NCT04587180

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2015

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

1.4 years

First QC Date

October 7, 2020

Last Update Submit

October 13, 2020

Conditions

Rotator Cuff Tears

Keywords

rotator cuff tearcutting-throughBone mineral densitysuture-bridge repair

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • Lumbar spine bone mineral density

    Measured by using standard techniques according to the manufacturer and the International Society for Clinical Densitometry guidelines.

    preoperatively

  • Hip bone mineral density

    Measured by using standard techniques according to the manufacturer and the International Society for Clinical Densitometry guidelines.

    preoperatively

Study Arms (2)

Patients with cutting-through

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

Procedure: Arthroscopic suture-bridge rotator cuff repair

Patients without cutting-through

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

Procedure: Arthroscopic suture-bridge rotator cuff repair

Interventions

Arthroscopic suture-bridge rotator cuff repairPROCEDURE

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 with cutting-throughPatients without cutting-through

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with arthroscopic rotator cuff suture-bridge repair for full-thickness rotator cuff tears

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 24388151BACKGROUND

  • 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.

    PMID: 25027108BACKGROUND

  • 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.

    PMID: 31805019BACKGROUND

  • 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.

    PMID: 27357383BACKGROUND

  • 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.

    PMID: 33581302DERIVED

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Study Officials

  • Jung-Taek Hwang, MD, PhD

    Chuncheon Sacred Heart Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 7, 2020

First Posted

October 14, 2020

Study Start

June 1, 2014

Primary Completion

October 31, 2015

Study Completion

December 31, 2015

Last Updated

October 19, 2020

Record last verified: 2020-10