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CompletedNCT07769554Updated Aug 18, 2026

Longitudinal Change in Depression Severity and Clinical Outcomes After Arthroscopic Rotator Cuff Repair

An observational study in Rotator Cuff Tears and Depressive Symptoms, sponsored by Chuncheon Sacred Heart Hospital. Completed at 1 site in South Korea. Per ClinicalTrials.gov, last updated 2026-08-18.

Sponsored by Chuncheon Sacred Heart Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
84
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Rotator Cuff Tears
  • Depressive Symptoms

Keywords

  • rotator cuff repair
  • arthroscopy
  • depression
  • Hamilton Depression Rating Scale
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
84 participants (actual)
Target follow-up
2 Years
Patient registry
Yes

Groups and cohorts

  • Preoperative depressive symptoms (HDRS ≥8)

    Patients with a preoperative Hamilton Depression Rating Scale score of 8 or higher, assessed within 2 weeks before surgery

    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

    Procedure: Arthroscopic suture-bridge rotator cuff repair

Interventions

  • ProcedureArthroscopic suture-bridge rotator cuff repair

    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

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Preoperatively (within 2 weeks before surgery) and at 3, 6, 12, and 24 months after surgery

Secondary outcomes

  1. Visual Analog Scale (VAS) Score for Pain

    Score range 0-10; higher scores indicate more severe pain.

    Time frame: Preoperatively (within 2 weeks before surgery) and at 3, 6, 12, and 24 months after surgery

  2. American Shoulder and Elbow Surgeons (ASES) Score

    Score range 0-100; higher scores indicate better shoulder function.

    Time frame: Preoperatively (within 2 weeks before surgery) and at 3, 6, 12, and 24 months after surgery

  3. Constant Score

    Score range 0-100; higher scores indicate better shoulder function.

    Time frame: Preoperatively (within 2 weeks before surgery) and at 3, 6, 12, and 24 months after surgery

  4. Retear of the Repaired Rotator Cuff on Ultrasonography

    Retear was defined as complete discontinuity of the repaired rotator cuff tendon on ultrasonography.

    Time frame: 24 months after surgery

06

Study locations

1 site
  • Hallym University Chuncheon Sacred Heart Hospital
    Chuncheon, Gangwon-do 24258, South Korea
07

References and documents

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 25080266 ↗
  • Johnson 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 36353422 ↗
  • Cho 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 23594716 ↗
  • Baker 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 ↗

Individual participant data

Plan to share: 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.

08

Registry details

Key details

Study ID
NCT07769554
Lead sponsor
Chuncheon Sacred Heart Hospital
Collaborators
Hallym University Medical Center
Responsible party
Jung-Taek Hwang (Professor, Department of Orthopedic Surgery, Chuncheon Sacred Heart Hospital) — Principal investigator
First posted
Aug 18, 2026
Start date
Feb 1, 2013
Primary completion
Jan 31, 2017
Completion
Jan 31, 2017
Last update
Aug 18, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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