Back to resultsThe Effect of Microfracture Procedure on Rotator Cuff Tendon Healing
Primary Purpose
Rotator Cuff Tears, Micro Fracture
Status
Suspended
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Microfracture + Standard Arthroscopic Rotator Cuff Repair
Standard Arthroscopic Rotator Cuff Repair
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Tears focused on measuring Superb microvascular imaging, Rotator Cuff Tears, Micro Fracture
Eligibility Criteria
Inclusion Criteria:
- degenerative rotator cuff tears
Exclusion Criteria:
- traumatic rotator cuff tears
- rheumatoid diseases
- previous surgery of rotator cuff tendon
- glenohumeral arthritis
- acromioclavicular arthritis
Sites / Locations
- Istanbul University- Cerrahpasa Cerrahpasa Medical Faculty
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard Arthroscopic Rotator Cuff Repair
Microfracture and Arthroscopic Rotator Cuff Repair
Arm Description
Outcomes
Primary Outcome Measures
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
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
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
Secondary Outcome Measures
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04421417
Brief Title
The Effect of Microfracture Procedure on Rotator Cuff Tendon Healing
Official Title
Early-term Effects of Microfracture on Tendon Vascularity and Healing in Arthroscopic Treatment of Chronic Rotator Cuff Tears: A Prospective Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Suspended
Why Stopped
Study was stopped due to COVID-19 related issues. Collected data could be present as pilot trial.
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
September 15, 2021 (Actual)
Study Completion Date
September 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Göker Utku değer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tears, Micro Fracture
Keywords
Superb microvascular imaging, Rotator Cuff Tears, Micro Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard Arthroscopic Rotator Cuff Repair
Arm Type
Active Comparator
Arm Title
Microfracture and Arthroscopic Rotator Cuff Repair
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Microfracture + Standard Arthroscopic Rotator Cuff Repair
Intervention Description
drilling of rotator cuff footprint area on humerus and standard arthroscopic rotator cuff repair
Intervention Type
Procedure
Intervention Name(s)
Standard Arthroscopic Rotator Cuff Repair
Intervention Description
Standard Arthroscopic Rotator Cuff Repair
Primary Outcome Measure Information:
Title
assessing early change of tendon and footprint area vascularity
Description
we will evaluate it by superb microvascular imaging via ultrasound, this ultrasound software give us quantitative value of vascularity
Time Frame
4th week
Title
assessing early change of tendon and footprint area vascularity
Description
we will evaluate it by superb microvascular imaging via ultrasound, this ultrasound software give us quantitative value of vascularity
Time Frame
8th week
Title
assessing early change of tendon and footprint area vascularity
Description
we will evaluate it by superb microvascular imaging via ultrasound, this ultrasound software give us quantitative value of vascularity
Time Frame
12th week
Secondary Outcome Measure Information:
Title
functional outcome
Description
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).
Time Frame
24th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
degenerative rotator cuff tears
Exclusion Criteria:
traumatic rotator cuff tears
rheumatoid diseases
previous surgery of rotator cuff tendon
glenohumeral arthritis
acromioclavicular arthritis
Facility Information:
Facility Name
Istanbul University- Cerrahpasa Cerrahpasa Medical Faculty
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22495146
Citation
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.
Results Reference
background
PubMed Identifier
24331121
Citation
Zumstein 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.
Results Reference
background
PubMed Identifier
23522987
Citation
Milano 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.
Results Reference
background
PubMed Identifier
23760681
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.
Results Reference
background
PubMed Identifier
28395947
Citation
Bilsel 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.
Results Reference
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The Effect of Microfracture Procedure on Rotator Cuff Tendon Healing
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