Microfracture at Proximal Humerus Lateral to Footprint Could Enhance the Rotator Cuff Healing

Rotator Cuff Tears Clinical Trial

Official title:

Randomized Controlled Trial of Patients Treated With and Without Lateralized Microfracture During Rotator Cuff Repair

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05624164
• Other study ID #: micorfracture
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: August 2022
• Source: Affiliated Hospital of Nantong University
• Contact: Mingbing Xiao, Ph.D
• Phone: +86051381162222
• Email: tdfykjc[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Stress
• Micro Fracture
• Rotator Cuff Injuries
• Rotator Cuff Tears

Intervention

Procedure:
• Lateralised microfracture
making microfracture(4 holes with 2mm diameter) at the lateral side of the footprint right after arthroscopy rotator repair.

Locations

Country	Name	City	State
China	Affiliated Hospital of Nantong University	Nantong	Jiangsu
China	Afiliated Hospital of Nantong University	Nantong	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital of Nantong University

Country where clinical trial is conducted

China, 

References & Publications (7)

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 — View 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. — View 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 — View 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 — View 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. — View 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. Review. — View 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: 10.1177/0363546519896 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Active range of motion of Shoulder	Active forward flexion, abduction and external rotation will be measured with a manual goniometer at the preoperative visit, 3 months and 24 months after surgery.	Preoperative, 3 months and 24 months postoperative
Secondary	Passive range of motion of Shoulder	Passive forward flexion, abduction and external rotation will be measured with a manual goniometer at the preoperative visit, 3 months and 24 months after surgery.	Preoperative, 3 months and 24 months postoperative
Secondary	American Shoulder and Elbow Score	American Shoulder and Elbow scores (minimum 0 points, maximum 100 points, higher values are considered better outcomes) of patients with rotator cuff tears treated with and without lateralized microfracture at the preoperative visit, 3 months and 24 months after surgery.	Preoperative, 3 months and 24 months postoperative
Secondary	University at California at Los Angeles Shouder Rating Scale	University at California at Los Angeles Shoulder Rating Scale(minimum 3 points, maximum 35 points, higher values are considered better outcomes) of patients with rotator cuff tears treated with and without lateralized microfracture at the preoperative visit, 3 months and 24 months after surgery.	Preoperative, 3 months and 24 months postoperative
Secondary	Visual Analog Scale for Pain	Visual Analog Scale for Pain(minimum 0 points, maximum 10 points, higher values are considered worse outcomes) of patients with rotator cuff tears treated with and without lateralized microfracture at the preoperative visit, 3 months, and 24 months after surgery.	Preoperative, 3 months and 24 months postoperative