The Effect of Microfracture Procedure on Rotator Cuff Tendon Healing

Not Applicable

Suspended

• Conditions: Micro Fracture; Rotator Cuff Tears
• Interventions: Procedure: Standard Arthroscopic Rotator Cuff Repair; Procedure: Microfracture + Standard Arthroscopic Rotator Cuff Repair

• Registration Number: NCT04421417
• Lead Sponsor: Göker Utku değer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-02
• Study First Submitted QC: 2020-06-04
• Study First Posted: 2020-06-09
• Study Start: 2020-09-15
• Primary Completion: 2021-09-15
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-16
• Last Update Posted: 2021-11-19
• Study Completion: 2022-09-15

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• degenerative rotator cuff tears

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Arthroscopic Rotator Cuff Repair	Standard Arthroscopic Rotator Cuff Repair	-
Microfracture and Arthroscopic Rotator Cuff Repair	Microfracture + Standard Arthroscopic Rotator Cuff Repair	-

Primary Outcome Measures

Name	Time	Method
assessing early change of tendon and footprint area vascularity	12th week	we will evaluate it by superb microvascular imaging via ultrasound, this ultrasound software give us quantitative value of vascularity

Secondary Outcome Measures

Name	Time	Method
functional outcome	24th week	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).

Trial Locations

Locations (1)

Istanbul University- Cerrahpasa Cerrahpasa Medical Faculty; 🇹🇷 Istanbul, Turkey