Microfracture at Proximal Humerus Lateral to Footprint Could Enhance the Rotator Cuff Healing
Randomized Controlled Trial of Patients Treated With and Without Lateralized Microfracture During Rotator Cuff Repair
Sponsor study identifier
interventional
88
1 country
2
Study Start
October 1, 2022
Actual (reported)Primary Completion
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The goal of this clinical trial is to test whether there is any effect on rotator cuff healing by making microfracture at the lateral side of the footprint. The main question it aims to answer are:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 1, 2022
Actual (reported)October 30, 2022
Actual (reported)November 22, 2022
Actual (reported)December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Magnetic Resonance Imaging (MRI)
The scans were evaluated for rotator cuff integrity and degree of re-tears (no re-tears, partial or complete re-tear) by an independent radiologist
24 months postoperative
Active range of motion of Shoulder
Preoperative, 3 months and 24 months postoperative
Passive range of motion of Shoulder
Preoperative, 3 months and 24 months postoperative
American Shoulder and Elbow Score
Preoperative, 3 months and 24 months postoperative
University at California at Los Angeles Shouder Rating Scale
Preoperative, 3 months and 24 months postoperative
Visual Analog Scale for Pain
Preoperative, 3 months and 24 months postoperative
Participants with medium to larger size rotator cuff tears will be treated with arthroscopy rotator cuff repair with microfracture at the lateral side of the footprint immediately.
Participants with medium to larger size rotator cuff tears will be treated with arthroscopy rotator cuff repair without microfracture.
making microfracture(4 holes with 2mm diameter) at the lateral side of the footprint right after arthroscopy rotator repair.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226001, China
Afiliated Hospital of Nantong University
Nantong, Jiangsu, 226001, China
Jo CH, Shin JS, Park IW, Kim H, Lee SY. Multiple channeling improves the structural integrity of rotator cuff repair. Am J Sports Med. 2013 Nov;41(11):2650-7. doi: 10.1177/0363546513499138. Epub 2013 Aug 13.
Orth P, Duffner J, Zurakowski D, Cucchiarini M, Madry H. Small-Diameter Awls Improve Articular Cartilage Repair After Microfracture Treatment in a Translational Animal Model. Am J Sports Med. 2016 Jan;44(1):209-19. doi: 10.1177/0363546515610507. Epub 2015 Nov 6.
Yucheng Sun, Ph.D
Affiliated Hospital of Nantong University
First Submitted
October 30, 2022
First Posted
November 22, 2022
Study Start
October 1, 2022
Actual (reported)Primary Completion
December 31, 2025
Estimated (date passed)Study on the Application of Shock Wave Technique After Rotator Cuff Operation
Contact the study team to confirm eligibility.
de Girolamo L, Jannelli E, Fioruzzi A, Fontana A. Acetabular Chondral Lesions Associated With Femoroacetabular Impingement Treated by Autologous Matrix-Induced Chondrogenesis or Microfracture: A Comparative Study at 8-Year Follow-Up. Arthroscopy. 2018 Nov;34(11):3012-3023. doi: 10.1016/j.arthro.2018.05.035. Epub 2018 Sep 25.
Sun Y, Kwak JM, Kholinne E, Zhou Y, Tan J, Koh KH, Jeon IH. Small Subchondral Drill Holes Improve Marrow Stimulation of Rotator Cuff Repair in a Rabbit Model of Chronic Rotator Cuff Tear. Am J Sports Med. 2020 Mar;48(3):706-714. doi: 10.1177/0363546519896350. Epub 2020 Jan 13.
Steadman JR, Briggs KK, Rodrigo JJ, Kocher MS, Gill TJ, Rodkey WG. Outcomes of microfracture for traumatic chondral defects of the knee: average 11-year follow-up. Arthroscopy. 2003 May-Jun;19(5):477-84. doi: 10.1053/jars.2003.50112.
Osti L, Del Buono A, Maffulli N. Microfractures at the rotator cuff footprint: a randomised controlled study. Int Orthop. 2013 Nov;37(11):2165-71. doi: 10.1007/s00264-013-1952-z. Epub 2013 Jun 13.
Kida Y, Morihara T, Matsuda K, Kajikawa Y, Tachiiri H, Iwata Y, Sawamura K, Yoshida A, Oshima Y, Ikeda T, Fujiwara H, Kawata M, Kubo T. Bone marrow-derived cells from the footprint infiltrate into the repaired rotator cuff. J Shoulder Elbow Surg. 2013 Feb;22(2):197-205. doi: 10.1016/j.jse.2012.02.007. Epub 2012 Apr 28.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
November 22, 2022
Record last verified: 2022-08
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Source: ClinicalTrials.gov.
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