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

Schulthess Klinik

Status: Withdrawn

Conditions: Rotator Cuff Tears

Treatments: Device: ArthroFlex; Device: Pitch Patch

Study type: Interventional

Funder types: Other

Identifiers

NCT03511547

ARCR-RCT

Details and patient eligibility

About

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.

Full description

An arthroscopic rotator cuff repair is nowadays mostly implemented in order to restore function and reduce or eliminate pain. The primary objective of this randomized controlled trial is to demonstrate, in patients 60 years or older with a large rotator cuff tear, that biological or synthetic patch augmen-tation in arthroscopic rotator cuff repair results in decreased rate of retear 24 months post-operatively compared to re-pair without patch augmentation.

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

• Participation in any other medical device or medicinal product study that could influence the results of the present study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Intervention group 1: Pitch-Patch

Active Comparator group

Description:

Reconstruction with patch augmentation using a synthetic patch

Treatment:

Device: Pitch Patch

Intervention group 2: ArthroFlex

Active Comparator group

Description:

Reconstruction with patch augmentation using a biological human dermis patch

Treatment:

Device: ArthroFlex

Control

No Intervention group