The Effect of Microfracture Procedure on Rotator Cuff Tendon Healing

NCT04421417 | Suspended

• 1 other identifier: 2019-78167
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tears; Micro Fracture

Keywords

Superb microvascular imaging; Rotator Cuff Tears; Micro Fracture

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• functional outcome

  24th week

Study Arms (2)

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

Interventions

Microfracture + Standard Arthroscopic Rotator Cuff Repair PROCEDURE

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

Microfracture and Arthroscopic Rotator Cuff Repair

Standard Arthroscopic Rotator Cuff Repair PROCEDURE

Standard Arthroscopic Rotator Cuff Repair

Standard Arthroscopic Rotator Cuff Repair

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• degenerative rotator cuff tears

You may not qualify if:

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

Sponsors & Collaborators

• Göker Utku değer: lead

Study Sites (1)

Istanbul University- Cerrahpasa Cerrahpasa Medical Faculty

Istanbul, 34098, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 22495146 BACKGROUND

• 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.

  PMID: 24331121 BACKGROUND

• 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.

  PMID: 23522987 BACKGROUND

• 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.

  PMID: 23760681 BACKGROUND

• 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.

  PMID: 28395947 BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries; Fractures, Stress

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Fractures, Bone

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research assistant

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 9, 2020
• Study Start: September 15, 2020
• Primary Completion: September 15, 2021
• Study Completion: September 15, 2022
• Last Updated: November 19, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)