Clinical Trials Logo
  1. Home
  2. Rotator Cuff Tear
  3. NCT03060928
  4. Details
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
See also
  Status Clinical Trial Phase
Withdrawn NCT03319784 - Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients Phase 4
Completed NCT03663036 - Arthroscopic Superior Capsular Reconstruction With Fascia Lata Autograft - Survivorship of the Autograft Analysis N/A
Suspended NCT03290196 - The Effect of EXPAREL® on Postsurgical Pain, and the Use of Narcotics Phase 4
Active, not recruiting NCT03091075 - Oxandrolone Rotator Cuff Trial N/A
Completed NCT03380533 - Buprenorphine Transdermal Patches in Arthroscopic Rotator Cuff Repair Phase 2/Phase 3
Completed NCT04566939 - A Long Term Follow-Up of Rotator Cuff Tear Patients Treated With Integrated Complementary and Alternative Medicine
Active, not recruiting NCT02716441 - Rotator Cuff Failure With Continuity
Completed NCT03540030 - Opioid-Free Shoulder Arthroplasty Phase 4
Completed NCT02298023 - Treatment of Tendon Injury Using Allogenic Adipose-derived Mesenchymal Stem Cells (Rotator Cuff Tear) Phase 2
Completed NCT01383239 - Impact of Postoperative Management on Outcomes and Healing of Rotator Cuff Repairs N/A
Completed NCT01459536 - Assessment of Muscle Function and Size in Older Adults With Rotator Cuff Tear N/A
Completed NCT02850211 - A Selective COX-2 Inhibitor Provides Pain Control But Hinders Healing Following Arthroscopic Rotator Cuff Repair Phase 4
Completed NCT01170312 - Arthroscopic Surgery and Platelet Rich Plasma In Rotator Cuff Tear Evaluation N/A
Completed NCT01204606 - Arthroscopic Rotator Cuff Repair With Multimodal Analgesia(MMA) N/A
Terminated NCT00936559 - Study Evaluating Safety Of BMP-655/ACS As An Adjuvant Therapy For Rotator Cuff Repair Phase 1
Completed NCT00852657 - Comparison of Tendon Repair and Physiotherapy in the Treatment of Small and Medium-sized Tears of the Rotator Cuff N/A
Active, not recruiting NCT00182299 - An RCT to Compare the Outcomes of Patients With Large Rotator Cuff Repair That Undergo Repair With or Without SIS Phase 4
Recruiting NCT06120998 - Quality of Life After Arthroscopic Rotator Cuff Repair
Completed NCT05897866 - Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management (HSSM) N/A
Completed NCT02644564 - Early Clinical Examination and Ultrasonography Screening of Acute Soft Tissue Shoulder Injuries N/A