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Trial record 41 of 138 for:    Recruiting, Not yet recruiting, Available Studies | "Lacerations"

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

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ClinicalTrials.gov Identifier: NCT03060928
Recruitment Status : Not yet recruiting
First Posted : February 23, 2017
Last Update Posted : February 28, 2017
Sponsor:
Information provided by (Responsible Party):
Roberto Leo, ASST Gaetano Pini-CTO

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.


Condition or disease Intervention/treatment Phase
Rotator Cuff Tear Procedure: Arthroscopic Rotator Cuff Repair Procedure: Micro-perforations Procedure: Artelon® Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double Blind
Primary Purpose: Treatment
Official Title: Evaluation of Tendon-to-Bone Healing Potential in Arthroscopic Rotator Cuff Repair Through Biological Stimulation
Estimated Study Start Date : March 1, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

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




Primary Outcome Measures :
  1. Retear rate [ Time Frame: 12 months post-operatively ]
    Comparison of re-ruptures rate in each group evaluated with magnetic resonance imaging


Secondary Outcome Measures :
  1. Constant-Murley [ Time Frame: 3, 6, 12 months post-operatively ]
    Comparison of Constant-Murley Score in each group

  2. DASH [ Time Frame: 1, 3, 6, 12 months post-operatively ]
    Comparison of DASH Score in each group

  3. VAS [ Time Frame: 1, 3, 6, 12 months post-operatively ]
    Comparison of Visual Analogue Scale (VAS) in each group

  4. Passive ROM [ Time Frame: 1, 3, 6, 12 months post-operatively ]
    Comparison of passive range of motion in each group

  5. Adverse events [ Time Frame: 1, 3, 6, 12 months post-operatively ]
    Adverse events for any cause



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03060928


Locations
Italy
Roberto Leo Not yet recruiting
Milano, Italy
Contact: Roberto Leo    0258296798    spallagomito@gmail.com   
Contact: Valentina Fogliata       dottoressa.fogliata@gmail.com   
Principal Investigator: Roberto Leo         
Sub-Investigator: Valentina Fogliata         
Sub-Investigator: Bruno Michele Marelli         
Sponsors and Collaborators
ASST Gaetano Pini-CTO

Responsible Party: Roberto Leo, MD, ASST Gaetano Pini-CTO
ClinicalTrials.gov Identifier: NCT03060928     History of Changes
Other Study ID Numbers: 753_2016
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Roberto Leo, ASST Gaetano Pini-CTO:
Rotator Cuff Tear
Artelon®

Additional relevant MeSH terms:
Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries