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Rotator Cuff TearsNCT05624164

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

A study testing Lateralised microfracture in people with Rotator Cuff Tears and Micro Fracture, run by Affiliated Hospital of Nantong University at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Rotator Cuff Tears, Micro Fracture
What is being tested?
Lateralised microfracture
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
2 sitesChina
Study dates
1 Oct 2022to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Mingbing Xiao, Ph.D contact

+86051381162222

tdfykjc@163.com

China2 sites, 2 recruiting

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu, 226001

    Mingbing Xiao, Ph.D, +86051381162222, tdfykjc@163.com

    Not yet recruiting

  • Afiliated Hospital of Nantong University

    Nantong, Jiangsu, 226001

    Mingbing Xiao, MD, +86051385052222

    Recruiting

Other trials in China

About this study

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

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.
Being tested
Lateralised microfracture
Keywords
rotator cuff tear, microfracture
Medical subject headings
Rotator Cuff Injuries, Fractures, Stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lateralised microfractureProcedure or surgery

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

Study groups in NCT05624164
Study groupRoleWhat they receive
Lateralized microfracture groupExperimentalParticipants 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.
Receives: Procedure: Lateralised microfracture
No microfracture groupNo interventionParticipants with medium to larger size rotator cuff tears will be treated with arthroscopy rotator cuff repair without microfracture.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 24 months postoperative

Secondary outcomes (5)

  1. 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.

    Measured: Preoperative, 3 months and 24 months postoperative

  2. 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.

    Measured: Preoperative, 3 months and 24 months postoperative

  3. 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.

    Measured: Preoperative, 3 months and 24 months postoperative

  4. 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.

    Measured: Preoperative, 3 months and 24 months postoperative

  5. 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.

    Measured: Preoperative, 3 months and 24 months postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2022
  2. Study start1 Oct 2022
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05624164
Sponsor's protocol ID
micorfracture
Status last verified
Aug 2022
First submitted
30 Oct 2022
Last updated
22 Nov 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 22543003

Questions about this trial

What is this clinical trial studying?

A study testing Lateralised microfracture in people with Rotator Cuff Tears and Micro Fracture, run by Affiliated Hospital of Nantong University at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mingbing Xiao, Ph.D (+86051381162222, tdfykjc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Magnetic Resonance Imaging (MRI) (time frame: 24 months postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05624164, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2022.

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