Arthroscopic Rotator Cuff Reconstruction With or Without Biologic or Synthetic Patch Augmentation in Patients Over 60 Years: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Schulthess Klinik
- Primary Endpoint
- Occurrence of retear
Study Overview
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Intervention group 1: Pitch-Patch
Reconstruction with patch augmentation using a synthetic patch
Intervention: Pitch Patch (Device)
Intervention group 2: ArthroFlex
Reconstruction with patch augmentation using a biological human dermis patch
Intervention: ArthroFlex (Device)
Control
Outcomes
Primary Outcomes
Occurrence of retear
Time Frame: 24 months
Repair integrity will be assessed by an independent assessor on the basis of centralized MRI images.
Secondary Outcomes
- 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)
- Subjective shoulder value (SSV)(6/24 months)
- Quality of life (utilities) and general health using EQ-5D-5L(6/24 months)
- Subjective improvement, expectation, satisfaction with treatment(6/24 months)
- Adverse events / complications(3/6/24 months and intra-operative)