Bursa Augmentation in Arthroscopic Rotator Cuff Repair (ARCR-Bursa)
Primary Purpose
Rotator Cuff Tear or Rupture, Not Specified as Traumatic
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Doppler ultrasonography after bursa augmentation
Sponsored by
About this trial
This is an interventional diagnostic trial for Rotator Cuff Tear or Rupture, Not Specified as Traumatic focused on measuring arthroscopic rotator cuff repair, bursa augmentation, neovascularization, Doppler ultrasonography
Eligibility 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
Sites / Locations
- Schulthess KlinikRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ARCR-BursaSeries
Arm Description
Tendon healing in the reconstruction of the rotator cuff, taking advantage of augmentation potential of the subacromial bursa.
Outcomes
Primary Outcome Measures
Dynamic ultrasound examination with grading of blood vessels
using the modified Ohberg Score
Secondary Outcome Measures
Tendon integrity
intact / partially ruptured / ruptured
Tendon condition
Thickness of the repaired tendons (mm)
Range of motion
Elevation (flexion), abduction, external rotation by 0° abduction, external-internal rotation by 90° abduction
Shoulder muscle strength
Shoulder strength in 90° Abduction (kg) measured using a spring balance
Oxford Shoulder Score (OSS)
Patient-reported Oxford Shoulder Score from 0 (worse) to 48 (best)
Subjective shoulder value (SSV)
Patient-reported Subjective shoulder value from 0 (worse) to 100% (best)
Constant Murley score (CMS)
Constant Murley functional score from 0 (worse) to 100 (best)
Level of satisfaction
Level of satisfaction using Number Rating Scale from 0 (not satisfied) to 10 (highly satisfied)
EQ-5D utilities
Patient-reported Quality of life (EuroQol EQ-5D-5L) as Utility index from 0 (worse) to 1 (best health)
Adverse events
Number of patients with adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03986749
Brief Title
Bursa Augmentation in Arthroscopic Rotator Cuff Repair
Acronym
ARCR-Bursa
Official Title
Biological Augmentation With Subacromial Bursa in Arthroscopic Rotator Cuff Repair - Postoperative Findings Using Doppler Ultrasonography
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Schulthess Klinik
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear or Rupture, Not Specified as Traumatic
Keywords
arthroscopic rotator cuff repair, bursa augmentation, neovascularization, Doppler ultrasonography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
prospective observational case-series
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ARCR-BursaSeries
Arm Type
Experimental
Arm Description
Tendon healing in the reconstruction of the rotator cuff, taking advantage of augmentation potential of the subacromial bursa.
Intervention Type
Procedure
Intervention Name(s)
Doppler ultrasonography after bursa augmentation
Intervention Description
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 Measure Information:
Title
Dynamic ultrasound examination with grading of blood vessels
Description
using the modified Ohberg Score
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Tendon integrity
Description
intact / partially ruptured / ruptured
Time Frame
6 months
Title
Tendon condition
Description
Thickness of the repaired tendons (mm)
Time Frame
6 months
Title
Range of motion
Description
Elevation (flexion), abduction, external rotation by 0° abduction, external-internal rotation by 90° abduction
Time Frame
6 months
Title
Shoulder muscle strength
Description
Shoulder strength in 90° Abduction (kg) measured using a spring balance
Time Frame
6 months
Title
Oxford Shoulder Score (OSS)
Description
Patient-reported Oxford Shoulder Score from 0 (worse) to 48 (best)
Time Frame
6 months
Title
Subjective shoulder value (SSV)
Description
Patient-reported Subjective shoulder value from 0 (worse) to 100% (best)
Time Frame
6 months
Title
Constant Murley score (CMS)
Description
Constant Murley functional score from 0 (worse) to 100 (best)
Time Frame
6 months
Title
Level of satisfaction
Description
Level of satisfaction using Number Rating Scale from 0 (not satisfied) to 10 (highly satisfied)
Time Frame
6 months
Title
EQ-5D utilities
Description
Patient-reported Quality of life (EuroQol EQ-5D-5L) as Utility index from 0 (worse) to 1 (best health)
Time Frame
6 months
Title
Adverse events
Description
Number of patients with adverse events
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurent Audigé, PhD
Phone
+41 44 385 7580
Email
laurent.audige@kws.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Scheibel, MD
Organizational Affiliation
Schulthess Klinik
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schulthess Klinik
City
Zürich
State/Province
ZH
ZIP/Postal Code
8008
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Markus Scheibel, MD
Phone
+41443857468
Email
markus.scheibel@kws.ch
First Name & Middle Initial & Last Name & Degree
Laurent Auduigé, PhD
Phone
+41443857580
Email
laurent.audige@kws.ch
12. IPD Sharing Statement
Plan to Share IPD
No
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Bursa Augmentation in Arthroscopic Rotator Cuff Repair
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