Clinical trial NCT03986749: Bursa Augmentation in Arthroscopic Rotator Cuff Repair
Official title: Biological Augmentation With Subacromial Bursa in Arthroscopic Rotator Cuff Repair - Postoperative Findings Using Doppler Ultrasonography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tear or Rupture, Not Specified as Traumatic
Keywords: arthroscopic rotator cuff repair
bursa augmentation
neovascularization
Doppler ultrasonography
Lead sponsor: Schulthess Klinik
Sponsor class: OTHER
First posted: 2019-06-14
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: prospective observational case-series
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Dynamic ultrasound examination with grading of blood vessels
timeFrame: 3 months
Secondary outcomes:
measure: Tendon integrity
timeFrame: 6 months
measure: Tendon condition
timeFrame: 6 months
measure: Range of motion
timeFrame: 6 months
measure: Shoulder muscle strength
timeFrame: 6 months
measure: Oxford Shoulder Score (OSS)
timeFrame: 6 months
measure: Subjective shoulder value (SSV)
timeFrame: 6 months
measure: Constant Murley score (CMS)
timeFrame: 6 months
measure: Level of satisfaction
timeFrame: 6 months
measure: EQ-5D utilities
timeFrame: 6 months
measure: Adverse events
timeFrame: 6 months
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Schulthess Klinik
state: ZH
Study officials:
affiliation: Schulthess Klinik
name: Markus Scheibel, MD
role: PRINCIPAL_INVESTIGATOR
References: