Cutting-through at the Greater Tuberosity

Rotator Cuff Tears Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04587180
• Other study ID #: 2014-33
• Status: Completed
• Start date: June 1, 2014
• Est. completion date: December 31, 2015

Study information

• Verified date: October 2020
• Source: Chuncheon Sacred Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: December 31, 2015
• Est. primary completion date: October 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tears

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Chuncheon Sacred Heart Hospital	Hallym University

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The occurrence of cutting-through	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
Primary	Visual Analog Scale (VAS) Pain Score	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
Primary	American Shoulder and Elbow Surgeons (ASES) score	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
Primary	Greater tuberosity bone mineral density	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
Primary	Lumbar spine bone mineral density	Measured by using standard techniques according to the manufacturer and the International Society for Clinical Densitometry guidelines.	preoperatively
Primary	Hip bone mineral density	Measured by using standard techniques according to the manufacturer and the International Society for Clinical Densitometry guidelines.	preoperatively