Bursa Augmentation in Arthroscopic Rotator Cuff Repair

Rotator Cuff Tear or Rupture, Not Specified as Traumatic Clinical Trial

— ARCR-Bursa  

Official title:

Biological Augmentation With Subacromial Bursa in Arthroscopic Rotator Cuff Repair - Postoperative Findings Using Doppler Ultrasonography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03986749
• Other study ID #: OE-0116 (ARCR-BursaSeries)
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: August 22, 2023

Study information

• Verified date: May 2024
• Source: Schulthess Klinik
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 22, 2023
• Est. primary completion date: August 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tear or Rupture, Not Specified as Traumatic
• Rupture

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Switzerland	Schulthess Klinik	Zürich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
Schulthess Klinik

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dynamic ultrasound examination with grading of blood vessels	using the modified Ohberg Score	3 months
Secondary	Tendon integrity	intact / partially ruptured / ruptured	6 months
Secondary	Tendon condition	Thickness of the repaired tendons (mm)	6 months
Secondary	Range of motion	Elevation (flexion), abduction, external rotation by 0° abduction, external-internal rotation by 90° abduction	6 months
Secondary	Shoulder muscle strength	Shoulder strength in 90° Abduction (kg) measured using a spring balance	6 months
Secondary	Oxford Shoulder Score (OSS)	Patient-reported Oxford Shoulder Score from 0 (worse) to 48 (best)	6 months
Secondary	Subjective shoulder value (SSV)	Patient-reported Subjective shoulder value from 0 (worse) to 100% (best)	6 months
Secondary	Constant Murley score (CMS)	Constant Murley functional score from 0 (worse) to 100 (best)	6 months
Secondary	Level of satisfaction	Level of satisfaction using Number Rating Scale from 0 (not satisfied) to 10 (highly satisfied)	6 months
Secondary	EQ-5D utilities	Patient-reported Quality of life (EuroQol EQ-5D-5L) as Utility index from 0 (worse) to 1 (best health)	6 months
Secondary	Adverse events	Number of patients with adverse events	6 months