Bursa Augmentation in Arthroscopic Rotator Cuff Repair

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2023-08-22

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.

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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.

Conditions

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Rotator Cuff Tear or Rupture, Not Specified as Traumatic

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

prospective observational case-series

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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ARCR-BursaSeries

Tendon healing in the reconstruction of the rotator cuff, taking advantage of augmentation potential of the subacromial bursa.

Group Type EXPERIMENTAL

Doppler ultrasonography after bursa augmentation

Intervention Type PROCEDURE

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.

Interventions

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Doppler ultrasonography after bursa augmentation

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.

Intervention Type PROCEDURE

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