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

Primary Purpose

Rotator Cuff Tear

Status

Unknown status

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Arthroscopic Rotator Cuff Repair

Micro-perforations

Artelon®

About this trial

This is an interventional treatment trial for Rotator Cuff Tear focused on measuring Rotator Cuff Tear, Artelon®

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Roberto Leo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Control

Experimental 1

Experimental 2

Arm Description

Arthroscopic Rotator Cuff Repair with standard treatment

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

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

Outcomes

Primary Outcome Measures

Retear rate

Comparison of re-ruptures rate in each group evaluated with magnetic resonance imaging

Secondary Outcome Measures

Constant-Murley

Comparison of Constant-Murley Score in each group

DASH

Comparison of DASH Score in each group

VAS

Comparison of Visual Analogue Scale (VAS) in each group

Passive ROM

Comparison of passive range of motion in each group

Adverse events

Adverse events for any cause

Full Information

NCT ID

NCT03060928

First Posted

February 19, 2017

Last Updated

February 27, 2017

Sponsor

ASST Gaetano Pini-CTO

1. Study Identification

Unique Protocol Identification Number

NCT03060928

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Unknown status

Study Start Date

March 1, 2017 (Anticipated)

Primary Completion Date

December 31, 2019 (Anticipated)

Study Completion Date

December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

ASST Gaetano Pini-CTO

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rotator Cuff Tear

Keywords

Rotator Cuff Tear, Artelon®

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Double Blind

Allocation

Randomized

Enrollment

240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

Active Comparator

Arm Description

Arthroscopic Rotator Cuff Repair with standard treatment

Arm Title

Experimental 1

Arm Type

Experimental

Arm Description

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

Arm Title

Experimental 2

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Arthroscopic Rotator Cuff Repair

Intervention Description

Arthroscopic Rotator Cuff Repair

Intervention Type

Procedure

Intervention Name(s)

Micro-perforations

Intervention Description

Biological stimulation with micro-perforations

Intervention Type

Procedure

Intervention Name(s)

Artelon®

Intervention Description

Biological stimulation with Artelon® Tissue Reinforcement

Primary Outcome Measure Information:

Title

Retear rate

Description

Comparison of re-ruptures rate in each group evaluated with magnetic resonance imaging

Time Frame

12 months post-operatively

Secondary Outcome Measure Information:

Title

Constant-Murley

Description

Comparison of Constant-Murley Score in each group

Time Frame

3, 6, 12 months post-operatively

Title

DASH

Description

Comparison of DASH Score in each group

Time Frame

1, 3, 6, 12 months post-operatively

Title

VAS

Description

Comparison of Visual Analogue Scale (VAS) in each group

Time Frame

1, 3, 6, 12 months post-operatively

Title

Passive ROM

Description

Comparison of passive range of motion in each group

Time Frame

1, 3, 6, 12 months post-operatively

Title

Adverse events

Description

Adverse events for any cause

Time Frame

1, 3, 6, 12 months post-operatively

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Roberto Leo

City

Milano

Country

Italy

Facility Contact: