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NCT03060928 Clinical Trial

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

Rotator Cuff Tear Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03060928
Other study ID # 753_2016
Secondary ID
Status Not yet recruiting
Phase N/A
First received February 19, 2017
Last updated February 27, 2017
Start date March 1, 2017
Est. completion date December 31, 2020

Study information
Verified date February 2017
Source ASST Gaetano Pini-CTO
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 240
Est. completion date December 31, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Arthroscopic Rotator Cuff Repair
Arthroscopic Rotator Cuff Repair
• Micro-perforations
Biological stimulation with micro-perforations
• Artelon®
Biological stimulation with Artelon® Tissue Reinforcement

Locations
Country Name City State
Italy Roberto Leo Milano

Sponsors (1)
Lead Sponsor Collaborator
ASST Gaetano Pini-CTO

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Retear rate Comparison of re-ruptures rate in each group evaluated with magnetic resonance imaging 12 months post-operatively
Secondary Constant-Murley Comparison of Constant-Murley Score in each group 3, 6, 12 months post-operatively
Secondary DASH Comparison of DASH Score in each group 1, 3, 6, 12 months post-operatively
Secondary VAS Comparison of Visual Analogue Scale (VAS) in each group 1, 3, 6, 12 months post-operatively
Secondary Passive ROM Comparison of passive range of motion in each group 1, 3, 6, 12 months post-operatively
Secondary Adverse events Adverse events for any cause 1, 3, 6, 12 months post-operatively
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