Clinical trial NCT05624164: Microfracture at Proximal Humerus Lateral to Footprint Could Enhance the Rotator Cuff Healing
Official title: Randomized Controlled Trial of Patients Treated With and Without Lateralized Microfracture During Rotator Cuff Repair
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rotator Cuff Tears
Micro Fracture
Keywords: rotator cuff tear
microfracture
Lead sponsor: Affiliated Hospital of Nantong University
Sponsor class: OTHER
First posted: 2022-11-22
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Medium to large Rotator cuff tear(1cm-5cm) diagnosed by MRI
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:

1. Revision rotator cuff surgery
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

Primary outcomes:
measure: Magnetic Resonance Imaging (MRI)
timeFrame: 24 months postoperative
Secondary outcomes:
measure: Active range of motion of Shoulder
timeFrame: Preoperative, 3 months and 24 months postoperative
measure: Passive range of motion of Shoulder
timeFrame: Preoperative, 3 months and 24 months postoperative
measure: American Shoulder and Elbow Score
timeFrame: Preoperative, 3 months and 24 months postoperative
measure: University at California at Los Angeles Shouder Rating Scale
timeFrame: Preoperative, 3 months and 24 months postoperative
measure: Visual Analog Scale for Pain
timeFrame: Preoperative, 3 months and 24 months postoperative
Other outcomes:
Locations:
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangsu
city: Nantong
country: China
facility: Afiliated Hospital of Nantong University
state: Jiangsu
Study officials:
affiliation: Affiliated Hospital of Nantong University
name: Yucheng Sun, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.