NCT03986749

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 14, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2023

Completed
Last Updated

June 3, 2024

Status Verified

May 1, 2024

Enrollment Period

3.9 years

First QC Date

June 5, 2019

Last Update Submit

May 31, 2024

Conditions

Rotator Cuff Tear or Rupture, Not Specified as Traumatic

Keywords

arthroscopic rotator cuff repairbursa augmentationneovascularizationDoppler ultrasonography

Outcome Measures

Primary Outcomes (1)

  • Dynamic ultrasound examination with grading of blood vessels

    using the modified Ohberg Score

    3 months

Secondary Outcomes (10)

  • Tendon integrity

    6 months

  • Tendon condition

    6 months

  • Range of motion

    6 months

  • Shoulder muscle strength

    6 months

  • Oxford Shoulder Score (OSS)

    6 months

  • +5 more secondary outcomes

Study Arms (1)

ARCR-BursaSeries

EXPERIMENTAL

Tendon healing in the reconstruction of the rotator cuff, taking advantage of augmentation potential of the subacromial bursa.

Procedure: Doppler ultrasonography after bursa augmentation

Interventions

Doppler ultrasonography after bursa augmentationPROCEDURE

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.

ARCR-BursaSeries

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Legal incompetence
  • Last subacromial cortisone infiltration ≤ 6 months
  • Systemic rheumatologic-inflammatory disease
  • Diabetes Mellitus
  • Smoker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schulthess Klinik

Zurich, Canton of Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Rotator Cuff InjuriesRuptureNeovascularization, Pathologic

Condition Hierarchy (Ancestors)

Wounds and InjuriesShoulder InjuriesTendon InjuriesMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Markus Scheibel, MD

    Schulthess Klinik

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Model Details: prospective observational case-series
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2019

First Posted

June 14, 2019

Study Start

October 1, 2019

Primary Completion

August 22, 2023

Study Completion

August 22, 2023

Last Updated

June 3, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)