Cutting-through at the Greater Tuberosity

NCT ID: NCT04587180

Last Updated: 2020-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

95 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-01

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Rotator Cuff Tears

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with cutting-through

Patients who had cutting-through during the lateral knotless anchor fixation.

Arthroscopic suture-bridge rotator cuff repair

Intervention Type 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.

Patients without cutting-through

Patients who didn't have cutting-through during the lateral knotless anchor fixation.

Arthroscopic suture-bridge rotator cuff repair

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hallym University

OTHER

Sponsor Role collaborator

Chuncheon Sacred Heart Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jung-Taek Hwang

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jung-Taek Hwang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Chuncheon Sacred Heart Hospital

References

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Oh JH, Song BW, Lee YS. Measurement of volumetric bone mineral density in proximal humerus using quantitative computed tomography in patients with unilateral rotator cuff tear. J Shoulder Elbow Surg. 2014 Jul;23(7):993-1002. doi: 10.1016/j.jse.2013.09.024. Epub 2013 Dec 31.

Reference Type BACKGROUND
PMID: 24388151 (View on PubMed)

Oh JH, Song BW, Kim SH, Choi JA, Lee JW, Chung SW, Rhie TY. The measurement of bone mineral density of bilateral proximal humeri using DXA in patients with unilateral rotator cuff tear. Osteoporos Int. 2014 Nov;25(11):2639-48. doi: 10.1007/s00198-014-2795-1. Epub 2014 Jul 16.

Reference Type BACKGROUND
PMID: 25027108 (View on PubMed)

Pogorzelski J, Fritz EM, Horan MP, Katthagen JC, Hussain ZB, Godin JA, Millett PJ. Minimum Five-year Outcomes and Clinical Survivorship for Arthroscopic Transosseous-equivalent Double-row Rotator Cuff Repair. J Am Acad Orthop Surg. 2019 Dec 15;27(24):e1093-e1101. doi: 10.5435/JAAOS-D-18-00519.

Reference Type BACKGROUND
PMID: 31805019 (View on PubMed)

Ono Y, Woodmass JM, Nelson AA, Boorman RS, Thornton GM, Lo IK. Knotless anchors with sutures external to the anchor body may be at risk for suture cutting through osteopenic bone. Bone Joint Res. 2016 Jun;5(6):269-75. doi: 10.1302/2046-3758.56.2000535.

Reference Type BACKGROUND
PMID: 27357383 (View on PubMed)

Lee S, Hwang JT, Lee SS, Lee JH, Kim TY. Greater Tuberosity Bone Mineral Density and Rotator Cuff Tear Size Are Independent Factors Associated With Cutting-Through in Arthroscopic Suture-Bridge Rotator Cuff Repair. Arthroscopy. 2021 Jul;37(7):2077-2086. doi: 10.1016/j.arthro.2021.01.059. Epub 2021 Feb 10.

Reference Type DERIVED
PMID: 33581302 (View on PubMed)

Other Identifiers

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2014-33

Identifier Type: -

Identifier Source: org_study_id

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