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NCT Number: NCT07769554

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

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.

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Key information

Conditions

Rotator Cuff Tears Behavior Behavioral Symptoms Depression Depressive Symptoms Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

Hallym University Chuncheon Sacred Heart Hospital

Chuncheon, Gangwon-do, 24258, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Arthroscopic suture-bridge rotator cuff repair

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

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

  2. 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

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

  3. Constant Score

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

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

  4. Retear of the Repaired Rotator Cuff on Ultrasonography

    Time frame: 24 months after surgery

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

Sponsors and collaborators

Lead sponsor

Chuncheon Sacred Heart Hospital

Other

Collaborators

  • Hallym University Medical Center

Registry information

Official study title

Longitudinal Change in Depression Severity and Its Association With Clinical Outcomes After Arthroscopic Rotator Cuff Repair: A Prospective Cohort Study

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Aug 18, 2026
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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