Comparison of Arthroscopic Supraspinatus Tendon Tear Repair in Patients Over 60 Years With and Without Patch Augmentation.

NCT03511547 | Withdrawn DMC

• 1 other identifier: ARCR-RCT
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the study is to show that patch augmentation in rotatorcuff tear results in lower rate of recurrent tendon defects compared without patches.

Conditions

Rotator Cuff Tears

Outcome Measures

Primary Outcomes (1)

• Occurrence of retear

  Repair integrity will be assessed by an independent assessor on the basis of centralized MRI images.

  24 months

Secondary Outcomes (9)

• Pain level (NRS)

  6/24 months

• Range of motion (flexion, abduction, external and internal rotation)

  6/24 months

• Shoulder strength in 90° abduction and in external rotation (0° abduction)

  6/24 months

• Constant Murley Score (CS)

  6/24 months

• Oxford Shoulder Score (OSS)

  6/24 months

Study Arms (3)

Intervention group 1: Pitch-Patch

ACTIVE COMPARATOR

Reconstruction with patch augmentation using a synthetic patch

Device: Pitch Patch

Intervention group 2: ArthroFlex

ACTIVE COMPARATOR

Reconstruction with patch augmentation using a biological human dermis patch

Device: ArthroFlex

Control

NO INTERVENTION

Interventions

Pitch Patch DEVICE

The patients will be operated by shoulder arthroscopy according to the internationally standardized procedure. Patients allocated this group will receive a synthetic (Pitch-Patch™ \[PP\]) augmentation.

Intervention group 1: Pitch-Patch

ArthroFlex DEVICE

The patients will be operated by shoulder arthroscopy according to the internationally standardized procedure. Patients allocated this group will receive a biologic patch (ArthroFlex® \[AF\]) augmentation.

Intervention group 2: ArthroFlex

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Rotator cuff tear \> 2 cm in the sagittal plane involving the supraspinatus tendon as well as at least the superior 1/3 of the infraspinatus tendon
• Indicated for surgical reconstruction by arthroscopy
• Patient aged 60 years and over
• Consenting participation in this study by signing the Informed Consent form

You may not qualify if:

• Osteoarthritis (grade ≥ 2 after Samilson \& Prieto)
• Advanced fatty infiltration of the rotator cuff muscles (Goutallier grade III or IV)
• Tear of the subscapularis \> Typ 1 Lafosse (partial tears of superior 1/3 of the tendon)
• Irreparable tear of the supraspinatus
• General medical contraindication to surgery
• Known hypersensitivity to the materials used
• Revision operations
• Open reconstruction
• Tendon transfer necessary (latissimus dorsi or pectoralis major)
• Any disease process that would preclude accurate evaluation including:
• Systemic arthritis, rheumatoid arthritis, diabetes (insulin dependent), acute or chronic infection, abnormal bone metabolism, tumour / malignoma, psychiatric disorder
• Inadequate blood flow or neuromuscular disease in the affected arm
• Recent history of substance abuse
• Legal incompetence
• German language barrier to complete the questionnaires or

Sponsors & Collaborators

• Schulthess Klinik: lead

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Markus Scheibel, Prof

  Schulthess Klinik

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2018
• First Posted: April 30, 2018
• Study Start: January 1, 2018
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: October 22, 2020

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share