The Effect of Microfracture Procedure on Rotator Cuff Tendon Healing

Rotator Cuff Tears Clinical Trial

Official title:

Early-term Effects of Microfracture on Tendon Vascularity and Healing in Arthroscopic Treatment of Chronic Rotator Cuff Tears: A Prospective Randomized Trial

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04421417
• Other study ID #: 2019-78167
• Status: Suspended
• Phase: N/A
• Start date: September 15, 2020
• Est. completion date: September 15, 2022

Study information

• Verified date: November 2021
• Source: Istanbul University-Cerrahpasa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 30
• Est. completion date: September 15, 2022
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

• degenerative rotator cuff tears

Exclusion Criteria:

• traumatic rotator cuff tears
• rheumatoid diseases
• previous surgery of rotator cuff tendon
• glenohumeral arthritis
• acromioclavicular arthritis

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Microfracture + Standard Arthroscopic Rotator Cuff Repair
drilling of rotator cuff footprint area on humerus and standard arthroscopic rotator cuff repair
• Standard Arthroscopic Rotator Cuff Repair
Standard Arthroscopic Rotator Cuff Repair

Locations

Country	Name	City	State
Turkey	Istanbul University- Cerrahpasa Cerrahpasa Medical Faculty	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Göker Utku deger

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View 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. — 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

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4th week
Primary	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	8th week
Primary	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	12th week
Secondary	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).	24th week