgery
American Shoulder and Elbow Surgeons (ASES) Score
Score range 0-100; higher scores indicate better shoulder function.
Measured: Preoperatively (within 2 weeks before surgery) and at 3, 6, 12, and 24 months after surgery
Constant Score
Score range 0-100; higher scores indicate better shoulder function.
Measured: Preoperatively (within 2 weeks before surgery) and at 3, 6, 12, and 24 months after surgery
Retear of the Repaired Rotator Cuff on Ultrasonography
Retear was defined as complete discontinuity of the repaired rotator cuff tendon on ultrasonography.
Measured: 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start1 Feb 2013
- Primary completion31 Jan 2017
- Study completion31 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- 84 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Chuncheon Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hallym University Medical Center
- Responsible party
- Principal investigator, Jung-Taek Hwang, Chuncheon Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07769554
- Sponsor's protocol ID
- 2013-9
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the informed consent obtained at the time of enrollment did not include provisions for sharing de-identified individual-level data with third parties.
Publications
Potter MQ, Wylie JD, Greis PE, Burks RT, Tashjian RZ. Psychological distress negatively affects self-assessment of shoulder function in patients with rotator cuff tears. Clin Orthop Relat Res. 2014 Dec;472(12):3926-32. doi: 10.1007/s11999-014-3833-1. Epub 2014 Jul 31.
PubMed 25080266Johnson AH, York JJ, Lashgari CJ, Petre BM, Turcotte JJ, Redziniak DE. Effects of preexisting depression and anxiety on postoperative outcomes following arthroscopic rotator cuff repair. JSES Int. 2022 Aug 10;6(6):984-988. doi: 10.1016/j.jseint.2022.07.005. eCollection 2022 Nov.
PubMed 36353422Cho CH, Seo HJ, Bae KC, Lee KJ, Hwang I, Warner JJ. The impact of depression and anxiety on self-assessed pain, disability, and quality of life in patients scheduled for rotator cuff repair. J Shoulder Elbow Surg. 2013 Sep;22(9):1160-6. doi: 10.1016/j.jse.2013.02.006. Epub 2013 Apr 14.
PubMed 23594716Baker M, Albelo F, Zhang T, Schneider MB, Foster MJ, Aneizi A, Hasan SA, Gilotra MN, Henn RF 3rd. PROMIS Depression and Anxiety in shoulder surgery patients. Bone Joint J. 2022 Apr;104-B(4):479-485. doi: 10.1302/0301-620X.104B4.BJJ-2021-1089.R1.
PubMed 35360950
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Change in Depression Severity and Its Association With Clinical Outcomes After Arthroscopic Rotator Cuff Repair: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07769554
- Acronym / sponsor ID
- 2013-9
- Conditions
- Rotator Cuff Tears, Depressive Symptoms
- Keywords
- rotator cuff repair, arthroscopy, depression, Hamilton Depression Rating Scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Chuncheon Sacred Heart HospitalUniversity, hospital or other
- Collaborators
- Hallym University Medical Center
- Study start
- 1 Feb 2013 (actual)
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 31 Jan 2017 (actual)
- First posted
- 18 Aug 2026 (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.
This prospective cohort study evaluated how depressive symptom severity changes during the first 2 years after arthroscopic rotator cuff repair, and whether changes in depressive symptoms are associated with improvements in shoulder pain and function. Adults who underwent arthroscopic suture-bridge repair for a symptomatic full-thickness rotator cuff tear were classified by preoperative Hamilton Depression Rating Scale (HDRS) score as having depressive symptoms (HDRS ≥8) or not (HDRS ≤7). Depressive symptom severity (HDRS), shoulder pain (visual analog scale), and shoulder function (American Shoulder and Elbow Surgeons score and Constant score) were assessed before surgery and at 3, 6, 12, and 24 months after surgery. Integrity of the repaired tendon was evaluated with ultrasonography at 24 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative depressive symptoms (HDRS ≥8) | – | Procedure: Arthroscopic suture-bridge rotator cuff repairPatients with a preoperative Hamilton Depression Rating Scale score of 8 or higher, assessed within 2 weeks before surgery |
| No preoperative depressive symptoms (HDRS ≤7) | – | Procedure: Arthroscopic suture-bridge rotator cuff repairPatients with a preoperative Hamilton Depression Rating Scale score of 7 or lower |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults who underwent primary arthroscopic suture-bridge repair for a symptomatic full-thickness rotator cuff tear at a single tertiary referral hospital in the Republic of Korea between February 2013 and January 2015.
Key inclusion criteria (3 listed)
- Primary arthroscopic suture-bridge repair for a symptomatic full-thickness rotator cuff tear identified on preoperative MRI
- Assessment of depressive symptom severity with the Hamilton Depression Rating Scale within 2 weeks before surgery
- Willingness to complete scheduled follow-up assessments, including HDRS and clinical scores at 3, 6, 12, and 24 months and shoulder ultrasonography at 24 months after surgery
Key exclusion criteria (7 listed)
- Partial-thickness rotator cuff tear or isolated subscapularis tear
- Revision rotator cuff surgery
- Shoulder instability
- Glenohumeral osteoarthritis
- Neurologic or systemic disease affecting the shoulder joint
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 suture-bridge rotator cuff repairArthroscopic repair of a full-thickness rotator cuff tear using a suture-bridge technique with medial-row suture anchors and lateral-row knotless anchors, performed as standard care in all participants | Procedure or surgery | No preoperative depressive symptoms (HDRS ≤7), Preoperative depressive symptoms (HDRS ≥8) |
Primary outcome
Change in Hamilton Depression Rating Scale (HDRS) Score
Time frame: Preoperatively (within 2 weeks before surgery) and at 3, 6, 12, and 24 months after surgery
Clinician-administered rating scale of depressive symptom severity; higher scores indicate more severe depressive symptoms. A score of 8 or higher was defined as the presence of depressive symptoms.
4 secondary outcomes
Visual Analog Scale (VAS) Score for Pain
Time frame: Preoperatively (within 2 weeks before surgery) and at 3, 6, 12, and 24 months after surgery
American Shoulder and Elbow Surgeons (ASES) Score
Time frame: Preoperatively (within 2 weeks before surgery) and at 3, 6, 12, and 24 months after surgery
Constant Score
Time frame: Preoperatively (within 2 weeks before surgery) and at 3, 6, 12, and 24 months after surgery
Retear of the Repaired Rotator Cuff on Ultrasonography
Time frame: 24 months after surgery
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 Aug 2026.
- Background: PubMed 25080266Potter MQ, Wylie JD, Greis PE, Burks RT, Tashjian RZ. Psychological distress negatively affects self-assessment of shoulder function in patients with rotator cuff tears. Clin Orthop Relat Res. 2014 Dec;472(12):3926-32. doi: 10.1007/s11999-014-3833-1. Epub 2014 Jul 31.
- Background: PubMed 36353422Johnson AH, York JJ, Lashgari CJ, Petre BM, Turcotte JJ, Redziniak DE. Effects of preexisting depression and anxiety on postoperative outcomes following arthroscopic rotator cuff repair. JSES Int. 2022 Aug 10;6(6):984-988. doi: 10.1016/j.jseint.2022.07.005. eCollection 2022 Nov.
- Background: PubMed 23594716Cho CH, Seo HJ, Bae KC, Lee KJ, Hwang I, Warner JJ. The impact of depression and anxiety on self-assessed pain, disability, and quality of life in patients scheduled for rotator cuff repair. J Shoulder Elbow Surg. 2013 Sep;22(9):1160-6. doi: 10.1016/j.jse.2013.02.006. Epub 2013 Apr 14.
- Background: PubMed 35360950Baker M, Albelo F, Zhang T, Schneider MB, Foster MJ, Aneizi A, Hasan SA, Gilotra MN, Henn RF 3rd. PROMIS Depression and Anxiety in shoulder surgery patients. Bone Joint J. 2022 Apr;104-B(4):479-485. doi: 10.1302/0301-620X.104B4.BJJ-2021-1089.R1.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the informed consent obtained at the time of enrollment did not include provisions for sharing de-identified individual-level data with third parties.
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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?
An observational study of Rotator Cuff Tears and Depressive Symptoms, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.
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 7 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 Aug 2026. 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 South Korea. 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?
Change in Hamilton Depression Rating Scale (HDRS) Score (time frame: Preoperatively (within 2 weeks before surgery) and at 3, 6, 12, and 24 months after surgery). 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 NCT07769554, which also lists 4 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 Aug 2026.