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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 31, 2019

Interventions

  • 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

Arms, Groups and Cohorts

  • Active Comparator: Control
    • Arthroscopic Rotator Cuff Repair with standard treatment
  • Experimental: Experimental 1
    • Arthroscopic Rotator Cuff Repair with standard treatment + 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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • ASST Gaetano Pini-CTO
  • Provider of Information About this Clinical Study
    • Principal Investigator: Roberto Leo, MD – ASST Gaetano Pini-CTO

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.