Rotator Cuff Tear or Rupture, Not Specified as TraumaticARCR-BursaNCT03986749
Bursa Augmentation in Arthroscopic Rotator Cuff Repair
A study testing Doppler ultrasonography after bursa augmentation in people with Rotator Cuff Tear or Rupture, Not Specified as Traumatic, run by Schulthess Klinik at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rotator Cuff Tear or Rupture, Not Specified as Traumatic
- What is being tested?
- Doppler ultrasonography after bursa augmentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2019to 22 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Legal incompetence
- Last subacromial cortisone infiltration ≤ 6 months
- Systemic rheumatologic-inflammatory disease
- Diabetes Mellitus
- Smoker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Doppler ultrasonography after bursa augmentation
- Keywords
- arthroscopic rotator cuff repair, bursa augmentation, neovascularization, Doppler ultrasonography
- Medical subject headings
- Rotator Cuff Injuries, Rupture, Neovascularization, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler ultrasonography after bursa augmentationProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| ARCR-BursaSeries | Experimental | Tendon healing in the reconstruction of the rotator cuff, taking advantage of augmentation potential of the subacromial bursa. Receives: Procedure: Doppler ultrasonography after bursa augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic ultrasound examination with grading of blood vessels
using the modified Ohberg Score
Measured: 3 months
Secondary outcomes (10)
Tendon integrity
intact / partially ruptured / ruptured
Measured: 6 months
Tendon condition
Thickness of the repaired tendons (mm)
Measured: 6 months
Range of motion
Elevation (flexion), abduction, external rotation by 0° abduction, external-internal rotation by 90° abduction
Measured: 6 months
Shoulder muscle strength
Shoulder strength in 90° Abduction (kg) measured using a spring balance
Measured: 6 months
Oxford Shoulder Score (OSS)
Patient-reported Oxford Shoulder Score from 0 (worse) to 48 (best)
Measured: 6 months
Subjective shoulder value (SSV)
Patient-reported Subjective shoulder value from 0 (worse) to 100% (best)
Measured: 6 months
Constant Murley score (CMS)
Constant Murley functional score from 0 (worse) to 100 (best)
Measured: 6 months
Level of satisfaction
Level of satisfaction using Number Rating Scale from 0 (not satisfied) to 10 (highly satisfied)
Measured: 6 months
EQ-5D utilities
Patient-reported Quality of life (EuroQol EQ-5D-5L) as Utility index from 0 (worse) to 1 (best health)
Measured: 6 months
Adverse events
Number of patients with adverse events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start1 Oct 2019
- Primary completion22 Aug 2023
- Study completion22 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff Tear or Rupture, Not Specified as TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- prospective observational case-series
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schulthess Klinik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Markus Scheibel, MD, Principal investigator, Schulthess Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03986749
- Sponsor's protocol ID
- OE-0116 (ARCR-BursaSeries)
- Acronym
- ARCR-Bursa
- Status last verified
- May 2024
- First submitted
- 5 Jun 2019
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Augmentation With Subacromial Bursa in Arthroscopic Rotator Cuff Repair - Postoperative Findings Using Doppler Ultrasonography
- ClinicalTrials.gov ID
- NCT03986749
- Acronym / sponsor ID
- ARCR-Bursa / OE-0116 (ARCR-BursaSeries)
- Keywords
- arthroscopic rotator cuff repair, bursa augmentation, neovascularization, Doppler ultrasonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Schulthess KlinikUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 22 Aug 2023 (actual)
- Study completion
- 22 Aug 2023 (actual)
- First posted
- 14 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective observational case-series
| Arm | Type | Receives |
|---|---|---|
| ARCR-BursaSeries | Experimental | Procedure: Doppler ultrasonography after bursa augmentationTendon healing in the reconstruction of the rotator cuff, taking advantage of augmentation potential of the subacromial bursa. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- Legal incompetence
- Last subacromial cortisone infiltration ≤ 6 months
- Systemic rheumatologic-inflammatory disease
- Diabetes Mellitus
- Smoker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doppler ultrasonography after bursa augmentationDynamic 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. | Procedure or surgery | ARCR-BursaSeries |
Primary outcome
Dynamic ultrasound examination with grading of blood vessels
Time frame: 3 months
using the modified Ohberg Score
10 secondary outcomes
Tendon integrity
Time frame: 6 months
Tendon condition
Time frame: 6 months
Range of motion
Time frame: 6 months
Shoulder muscle strength
Time frame: 6 months
Oxford Shoulder Score (OSS)
Time frame: 6 months
Subjective shoulder value (SSV)
Time frame: 6 months
Constant Murley score (CMS)
Time frame: 6 months
Level of satisfaction
Time frame: 6 months
EQ-5D utilities
Time frame: 6 months
Adverse events
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Scheibel, MD principal investigator
Schulthess Klinik
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doppler ultrasonography after bursa augmentation in people with Rotator Cuff Tear or Rupture, Not Specified as Traumatic, run by Schulthess Klinik at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic ultrasound examination with grading of blood vessels (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2024.