Cutting-through at the Greater Tuberosity

October 13, 2020 updated by: Jung-Taek Hwang, Chuncheon Sacred Heart Hospital

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

95

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with arthroscopic rotator cuff suture-bridge repair for full-thickness rotator cuff tears

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with cutting-through
Patients who had cutting-through during the lateral knotless anchor fixation.
Arthroscopic suture-bridge repair is a widely used and universal surgical method for symptomatic rotator cuff tear patients. It is arthroscopic surgery to reattach ruptured rotator cuff tendons to the original insertion (greater tuberosity) using medial and lateral row anchors.
Patients without cutting-through
Patients who didn't have cutting-through during the lateral knotless anchor fixation.
Arthroscopic suture-bridge repair is a widely used and universal surgical method for symptomatic rotator cuff tear patients. It is arthroscopic surgery to reattach ruptured rotator cuff tendons to the original insertion (greater tuberosity) using medial and lateral row anchors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During the surgery
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
2 years after surgery
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.
2 years after surgery
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.
preoperatively
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.
preoperatively
Hip bone mineral density
Time Frame: preoperatively
Measured by using standard techniques according to the manufacturer and the International Society for Clinical Densitometry guidelines.
preoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Jung-Taek Hwang, MD, PhD, Chuncheon Sacred Heart Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2014

Primary Completion (Actual)

October 31, 2015

Study Completion (Actual)

December 31, 2015

Study Registration Dates

First Submitted

October 7, 2020

First Submitted That Met QC Criteria

October 7, 2020

First Posted (Actual)

October 14, 2020

Study Record Updates

Last Update Posted (Actual)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 13, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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