Bursa Augmentation in Arthroscopic Rotator Cuff Repair

Study Overview
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Brief Summary
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The aim of this first study is to investigate in a case series through sequential sonographic imaging, using Doppler ultrasonography, the postoperative morphology, especially vascularity and findings of neovascularity, after bursa augmentation in arthroscopic rotator cuff repair.

Detailed Description
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The outcome of rotator cuff (RC) reconstruction with and without bursa augmentation, considering also the inflammatory status of the bursa, will be systematically investigated for the first time. The influencing role of the inflammatory status of the bursa, of the RC tendon and the synovial membrane at the time of the operation on the tendinous healing rate, the patient-relevant outcome factors and the revision rate will be assessed. In a further approach, basic knowledge about the role of bursa inflammation and its influence in the development and regeneration of tendon pathologies shall be gained. The findings of the whole project could lead to improve tendon healing in the reconstruction of the rotator cuff, taking advantage of augmentation potential of the subacromial bursa.

Official Title
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Biological Augmentation With Subacromial Bursa in Arthroscopic Rotator Cuff Repair - Postoperative Findings Using Doppler Ultrasonography

Conditions
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Rotator Cuff Tear or Rupture, Not Specified as Traumatic

Intervention / Treatment
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* Procedure: Doppler ultrasonography after bursa augmentation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient aged 18 years and older Patient with C-shaped posterosuperior rotator cuff tear (SSP / ± ISP, ± SCP Tear Lafosse ≤ 1 (SCP no repair, only debridement)) Retraction ≤ 2 according to Patte Fatty infiltration ≤ 2 according to Goutallier Eligible for arthroscopic double row rotator cuff repair in Suture Bridge technique. Written informed consent Exclusion Criteria: Legal incompetence Last subacromial cortisone infiltration ≤ 6 months Systemic rheumatologic-inflammatory disease Diabetes Mellitus Smoker
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Sequential Assignment
Interventional Model Description: prospective observational case-series
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARCR-BursaSeries<br>Tendon healing in the reconstruction of the rotator cuff, taking advantage of augmentation potential of the subacromial bursa. | Procedure: Doppler ultrasonography after bursa augmentation<br>* Dynamic ultrasound examination with Grading of blood vessels using the modified Ohberg Score in the longitudinal scan in dynamic ultrasound of the rotator cuff tendon - primary to surgery and 3 weeks later.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dynamic ultrasound examination with grading of blood vessels | using the modified Ohberg Score | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tendon integrity | intact / partially ruptured / ruptured | 6 months | 
| Tendon condition | Thickness of the repaired tendons (mm) | 6 months | 
| Range of motion | Elevation (flexion), abduction, external rotation by 0° abduction, external-internal rotation by 90° abduction | 6 months | 
| Shoulder muscle strength | Shoulder strength in 90° Abduction (kg) measured using a spring balance | 6 months | 
| Oxford Shoulder Score (OSS) | Patient-reported Oxford Shoulder Score from 0 (worse) to 48 (best) | 6 months | 
| Subjective shoulder value (SSV) | Patient-reported Subjective shoulder value from 0 (worse) to 100% (best) | 6 months | 
| Constant Murley score (CMS) | Constant Murley functional score from 0 (worse) to 100 (best) | 6 months | 
| Level of satisfaction | Level of satisfaction using Number Rating Scale from 0 (not satisfied) to 10 (highly satisfied) | 6 months | 
| EQ-5D utilities | Patient-reported Quality of life (EuroQol EQ-5D-5L) as Utility index from 0 (worse) to 1 (best health) | 6 months | 
| Adverse events | Number of patients with adverse events | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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arthroscopic rotator cuff repair, bursa augmentation, neovascularization, Doppler ultrasonography