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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for not_applicable

Timeline

8mo left

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach

1 country

2 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.3 years study duration

Study Progress85%

Oct 2022Dec 2026

Study Start

First participant enrolled

October 1, 2022

Completed

29 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2022

Completed

23 days until next milestone

First Posted

Study publicly available on registry

November 22, 2022

Completed

3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected

Last Updated

November 22, 2022

Status Verified

August 1, 2022

Enrollment Period

3.3 years

First QC Date

October 30, 2022

Last Update Submit

November 17, 2022

Conditions

Rotator Cuff Tears Micro Fracture

Keywords

rotator cuff tearmicrofracture

Outcome Measures

Primary Outcomes (1)

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 Outcomes (5)

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

Study Arms (2)

Lateralized microfracture group

EXPERIMENTAL

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.

Procedure: Lateralised microfracture

No microfracture group

NO INTERVENTION

Participants with medium to larger size rotator cuff tears will be treated with arthroscopy rotator cuff repair without microfracture.

Interventions

Lateralised microfracturePROCEDURE

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

Lateralized microfracture group

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Affiliated Hospital of Nantong Universitylead

Study Sites (2)

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226001, China

NOT YET RECRUITING

Afiliated Hospital of Nantong University

Nantong, Jiangsu, 226001, China

RECRUITING

Related Publications (7)

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: 23942284RESULT
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: 26546301RESULT
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: 30266548RESULT
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: 31928410RESULT
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: 12724676RESULT
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: 23760681RESULT
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: 22543003RESULT

MeSH Terms

Conditions

Rotator Cuff InjuriesFractures, Stress

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon InjuriesFractures, Bone

Study Officials

Yucheng Sun, Ph.D
Affiliated Hospital of Nantong University
PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingbing Xiao, Ph.D

CONTACT

+86051381162222 tdfykjc@163.com

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 30, 2022

First Posted

November 22, 2022

Study Start

October 1, 2022

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

November 22, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing: Will not share

Locations

CN(2)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

Lateralized microfracture group

No microfracture group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Publications (7)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations