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

Schulthess Klinik

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Rotator Cuff Tears

Interventions

Pitch PatchDEVICE

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.

ArthroFlexDEVICE

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.

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Occurrence of retear

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

Time frame: 24 months

Secondary Outcomes

Pain level (NRS)

The pain level in the operated shoulder will be measured with a numeric rating scale (0=no pain, 10 = maximum pain) as part as the Constant Murley Score (CS)

Time frame: 6/24 months

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

The following active and passive range of motion parameters of the affected shoulder will be documented using a goniometer : Elevation (flexion), abduction, External rotation by 0° abduction, external-internal rotation by 90° abduction

Time frame: 6/24 months

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

The shoulder strenght will be measured with an isobex device

Time frame: 6/24 months

Constant Murley Score (CS)

The CMS is a 100-point scoring system that is divided into four subscales: pain (15 points), activities of daily living (20 points), range of motion (40 points) and strength (25 points).Pain and activities of daily living are self-reported by the patient using visual analog scales and ordinal categories. Range of motion is obtained during active painfree elevation in flexion and abduction (using a goniometer), and functional internal and external rotation of the shoulder (using ordinal scale). Strength testing was performed at 90° of abduction in the scapular plane.

Time frame: 6/24 months

Oxford Shoulder Score (OSS)

The Oxford Shoulder Score used after 3 months is the primary parameter. The Score tests the ability to participate in the patients' normal life before they got injured.

Data from ClinicalTrials.gov

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