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Evaluation of Tendon-to-Bone Healing Potential in Arthroscopic Rotator Cuff Repair Through Biological Stimulation

NCT ID: NCT03060928

Last Updated: 2017-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2020-12-31

Brief Summary

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Evaluation of clinical and radiological outcomes in patients undergoing Arthroscopic Rotator Cuff Repair with standard treatment compared to patients receiving biological stimulation with micro-perforations or with the combination of micro-perforations and use of Artelon® Tissue Reinforcement, a synthetic device based on degradable polyurethaneurea.

The investigators believe that this kind of tendon-to-bone healing stimulation with the two proposed methods can increase the repair quality by significantly decreasing the lesion recurrence rate (currently described for 15% of patients) and can improve various parameters such as pain, range of motion and strength, thereby hastening the return to daily activities and psycho-physical well-being.

Detailed Description

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Conditions

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Rotator Cuff Tear

Keywords

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Rotator Cuff Tear Artelon®

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Double Blind

Study Groups

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Control

Arthroscopic Rotator Cuff Repair with standard treatment

Group Type ACTIVE_COMPARATOR

Arthroscopic Rotator Cuff Repair

Intervention Type PROCEDURE

Arthroscopic Rotator Cuff Repair

Experimental 1

Arthroscopic Rotator Cuff Repair with standard treatment + biological stimulation with micro-perforations

Group Type EXPERIMENTAL

Arthroscopic Rotator Cuff Repair

Intervention Type PROCEDURE

Arthroscopic Rotator Cuff Repair

Micro-perforations

Intervention Type PROCEDURE

Biological stimulation with micro-perforations

Experimental 2

Arthroscopic Rotator Cuff Repair with standard treatment + biological stimulation with the combination of micro-perforations and use of Artelon® Tissue Reinforcement

Group Type EXPERIMENTAL

Arthroscopic Rotator Cuff Repair

Intervention Type PROCEDURE

Arthroscopic Rotator Cuff Repair

Micro-perforations

Intervention Type PROCEDURE

Biological stimulation with micro-perforations

Artelon®

Intervention Type PROCEDURE

Biological stimulation with Artelon® Tissue Reinforcement

Interventions

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Arthroscopic Rotator Cuff Repair

Arthroscopic Rotator Cuff Repair

Intervention Type PROCEDURE

Micro-perforations

Biological stimulation with micro-perforations

Intervention Type PROCEDURE

Artelon®

Biological stimulation with Artelon® Tissue Reinforcement

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* a medium rotator cuff tear (from 1 to 3 cm, according to Cofield Classification) with an indication for arthroscopic repair
* signed informed consensus

Exclusion Criteria

* previous fractures
* diabetes
* subscapularis tears
* tears \< 1cm or \> 3 cm
* reduced passive range of motion
* infections
* known mental or neurological disorders unwilling or unable to follow the post-surgery instructions
* conditions that contraindicate arthroscopic rotator cuff surgery
* patients without complete osteogenesis
* pregnant or breastfeeding women
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ASST Gaetano Pini-CTO

OTHER

Sponsor Role lead

Responsible Party

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Roberto Leo

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Roberto Leo

Milan, , Italy

Site Status

Countries

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Italy

Facility Contacts

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Roberto Leo

Role: primary

Valentina Fogliata

Role: backup

Other Identifiers

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753_2016

Identifier Type: -

Identifier Source: org_study_id