- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04587180
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
Intervention / Treatment
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:
- 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
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.
Sponsor
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.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-33
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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