Bursa Augmentation in Arthroscopic Rotator Cuff Repair (ARCR-Bursa)

Schulthess Klinik

Status: Completed

Conditions: Rotator Cuff Tear or Rupture, Not Specified as Traumatic

Treatments: Procedure: Doppler ultrasonography after bursa augmentation

Study type: Interventional

Funder types: Other

Identifiers

NCT03986749

OE-0116 (ARCR-BursaSeries)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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30 participants in 1 patient group

ARCR-BursaSeries

Experimental group

Description:

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

Treatment:

Procedure: Doppler ultrasonography after bursa augmentation