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The Effect of Microfracture Procedure on Rotator Cuff Tendon Healing

G

Göker Utku değer

Status

Suspended

Conditions

Micro Fracture
Rotator Cuff Tears

Treatments

Procedure: Standard Arthroscopic Rotator Cuff Repair
Procedure: Microfracture + Standard Arthroscopic Rotator Cuff Repair

Study type

Interventional

Funder types

Other

Identifiers

NCT04421417
2019-78167

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

40 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • degenerative rotator cuff tears

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

30 participants in 2 patient groups

Standard Arthroscopic Rotator Cuff Repair
Active Comparator group
Treatment:
Procedure: Standard Arthroscopic Rotator Cuff Repair
Microfracture and Arthroscopic Rotator Cuff Repair
Experimental group
Treatment:
Procedure: Microfracture + Standard Arthroscopic Rotator Cuff Repair

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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