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Completed

NCT Number: NCT04587180

Cutting-through at the Greater Tuberosity

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.

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Key information

Conditions

Rotator Cuff Tears Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arthroscopic suture-bridge rotator cuff repair

Procedure

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.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Chuncheon Sacred Heart Hospital

Other

Collaborators

  • Hallym University

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 14, 2020
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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