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The Effect of Microfracture Procedure on Rotator Cuff Tendon Healing

NCT ID: NCT04421417

Last Updated: 2021-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-15

Study Completion Date

2022-09-15

Brief Summary

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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.

Detailed Description

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Conditions

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Rotator Cuff Tears Micro Fracture

Keywords

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Superb microvascular imaging Rotator Cuff Tears Micro Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Standard Arthroscopic Rotator Cuff Repair

Group Type ACTIVE_COMPARATOR

Standard Arthroscopic Rotator Cuff Repair

Intervention Type PROCEDURE

Standard Arthroscopic Rotator Cuff Repair

Microfracture and Arthroscopic Rotator Cuff Repair

Group Type EXPERIMENTAL

Microfracture + Standard Arthroscopic Rotator Cuff Repair

Intervention Type PROCEDURE

drilling of rotator cuff footprint area on humerus and standard arthroscopic rotator cuff repair

Interventions

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Microfracture + Standard Arthroscopic Rotator Cuff Repair

drilling of rotator cuff footprint area on humerus and standard arthroscopic rotator cuff repair

Intervention Type PROCEDURE

Standard Arthroscopic Rotator Cuff Repair

Standard Arthroscopic Rotator Cuff Repair

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* degenerative rotator cuff tears

Exclusion Criteria

* traumatic rotator cuff tears
* rheumatoid diseases
* previous surgery of rotator cuff tendon
* glenohumeral arthritis
* acromioclavicular arthritis
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Göker Utku değer

OTHER

Sponsor Role lead

Responsible Party

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Göker Utku değer

Research assistant

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Istanbul University- Cerrahpasa Cerrahpasa Medical Faculty

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 22495146 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24331121 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23522987 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23760681 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28395947 (View on PubMed)

Other Identifiers

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2019-78167

Identifier Type: -

Identifier Source: org_study_id