Skip to content

The Effect of Microfracture Procedure on Rotator Cuff Tendon Healing

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

Status
Suspended
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04421417
Enrollment
30
Registered
2020-06-09
Start date
2020-09-15
Completion date
2022-09-15
Last updated
2021-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Micro Fracture, Rotator Cuff Tears

Keywords

Superb microvascular imaging, Rotator Cuff Tears, Micro Fracture

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.

Interventions

PROCEDUREMicrofracture + Standard Arthroscopic Rotator Cuff Repair

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

Standard Arthroscopic Rotator Cuff Repair

Sponsors

Göker Utku değer
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* degenerative rotator cuff tears

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
assessing early change of tendon and footprint area vascularity4th weekwe will evaluate it by superb microvascular imaging via ultrasound, this ultrasound software give us quantitative value of vascularity

Secondary

MeasureTime frameDescription
functional outcome24th weekThis 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).

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026