NCT03060928

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

February 28, 2017

Status Verified

February 1, 2017

Enrollment Period

2.8 years

First QC Date

February 19, 2017

Last Update Submit

February 27, 2017

Conditions

Rotator Cuff Tear

Keywords

Rotator Cuff TearArtelon®

Outcome Measures

Primary Outcomes (1)

  • Retear rate

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

    12 months post-operatively

Secondary Outcomes (5)

  • Constant-Murley

    3, 6, 12 months post-operatively

  • DASH

    1, 3, 6, 12 months post-operatively

  • VAS

    1, 3, 6, 12 months post-operatively

  • Passive ROM

    1, 3, 6, 12 months post-operatively

  • Adverse events

    1, 3, 6, 12 months post-operatively

Study Arms (3)

Control

ACTIVE COMPARATOR

Arthroscopic Rotator Cuff Repair with standard treatment

Procedure: Arthroscopic Rotator Cuff Repair

Experimental 1

EXPERIMENTAL

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

Procedure: Arthroscopic Rotator Cuff RepairProcedure: Micro-perforations

Experimental 2

EXPERIMENTAL

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 RepairProcedure: Micro-perforationsProcedure: Artelon®

Interventions

Arthroscopic Rotator Cuff RepairPROCEDURE

Arthroscopic Rotator Cuff Repair

ControlExperimental 1Experimental 2
Micro-perforationsPROCEDURE

Biological stimulation with micro-perforations

Experimental 1Experimental 2
Artelon®PROCEDURE

Biological stimulation with Artelon® Tissue Reinforcement

Experimental 2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Roberto Leo

Milan, Italy

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

polyetherurethane urea

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double Blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 19, 2017

First Posted

February 23, 2017

Study Start

March 1, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2020

Last Updated

February 28, 2017

Record last verified: 2017-02

Locations

IT(1)