large and massive tearing of rotator cuff repair with and without ultra-pro mesh augmentation

The outcome of large and massive tearing of rotator cuff repair with and without ultra-pro mesh augmentation

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210806052092N1

Enrollment

126

Registered

2021-11-01

Start date

2021-09-17

Completion date

Unknown

Last updated

2021-11-29

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

Conditions

The outcome of large and massive tearing of rotator cuff repair with and without ultra-pro mesh augmentation. Rotator cuff tear or rupture, not specified as traumatic

Interventions

Intervention 1: Control group: Control group: Patients with rotator cuff rupture who have been nominated for surgery using examination and MRI, have inclusion criteria and consent to participate in th

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Age between 18 to 75 The ability to read and write in Persian Rotator cuff tears greater than 3 cm that are candidates for open surgery The patients with the ability to exercise after surgery Signing the informed consent form

Exclusion criteria

Exclusion criteria: Patients with Irreparable rotator cuff rupture Rotator cuff tears that are smaller than 3 cm Patients with active inflammation or autoimmune disorders Patients with active infection or malignant disorder

Design outcomes

Primary

Measure	Time frame
BMI. Timepoint: At the beginning of the study. Method of measurement: Using the BMI calculation formula.;Tearing expansion. Timepoint: At the beginning of the study. Method of measurement: MRI.;Range of motion. Timepoint: At the beginning of the study. Method of measurement: Examination by a physician by filling in the available schematic forms attached to the proposal.;Pain. Timepoint: At the beginning of the study. Method of measurement: VAS( Visual Analogue Scale).	—

Measure

Time frame

BMI. Timepoint: At the beginning of the study. Method of measurement: Using the BMI calculation formula.;Tearing expansion. Timepoint: At the beginning of the study. Method of measurement: MRI.;Range of motion. Timepoint: At the beginning of the study. Method of measurement: Examination by a physician by filling in the available schematic forms attached to the proposal.;Pain. Timepoint: At the beginning of the study. Method of measurement: VAS( Visual Analogue Scale).

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Secondary

Measure	Time frame
Pain. Timepoint: 48 hours after surgery and at the end of the first and third months. Method of measurement: VAS (Visual Analogue Scale).;Shoulder'sRange of motion. Timepoint: The first month, the third month and six months after surgery. Method of measurement: Examination by a physician by filling in the available schematic forms attached to the proposal.;Cuff muscle strength. Timepoint: The first month, the third month and six months after surgery. Method of measurement: Clinical Examination.;Repair or re-rupture. Timepoint: The first month, the third month and six months after surgery. Method of measurement: MRI.	—

Measure

Time frame

Pain. Timepoint: 48 hours after surgery and at the end of the first and third months. Method of measurement: VAS (Visual Analogue Scale).;Shoulder'sRange of motion. Timepoint: The first month, the third month and six months after surgery. Method of measurement: Examination by a physician by filling in the available schematic forms attached to the proposal.;Cuff muscle strength. Timepoint: The first month, the third month and six months after surgery. Method of measurement: Clinical Examination.;Repair or re-rupture. Timepoint: The first month, the third month and six months after surgery. Method of measurement: MRI.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmir Heidari

Tehran University of Medical Sciences

amirheydari????@gmail.com+98 21 8490 2388

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026