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

February 27, 2017 updated by: Roberto Leo, ASST Gaetano Pini-CTO

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milano, Italy
        • Roberto Leo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Control
Arthroscopic Rotator Cuff Repair with standard treatment
Procedure: Arthroscopic Rotator Cuff Repair
Arthroscopic Rotator Cuff Repair
EXPERIMENTAL: Experimental 1
Arthroscopic Rotator Cuff Repair with standard treatment + biological stimulation with micro-perforations
Procedure: Arthroscopic Rotator Cuff Repair
Arthroscopic Rotator Cuff Repair
Procedure: Micro-perforations
Biological stimulation with micro-perforations
EXPERIMENTAL: Experimental 2
Arthroscopic Rotator Cuff Repair with standard treatment + biological stimulation with the combination of micro-perforations and use of Artelon® Tissue Reinforcement
Procedure: Arthroscopic Rotator Cuff Repair
Arthroscopic Rotator Cuff Repair
Procedure: Micro-perforations
Biological stimulation with micro-perforations
Procedure: Artelon®
Biological stimulation with Artelon® Tissue Reinforcement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retear rate
Time Frame: 12 months post-operatively
Comparison of re-ruptures rate in each group evaluated with magnetic resonance imaging
12 months post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Constant-Murley
Time Frame: 3, 6, 12 months post-operatively
Comparison of Constant-Murley Score in each group
3, 6, 12 months post-operatively
DASH
Time Frame: 1, 3, 6, 12 months post-operatively
Comparison of DASH Score in each group
1, 3, 6, 12 months post-operatively
VAS
Time Frame: 1, 3, 6, 12 months post-operatively
Comparison of Visual Analogue Scale (VAS) in each group
1, 3, 6, 12 months post-operatively
Passive ROM
Time Frame: 1, 3, 6, 12 months post-operatively
Comparison of passive range of motion in each group
1, 3, 6, 12 months post-operatively
Adverse events
Time Frame: 1, 3, 6, 12 months post-operatively
Adverse events for any cause
1, 3, 6, 12 months post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ASST Gaetano Pini-CTO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 1, 2017

Primary Completion (ANTICIPATED)

December 31, 2019

Study Completion (ANTICIPATED)

December 31, 2020

Study Registration Dates

First Submitted

February 19, 2017

First Submitted That Met QC Criteria

February 21, 2017

First Posted (ACTUAL)

February 23, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 28, 2017

Last Update Submitted That Met QC Criteria

February 27, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 753_2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rotator Cuff Tear

Clinical Trials on Arthroscopic Rotator Cuff Repair

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe