Rotator Cuff TearsNCT04421417
The Effect of Microfracture Procedure on Rotator Cuff Tendon Healing
A study testing Microfracture + Standard Arthroscopic Rotator Cuff Repair and Standard Arthroscopic Rotator Cuff Repair in people with Rotator Cuff Tears and Micro Fracture, run by Göker Utku değer at 1 site in Turkey (Türkiye).
Trial summary
Patients with complaints of shoulder pain or limitation of motion and had rotator cuff rupture diagnosed with magnetic resonance imaging will be analyzed and the patients with surgical indication will be included in a randomized fashion. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Rotator Cuff Tears, Micro Fracture
- What is being tested?
- Microfracture + Standard Arthroscopic Rotator Cuff Repair and Standard Arthroscopic Rotator Cuff Repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2020to 15 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- degenerative rotator cuff tears
Who cannot join
- traumatic rotator cuff tears
- rheumatoid diseases
- previous surgery of rotator cuff tendon
- glenohumeral arthritis
- acromioclavicular arthritis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University- Cerrahpasa Cerrahpasa Medical Faculty
Istanbul, 34098
About this study
Official title: Early-term Effects of Microfracture on Tendon Vascularity and Healing in Arthroscopic Treatment of Chronic Rotator Cuff Tears: A Prospective Randomized Trial
Patients with complaints of shoulder pain or limitation of motion and had rotator cuff rupture diagnosed with magnetic resonance imaging will be analyzed and the patients with surgical indication will be included in a randomized fashion. One group of patient will undergo standard arthroscopic rotator cuff repair, while the other group will have microfracture procedure in addition to the standard arthroscopic repair. Before the operation, functional and clinical conditions will be recorded with Constant and American Shoulder and Elbow Surgeons Shoulder Score (ASES) universal shoulder scoring systems and Visual Analogue Scale(VAS) pain scale. The blood supply and healing of the tendon in the repair area will be compared by the doppler ultrasound (superb microvascular imaging) at the 2nd, 4th, 8th and 12th week after the operation. Post-operative clinical, functional status and pain levels will be evaluated with Constant, ASES and VAS pain scales at 24th week.
- Conditions
- Rotator Cuff Tears, Micro Fracture
- Being tested
- Microfracture + Standard Arthroscopic Rotator Cuff Repair, Standard Arthroscopic Rotator Cuff Repair
- Keywords
- Superb microvascular imaging, Rotator Cuff Tears, Micro Fracture
- 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.
Microfracture + Standard Arthroscopic Rotator Cuff RepairProcedure or surgery
drilling of rotator cuff footprint area on humerus and standard arthroscopic rotator cuff repair
Standard Arthroscopic Rotator Cuff RepairProcedure or surgery
Standard Arthroscopic Rotator Cuff Repair
| Study group | Role | What they receive |
|---|---|---|
| Standard Arthroscopic Rotator Cuff Repair | Active comparator | Not described Receives: Procedure: Standard Arthroscopic Rotator Cuff Repair |
| Microfracture and Arthroscopic Rotator Cuff Repair | Experimental | Not described Receives: Procedure: Microfracture + Standard Arthroscopic Rotator Cuff Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessing early change of tendon and footprint area vascularity
we will evaluate it by superb microvascular imaging via ultrasound, this ultrasound software give us quantitative value of vascularity
Measured: 4th week
assessing early change of tendon and footprint area vascularity
we will evaluate it by superb microvascular imaging via ultrasound, this ultrasound software give us quantitative value of vascularity
Measured: 8th week
assessing early change of tendon and footprint area vascularity
we will evaluate it by superb microvascular imaging via ultrasound, this ultrasound software give us quantitative value of vascularity
Measured: 12th week
Secondary outcomes (1)
functional outcome
This entity will be asses by functional scoring systems.These are American Shoulder and Elbow Surgeons Shoulder Score (ASES) and Constant Shoulder Score. The ASES is a composite instrument, requiring both a physician assessment and a patient-completed portion; however, it is commonly presented as solely the patient-reported survey. This includes a section on pain (7 items) and a section on activities of daily living (10 items). Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition. Constant Score was designed to assess the functional state of a normal, a diseased, or a treated shoulder.The Constant score contains both physician-completed and patient-reported portions. The four domains include pain (15 possible points), activities of daily living (20 possible points), mobility (40 possible points), and strength (25 possible points). Scores range from 0 points (most disability) to 100 points (least disability).
Measured: 24th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start15 Sep 2020
- Primary completion15 Sep 2021
- Study completion15 Sep 2022 (estimated)
Why it stopped: Study was stopped due to COVID-19 related issues. Collected data could be present as pilot trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Göker Utku değer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Göker Utku değer, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421417
- Sponsor's protocol ID
- 2019-78167
- Other IDs
- 2019
- Status last verified
- Nov 2021
- First submitted
- 2 Jun 2020
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rodeo SA, Delos D, Williams RJ, Adler RS, Pearle A, Warren RF. The effect of platelet-rich fibrin matrix on rotator cuff tendon healing: a prospective, randomized clinical study. Am J Sports Med. 2012 Jun;40(6):1234-41. doi: 10.1177/0363546512442924. Epub 2012 Apr 10.
PubMed 22495146Zumstein MA, Rumian A, Lesbats V, Schaer M, Boileau P. Increased vascularization during early healing after biologic augmentation in repair of chronic rotator cuff tears using autologous leukocyte- and platelet-rich fibrin (L-PRF): a prospective randomized controlled pilot trial. J Shoulder Elbow Surg. 2014 Jan;23(1):3-12. doi: 10.1016/j.jse.2013.08.017.
PubMed 24331121Milano G, Saccomanno MF, Careri S, Taccardo G, De Vitis R, Fabbriciani C. Efficacy of marrow-stimulating technique in arthroscopic rotator cuff repair: a prospective randomized study. Arthroscopy. 2013 May;29(5):802-10. doi: 10.1016/j.arthro.2013.01.019. Epub 2013 Mar 21.
PubMed 23522987Osti 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 23760681Bilsel K, Yildiz F, Kapicioglu M, Uzer G, Elmadag M, Pulatkan A, Esrefoglu M, Bozdag E, Milano G. Efficacy of bone marrow-stimulating technique in rotator cuff repair. J Shoulder Elbow Surg. 2017 Aug;26(8):1360-1366. doi: 10.1016/j.jse.2017.02.014. Epub 2017 Apr 7.
PubMed 28395947
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early-term Effects of Microfracture on Tendon Vascularity and Healing in Arthroscopic Treatment of Chronic Rotator Cuff Tears: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT04421417
- Acronym / sponsor ID
- 2019-78167
- Conditions
- Rotator Cuff Tears, Micro Fracture
- Keywords
- Superb microvascular imaging, Rotator Cuff Tears, Micro Fracture
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study was stopped due to COVID-19 related issues. Collected data could be present as pilot trial.
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Göker Utku değerUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 15 Sep 2022 (estimated)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with complaints of shoulder pain or limitation of motion and had rotator cuff rupture diagnosed with magnetic resonance imaging will be analyzed and the patients with surgical indication will be included in a randomized fashion. One group of patient will undergo standard arthroscopic rotator cuff repair, while the other group will have microfracture procedure in addition to the standard arthroscopic repair. Before the operation, functional and clinical conditions will be recorded with Constant and American Shoulder and Elbow Surgeons Shoulder Score (ASES) universal shoulder scoring systems and Visual Analogue Scale(VAS) pain scale. The blood supply and healing of the tendon in the repair area will be compared by the doppler ultrasound (superb microvascular imaging) at the 2nd, 4th, 8th and 12th week after the operation. Post-operative clinical, functional status and pain levels will be evaluated with Constant, ASES and VAS pain scales at 24th week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Arthroscopic Rotator Cuff Repair | Active comparator | Procedure: Standard Arthroscopic Rotator Cuff Repair |
| Microfracture and Arthroscopic Rotator Cuff Repair | Experimental | Procedure: Microfracture + Standard Arthroscopic Rotator Cuff Repair |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- degenerative rotator cuff tears
Key exclusion criteria (5 listed)
- traumatic rotator cuff tears
- rheumatoid diseases
- previous surgery of rotator cuff tendon
- glenohumeral arthritis
- acromioclavicular arthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microfracture + Standard Arthroscopic Rotator Cuff Repairdrilling of rotator cuff footprint area on humerus and standard arthroscopic rotator cuff repair | Procedure or surgery | Microfracture and Arthroscopic Rotator Cuff Repair |
| Standard Arthroscopic Rotator Cuff RepairStandard Arthroscopic Rotator Cuff Repair | Procedure or surgery | Standard Arthroscopic Rotator Cuff Repair |
Primary outcome
assessing early change of tendon and footprint area vascularity
Time frame: 4th week
we will evaluate it by superb microvascular imaging via ultrasound, this ultrasound software give us quantitative value of vascularity
assessing early change of tendon and footprint area vascularity
Time frame: 8th week
we will evaluate it by superb microvascular imaging via ultrasound, this ultrasound software give us quantitative value of vascularity
assessing early change of tendon and footprint area vascularity
Time frame: 12th week
we will evaluate it by superb microvascular imaging via ultrasound, this ultrasound software give us quantitative value of vascularity
1 secondary outcome
functional outcome
Time frame: 24th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
- Background: PubMed 22495146Rodeo SA, Delos D, Williams RJ, Adler RS, Pearle A, Warren RF. The effect of platelet-rich fibrin matrix on rotator cuff tendon healing: a prospective, randomized clinical study. Am J Sports Med. 2012 Jun;40(6):1234-41. doi: 10.1177/0363546512442924. Epub 2012 Apr 10.
- Background: PubMed 24331121Zumstein MA, Rumian A, Lesbats V, Schaer M, Boileau P. Increased vascularization during early healing after biologic augmentation in repair of chronic rotator cuff tears using autologous leukocyte- and platelet-rich fibrin (L-PRF): a prospective randomized controlled pilot trial. J Shoulder Elbow Surg. 2014 Jan;23(1):3-12. doi: 10.1016/j.jse.2013.08.017.
- Background: PubMed 23522987Milano G, Saccomanno MF, Careri S, Taccardo G, De Vitis R, Fabbriciani C. Efficacy of marrow-stimulating technique in arthroscopic rotator cuff repair: a prospective randomized study. Arthroscopy. 2013 May;29(5):802-10. doi: 10.1016/j.arthro.2013.01.019. Epub 2013 Mar 21.
- Background: PubMed 23760681Osti 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.
- Background: PubMed 28395947Bilsel K, Yildiz F, Kapicioglu M, Uzer G, Elmadag M, Pulatkan A, Esrefoglu M, Bozdag E, Milano G. Efficacy of bone marrow-stimulating technique in rotator cuff repair. J Shoulder Elbow Surg. 2017 Aug;26(8):1360-1366. doi: 10.1016/j.jse.2017.02.014. Epub 2017 Apr 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microfracture + Standard Arthroscopic Rotator Cuff Repair and Standard Arthroscopic Rotator Cuff Repair in people with Rotator Cuff Tears and Micro Fracture, run by Göker Utku değer at 1 site in Turkey (Türkiye).
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 1 inclusion and 5 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: paused, as of the sponsor's last update on 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessing early change of tendon and footprint area vascularity (time frame: 4th week). The study lists 3 primary outcomes in all. 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 NCT04421417, which also lists 5 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 19 Nov 2021.