Clinical trial NCT04587180: Cutting-through at the Greater Tuberosity
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotator Cuff Tears
Keywords: rotator cuff tear
cutting-through
Bone mineral density
suture-bridge repair
Lead sponsor: Chuncheon Sacred Heart Hospital
Sponsor class: OTHER
Collaborators: name: Hallym University
First posted: 2020-10-14
Enrollment: 95
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with arthroscopic rotator cuff suture-bridge repair for full-thickness rotator cuff tears

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The occurrence of cutting-through
timeFrame: During the surgery
measure: Visual Analog Scale (VAS) Pain Score
timeFrame: 2 years after surgery
measure: American Shoulder and Elbow Surgeons (ASES) score
timeFrame: 2 years after surgery
measure: Greater tuberosity bone mineral density
timeFrame: preoperatively
measure: Lumbar spine bone mineral density
timeFrame: preoperatively
measure: Hip bone mineral density
timeFrame: preoperatively
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Chuncheon Sacred Heart Hospital
name: Jung-Taek Hwang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.
citation: 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.