Microfracture at Proximal Humerus Lateral to Footprint Could Enhance the Rotator Cuff Healing
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lateralised microfracture.
- Who it may be relevant to
- Registry conditions: Rotator Cuff Tears, Micro Fracture. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Randomized Controlled Trial of Patients Treated With and Without Lateralized Microfracture During Rotator Cuff Repair
Overview
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: * \[whether the lateralized microfracture could decrease the retear rate after arthroscopy rotator cuff repair.\] * \[whether the lateralized microfracture could improve the functional recovery after arthroscopy rotator cuff repair.\] 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.
Interventions
- Procedure Lateralised microfracture
making microfracture(4 holes with 2mm diameter) at the lateral side of the footprint right after arthroscopy rotator repair.
Primary outcome measures
- Magnetic Resonance Imaging (MRI) [Time frame: 24 months postoperative]
Secondary outcome measures (5)
- Active range of motion of Shoulder [Time frame: Preoperative, 3 months and 24 months postoperative]
- Passive range of motion of Shoulder [Time frame: Preoperative, 3 months and 24 months postoperative]
- American Shoulder and Elbow Score [Time frame: Preoperative, 3 months and 24 months postoperative]
- University at California at Los Angeles Shouder Rating Scale [Time frame: Preoperative, 3 months and 24 months postoperative]
- Visual Analog Scale for Pain [Time frame: Preoperative, 3 months and 24 months postoperative]
Eligibility criteria
Inclusion criteria
- Medium to large Rotator cuff tear(1cm-5cm) diagnosed by MRI
- Patients can complete the follow-up and comply with all post-operative rehab instructions
- Failure of non-operative treatment for at least 3 months
Exclusion criteria
- Revision rotator cuff surgery
- Partial thickness rotator cuff tears
- Small (less than 1cm) and Massive (greater than 5cm) rotator cuff tears
- Disease history of the affected shoulder
- Systemic immune diseases
- Irreparable rotator cuff tear
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Affiliated Hospital of Nantong University — Nantong
- Afiliated Hospital of Nantong University — Nantong
Publications
- 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. PMID 23942284
- 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. PMID 26546301
- 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. PMID 30266548
- 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. PMID 31928410
- 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. PMID 12724676
- 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. PMID 23760681
- 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. PMID 22543003
Identifiers
NCT: NCT05624164 · micorfracture