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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Rotator Cuff Tear or Rupture, Not Specified as Traumatic
• Intervention / Treatment: Procedure: Doppler ultrasonography after bursa augmentation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laurent Audigé, PhD; Phone Number: +41 44 385 7580; Email: laurent.audige@kws.ch

Study Locations

• Switzerland
  • ZH
    • Zürich, ZH, Switzerland, 8008
      • Recruiting
      • Schulthess Klinik
      • Contact: Markus Scheibel, MD; Phone Number: +41443857468; Email: markus.scheibel@kws.ch
      • Contact: Laurent Auduigé, PhD; Phone Number: +41443857580; Email: laurent.audige@kws.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ARCR-BursaSeries; Tendon healing in the reconstruction of the rotator cuff, taking advantage of augmentation potential of the subacromial bursa.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dynamic ultrasound examination with grading of blood vessels	using the modified Ohberg Score	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Schulthess Klinik
• Investigators: Principal Investigator: Markus Scheibel, MD, Schulthess Klinik

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: June 5, 2019
• First Submitted That Met QC Criteria: June 11, 2019
• First Posted (Actual): June 14, 2019

Study Record Updates

• Last Update Posted (Actual): November 16, 2022
• Last Update Submitted That Met QC Criteria: November 15, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: arthroscopic rotator cuff repair; neovascularization; bursa augmentation; Doppler ultrasonography
• Additional Relevant MeSH Terms: Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries; Rupture
• Other Study ID Numbers: OE-0116 (ARCR-BursaSeries)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No