Microfracture at Proximal Humerus Lateral to Footprint Could Enhance the Rotator Cuff Healing
NCT ID: NCT05624164
Last Updated: 2022-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
88 participants
INTERVENTIONAL
2022-10-01
2026-12-31
Brief Summary
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* \[whether the lateralized microfracture could decrease the retear rate after arthroscopy rotator cuff repair.\]
* \[whether the lateralized microfracture could improve the functional recovery after arthroscopy rotator cuff repair.\] Participants with medium to larger size rotator cuff tears will be randomly assigned to the study group treated with lateralized microfracture immediately after arthroscopy rotator cuff repair or the control group treated with conventional arthroscopy rotator cuff repair without microfracture.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Lateralized microfracture group
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.
Lateralised microfracture
making microfracture(4 holes with 2mm diameter) at the lateral side of the footprint right after arthroscopy rotator repair.
No microfracture group
Participants with medium to larger size rotator cuff tears will be treated with arthroscopy rotator cuff repair without microfracture.
No interventions assigned to this group
Interventions
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Lateralised microfracture
making microfracture(4 holes with 2mm diameter) at the lateral side of the footprint right after arthroscopy rotator repair.
Eligibility Criteria
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Inclusion Criteria
2. Patients can complete the follow-up and comply with all post-operative rehab instructions
3. Failure of non-operative treatment for at least 3 months
Exclusion Criteria
2. Partial thickness rotator cuff tears
3. Small (less than 1cm) and Massive (greater than 5cm) rotator cuff tears
4. Disease history of the affected shoulder
5. Systemic immune diseases
6. Irreparable rotator cuff tear
18 Years
65 Years
ALL
No
Sponsors
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Affiliated Hospital of Nantong University
OTHER
Responsible Party
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Principal Investigators
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Yucheng Sun, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Affiliated Hospital of Nantong University
Locations
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Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
Afiliated Hospital of Nantong University
Nantong, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Mingbing Xiao, MD
Role: primary
References
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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.
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.
Other Identifiers
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micorfracture
Identifier Type: -
Identifier Source: org_study_id
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