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Bursa Augmentation in Arthroscopic Rotator Cuff Repair

Not Applicable
Completed
Conditions
Rotator Cuff Tear or Rupture, Not Specified as Traumatic
Interventions
Procedure: Doppler ultrasonography after bursa augmentation
Registration Number
NCT03986749
Lead Sponsor
Schulthess Klinik
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
30
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Arm && Interventions
GroupInterventionDescription
ARCR-BursaSeriesDoppler ultrasonography after bursa augmentationTendon healing in the reconstruction of the rotator cuff, taking advantage of augmentation potential of the subacromial bursa.
Primary Outcome Measures
NameTimeMethod
Dynamic ultrasound examination with grading of blood vessels3 months

using the modified Ohberg Score

Secondary Outcome Measures
NameTimeMethod
Tendon condition6 months

Thickness of the repaired tendons (mm)

Subjective shoulder value (SSV)6 months

Patient-reported Subjective shoulder value from 0 (worse) to 100% (best)

Oxford Shoulder Score (OSS)6 months

Patient-reported Oxford Shoulder Score from 0 (worse) to 48 (best)

Level of satisfaction6 months

Level of satisfaction using Number Rating Scale from 0 (not satisfied) to 10 (highly satisfied)

Tendon integrity6 months

intact / partially ruptured / ruptured

Range of motion6 months

Elevation (flexion), abduction, external rotation by 0° abduction, external-internal rotation by 90° abduction

Shoulder muscle strength6 months

Shoulder strength in 90° Abduction (kg) measured using a spring balance

Constant Murley score (CMS)6 months

Constant Murley functional score from 0 (worse) to 100 (best)

EQ-5D utilities6 months

Patient-reported Quality of life (EuroQol EQ-5D-5L) as Utility index from 0 (worse) to 1 (best health)

Adverse events6 months

Number of patients with adverse events

Trial Locations

Locations (1)

Schulthess Klinik

🇨🇭

Zürich, ZH, Switzerland

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