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Cutting-through at the Greater Tuberosity

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ClinicalTrials.gov Identifier: NCT04587180
Recruitment Status : Completed
First Posted : October 14, 2020
Last Update Posted : October 19, 2020
Sponsor:
Collaborator:
Hallym University
Information provided by (Responsible Party):
Jung-Taek Hwang, Chuncheon Sacred Heart Hospital

Study Description
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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.

Condition or disease Intervention/treatment
Rotator Cuff Tears Procedure: Arthroscopic suture-bridge rotator cuff repair

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
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Study Type : Observational
Actual Enrollment : 95 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : June 1, 2014
Actual Primary Completion Date : October 31, 2015
Actual Study Completion Date : December 31, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals Tears

Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients with cutting-through
Patients who had cutting-through during the lateral knotless anchor fixation.
 Procedure: Arthroscopic suture-bridge rotator cuff repair
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.
 Procedure: Arthroscopic suture-bridge rotator cuff repair
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. Hip bone mineral density [ Time Frame: preoperatively ]
    Measured by using standard techniques according to the manufacturer and the International Society for Clinical Densitometry guidelines.


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with arthroscopic rotator cuff suture-bridge repair for full-thickness rotator cuff tears
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04587180


Sponsors and Collaborators
Chuncheon Sacred Heart Hospital
Hallym University
Investigators
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Principal Investigator: Jung-Taek Hwang, MD, PhD Chuncheon Sacred Heart Hospital
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jung-Taek Hwang, Associate Professor, Chuncheon Sacred Heart Hospital
ClinicalTrials.gov Identifier: NCT04587180    
Other Study ID Numbers: 2014-33
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Keywords provided by Jung-Taek Hwang, Chuncheon Sacred Heart Hospital:
rotator cuff tear
cutting-through
Bone mineral density
suture-bridge repair
Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries