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

NCT07769554 | Completed

• 1 other identifier: 2013-9
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rotator Cuff Tears; Depressive Symptoms

Keywords

rotator cuff repair; arthroscopy; depression; Hamilton Depression Rating Scale

Outcome Measures

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.

  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

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

• American Shoulder and Elbow Surgeons (ASES) Score

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

• Constant Score

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

• Retear of the Repaired Rotator Cuff on Ultrasonography

  24 months after surgery

Study Arms (2)

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

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

No preoperative depressive symptoms (HDRS ≤7); Preoperative depressive symptoms (HDRS ≥8)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chuncheon Sacred Heart Hospital: lead
• Hallym University Medical Center: collaborator

Study Sites (1)

Hallym University Chuncheon Sacred Heart Hospital

Chuncheon, Gangwon-do, 24258, South Korea

Location

Related Publications (4)

• 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.

  PMID: 25080266 BACKGROUND

• 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.

  PMID: 36353422 BACKGROUND

• 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.

  PMID: 23594716 BACKGROUND

• 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.

  PMID: 35360950 BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries; Depression

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Behavioral Symptoms; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Orthopedic Surgery

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: August 18, 2026
• Study Start: February 1, 2013
• Primary Completion: January 31, 2017
• Study Completion: January 31, 2017
• Last Updated: August 18, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)