Cutting-through at the Greater Tuberosity

Completed

• Conditions: Rotator Cuff Tears
• Interventions: Procedure: Arthroscopic suture-bridge rotator cuff repair

• Registration Number: NCT04587180
• Lead Sponsor: Chuncheon Sacred Heart Hospital

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 Timeline

• Study Start: 2014-06-01
• Primary Completion: 2015-10-31
• Study Completion: 2015-12-31
• Status Verified: 2020-10
• Study First Submitted: 2020-10-07
• Study First Submitted QC: 2020-10-07
• Last Update Submitted: 2020-10-13
• Study First Posted: 2020-10-14
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

1. Primary arthroscopic repair for a symptomatic full-thickness rotator cuff tear identified by preoperative MRI
2. 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
3. Follow up for a minimum of 2 years after the primary surgery.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with cutting-through	Arthroscopic suture-bridge rotator cuff repair	Patients who had cutting-through during the lateral knotless anchor fixation.
Patients without cutting-through	Arthroscopic suture-bridge rotator cuff repair	Patients who didn't have cutting-through during the lateral knotless anchor fixation.

Primary Outcome Measures

Name	Time	Method
Hip bone mineral density	preoperatively	Measured by using standard techniques according to the manufacturer and the International Society for Clinical Densitometry guidelines.
Visual Analog Scale (VAS) Pain Score	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	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	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	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	preoperatively	Measured by using standard techniques according to the manufacturer and the International Society for Clinical Densitometry guidelines.