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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03986749
Recruitment Status : Not yet recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Schulthess Klinik

Tracking Information
First Submitted Date  ICMJE June 5, 2019
First Posted Date  ICMJE June 14, 2019
Last Update Posted Date June 14, 2019
Estimated Study Start Date  ICMJE July 2019
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
Dynamic ultrasound examination with grading of blood vessels [ Time Frame: 3 months ]
using the modified Ohberg Score
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
  • Tendon integrity [ Time Frame: 6 months ]
    intact / partially ruptured / ruptured
  • Tendon condition [ Time Frame: 6 months ]
    Thickness of the repaired tendons (mm)
  • Range of motion [ Time Frame: 6 months ]
    Elevation (flexion), abduction, external rotation by 0° abduction, external-internal rotation by 90° abduction
  • Shoulder muscle strength [ Time Frame: 6 months ]
    Shoulder strength in 90° Abduction (kg) measured using a spring balance
  • Oxford Shoulder Score (OSS) [ Time Frame: 6 months ]
    Patient-reported Oxford Shoulder Score from 0 (worse) to 48 (best)
  • Subjective shoulder value (SSV) [ Time Frame: 6 months ]
    Patient-reported Subjective shoulder value from 0 (worse) to 100% (best)
  • Constant Murley score (CMS) [ Time Frame: 6 months ]
    Constant Murley functional score from 0 (worse) to 100 (best)
  • Level of satisfaction [ Time Frame: 6 months ]
    Level of satisfaction using Number Rating Scale from 0 (not satisfied) to 10 (highly satisfied)
  • EQ-5D utilities [ Time Frame: 6 months ]
    Patient-reported Quality of life (EuroQol EQ-5D-5L) as Utility index from 0 (worse) to 1 (best health)
  • Adverse events [ Time Frame: 6 months ]
    Number of patients with adverse events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bursa Augmentation in Arthroscopic Rotator Cuff Repair
Official Title  ICMJE Biological Augmentation With Subacromial Bursa in Arthroscopic Rotator Cuff Repair - Postoperative Findings Using Doppler Ultrasonography
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Sequential Assignment
Intervention Model Description:
prospective observational case-series
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Rotator Cuff Tear or Rupture, Not Specified as Traumatic
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: ARCR-BursaSeries
Tendon healing in the reconstruction of the rotator cuff, taking advantage of augmentation potential of the subacromial bursa.
Intervention: Procedure: Doppler ultrasonography after bursa augmentation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 11, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2019
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Laurent Audigé, PhD +41 44 385 7580 laurent.audige@kws.ch
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03986749
Other Study ID Numbers  ICMJE OE-0116 (ARCR-BursaSeries)
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Schulthess Klinik
Study Sponsor  ICMJE Schulthess Klinik
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Markus Scheibel, MD Schulthess Klinik
PRS Account Schulthess Klinik
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP