Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.

Condition or disease Intervention/treatment Phase
Rotator Cuff Tear or Rupture, Not Specified as Traumatic Procedure: Doppler ultrasonography after bursa augmentation Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Sequential Assignment
Intervention Model Description: prospective observational case-series
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Biological Augmentation With Subacromial Bursa in Arthroscopic Rotator Cuff Repair - Postoperative Findings Using Doppler Ultrasonography
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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.




Primary Outcome Measures :
  1. Dynamic ultrasound examination with grading of blood vessels [ Time Frame: 3 months ]
    using the modified Ohberg Score


Secondary Outcome Measures :
  1. Tendon integrity [ Time Frame: 6 months ]
    intact / partially ruptured / ruptured

  2. Tendon condition [ Time Frame: 6 months ]
    Thickness of the repaired tendons (mm)

  3. Range of motion [ Time Frame: 6 months ]
    Elevation (flexion), abduction, external rotation by 0° abduction, external-internal rotation by 90° abduction

  4. Shoulder muscle strength [ Time Frame: 6 months ]
    Shoulder strength in 90° Abduction (kg) measured using a spring balance

  5. Oxford Shoulder Score (OSS) [ Time Frame: 6 months ]
    Patient-reported Oxford Shoulder Score from 0 (worse) to 48 (best)

  6. Subjective shoulder value (SSV) [ Time Frame: 6 months ]
    Patient-reported Subjective shoulder value from 0 (worse) to 100% (best)

  7. Constant Murley score (CMS) [ Time Frame: 6 months ]
    Constant Murley functional score from 0 (worse) to 100 (best)

  8. Level of satisfaction [ Time Frame: 6 months ]
    Level of satisfaction using Number Rating Scale from 0 (not satisfied) to 10 (highly satisfied)

  9. 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)

  10. Adverse events [ Time Frame: 6 months ]
    Number of patients with adverse events



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986749


Contacts
Layout table for location contacts
Contact: Laurent Audigé, PhD +41 44 385 7580 laurent.audige@kws.ch

Sponsors and Collaborators
Schulthess Klinik
Investigators
Layout table for investigator information
Principal Investigator: Markus Scheibel, MD Schulthess Klinik

Layout table for additonal information
Responsible Party: Schulthess Klinik
ClinicalTrials.gov Identifier: NCT03986749     History of Changes
Other Study ID Numbers: OE-0116 (ARCR-BursaSeries)
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Schulthess Klinik:
arthroscopic rotator cuff repair
bursa augmentation
neovascularization
Doppler ultrasonography

Additional relevant MeSH terms:
Layout table for MeSH terms
Rupture
Rotator Cuff Injuries
Wounds and Injuries
Shoulder Injuries
Tendon Injuries