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Clinical Trials/NCT04587180
NCT04587180CompletedNot Applicable

The Correlation Between the Bone Mineral Density of the Proximal Humerus and Cutting-through at the Greater Tuberosity in Arthroscopic Suture-bridge Rotator Cuff Repair

Chuncheon Sacred Heart Hospital0 sites95 target enrollmentStarted: June 1, 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
95
Primary Endpoint
Hip bone mineral density

Study Overview

Brief Summary

The investigators evaluated the correlation between cutting-through at the greater tuberosity (GT) just medial to the lateral knotless anchor in arthroscopic suture-bridge rotator cuff repair and the bone mineral density (BMD) of the lumbar spine, hip and GT of the proximal humerus and to evaluate factors and clinical outcomes related to cutting-through at the GT.

Detailed Description

Seventy-eight patients who underwent arthroscopic suture-bridge rotator cuff repair and who had undergone dual energy X-ray absorptiometry (DEXA) scans before surgery were included. Patients were divided into two groups: patients who had cutting-through (46, group I) and patients who did not (32, group II). Clinical and radiological data including demographics, BMDs, fatty infiltration of rotator cuff muscles, tear size, tear involvement, VAS pain score, and ASES score were analyzed.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
50 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Primary arthroscopic repair for a symptomatic full-thickness rotator cuff tear identified by preoperative MRI
  • Dual energy X-ray absorptiometry (DEXA) to evaluate the BMD of the lumbar spine and hip, as a standardized measurement, and the GT of the affected proximal humerus
  • Follow up for a minimum of 2 years after the primary surgery.

Exclusion Criteria

  • Primary arthroscopic repair due to partial-thickness rotator cuff tear or an isolated subscapularis tear
  • Primary suture-bridge repair with 3 or more lateral-knotless anchors
  • Previous history of fractures or surgeries on the affected shoulder
  • Shoulder instability
  • Glenohumeral osteoarthritis
  • Neurologic or systemic disease diseases influencing the shoulder joint 7 History of infection of the shoulder joint

Outcomes

Primary Outcomes

Hip bone mineral density

Time Frame: preoperatively

Measured by using standard techniques according to the manufacturer and the International Society for Clinical Densitometry guidelines.

Visual Analog Scale (VAS) Pain Score

Time Frame: 2 years after surgery

The VAS pain score was based on a scale from 0 to 10, where 0 indicated no pain and 10 indicated severe pain

American Shoulder and Elbow Surgeons (ASES) score

Time Frame: 2 years after surgery

American Shoulder and Elbow Surgeons score for estimating shoulder function was based on a score from 0 to 100, where 0 indicated poor outcome and 100 indicated excellent outcome.

The occurrence of cutting-through

Time Frame: During the surgery

The occurrence of cortical breakage of the GT just medial to the lateral knotless anchor hole due to the tension of the sutures from the medial anchor

Greater tuberosity bone mineral density

Time Frame: preoperatively

GT BMD was measured using the predefined region of interest (ROI). Dividing the humeral head into three columns of even width, we defined a 1x1-cm2-sized square in the center of the lateral column as ROI.

Lumbar spine bone mineral density

Time Frame: preoperatively

Measured by using standard techniques according to the manufacturer and the International Society for Clinical Densitometry guidelines.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Chuncheon Sacred Heart Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jung-Taek Hwang

Associate Professor

Chuncheon Sacred Heart Hospital

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