Bursa Augmentation in Arthroscopic Rotator Cuff Repair
- 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
- 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
- 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
Group Intervention Description ARCR-BursaSeries Doppler ultrasonography after bursa augmentation Tendon healing in the reconstruction of the rotator cuff, taking advantage of augmentation potential of the subacromial bursa.
- Primary Outcome Measures
Name Time Method Dynamic ultrasound examination with grading of blood vessels 3 months using the modified Ohberg Score
- Secondary Outcome Measures
Name Time Method Tendon condition 6 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 satisfaction 6 months Level of satisfaction using Number Rating Scale from 0 (not satisfied) to 10 (highly satisfied)
Tendon integrity 6 months intact / partially ruptured / ruptured
Range of motion 6 months Elevation (flexion), abduction, external rotation by 0° abduction, external-internal rotation by 90° abduction
Shoulder muscle strength 6 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 utilities 6 months Patient-reported Quality of life (EuroQol EQ-5D-5L) as Utility index from 0 (worse) to 1 (best health)
Adverse events 6 months Number of patients with adverse events
Trial Locations
- Locations (1)
Schulthess Klinik
🇨🇭Zürich, ZH, Switzerland