Rotator Cuff Tear or Rupture, Not Specified as TraumaticROTCUFFNCT03717571
Superior Glenohumeral Translation in Patients With Degenerative Rotator Cuff Tears
An observational study of Rotator Cuff Tear or Rupture, Not Specified as Traumatic, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Degenerative partial and complete rupture of the rotator cuff is a common injury among elder patients. However, the clinical manifestation varies largely with some patients having severe pain and limiting range of motion and others having no complaints. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Tear or Rupture, Not Specified as Traumatic
- What is being tested?
- Glenohumeral translation assessment
- How many people
- 21 participants
- Where
- 1 siteSwitzerland
- Study dates
- 4 Oct 2018to 30 Sep 2020
- Phase
- Observational
- 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 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * 10 patients with isolated complete supraspinatus muscle tear * 10 patients with complete supraspinatus muscle tear and either partial infraspinatus muscle tear or partial subscapularis muscle tear * 10 healthy control subjects
Who may be able to join
- 45 years ≤ age ≤ 65 years
- Degenerative complete supraspinatus muscle tear or complete supraspinatus muscle tear and either partial infraspinatus muscle tear or partial subscapularis muscle tear
- Unilateral rotator cuff tear
- 45 years ≤ age ≤ 65 years
Who cannot join
- Traumatic tendon ruptures
- Incomplete supraspinatus muscle tear
- Tears in more than two rotator cuff muscles
- Prior conservative treatment or surgery of the ipsilateral upper extremity
- Clinical history of the contralateral glenohumeral joint
- Range of motion < 90° in abduction and flexion
Show all 9Show fewer
- Neuromuscular disorders affecting upper limb movement
- Additional pathologies that influence the mobility of the shoulder joints
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
Official title: ROTCUFF - Measuring Load-induced Superior Glenohumeral Translation in Patients With Degenerative Rotator Cuff Tears and Asymptomatic Subjects: 3-dimensional Motion Analysis Versus Single Plane Fluoroscopy
Degenerative partial and complete rupture of the rotator cuff is a common injury among elder patients. However, the clinical manifestation varies largely with some patients having severe pain and limiting range of motion and others having no complaints. The basic functions of the rotator cuff are to facilitate shoulder motion and stabilization and centering of the glenohumeral joint. The objective of this study is to quantify the difference in superior glenohumeral translation in patients with degenerative rotator cuff tear compared to healthy control subjects and to determine the effect of isolated complete supraspinatus tear and combined complete supraspinatus and either partial infraspinatus or partial subscapularis tear.
Read the detailed description
The study will examine a cohort of 10 patients with isolated complete supraspinatus muscle tear and 10 patients with complete supraspinatus muscle tear and either partial infraspinatus muscle tear or partial subscapularis muscle tear, and a cohort of 10 age-matched healthy control persons. The participants will be recruited from the Clinic of Orthopaedics and Traumatology at the University Hospital Basel. Inclusion criteria: 45 years < age < 65 years; degenerative complete supraspinatus muscle tear or complete supraspinatus muscle tear and either partial infraspinatus muscle tear or partial subscapularis muscle tear; unilateral rotator cuff tear. Exclusion criteria: traumatic tendon ruptures; prior treatment of the ipsilateral upper extremity; clinical history of the contralateral glenohumeral joint; no complete supraspinatus muscle tear; tears in more than two rotator cuff muscles; neuromuscular disorders affecting upper limb movement; additional pathologies that influence the mobility of the shoulder joint; inability to provide informed consent.
Patients will complete the health questionnaire and reflective markers and electromyographic sensors will be placed on anatomical landmarks and shoulder muscles, respectively, before loaded and unloaded abduction and flexion arm movements will be performed. Centre of rotation of both shoulders will be calculated to determine glenohumeral translation. This parameter will be compared between patient groups and control subjects using linear mixed models with group membership and load as fixed factor and subject as random factor. The critical shoulder angle will be included as covariate into the model to detect a potential modulating role of this factor on glenohumeral translation.
- Being tested
- Glenohumeral translation assessment
- Medical subject headings
- Rotator Cuff Injuries, Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glenohumeral translation assessmentDiagnostic test
amount of glenohumeral translation under load
| Study group | Role | What they receive |
|---|---|---|
| Control group | age and sex matched healthy control persons Receives: Diagnostic Test: Glenohumeral translation assessment | |
| isolated tear | patients with isolated complete supraspinatus muscle tear Receives: Diagnostic Test: Glenohumeral translation assessment | |
| combined tear | patients with complete supraspinatus muscle tear and either partial infraspinatus muscle tear or partial subscapularis muscle tear Receives: Diagnostic Test: Glenohumeral translation assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glenohumeral translation
Amount of glenohumeral translation under load
Measured: Baseline
Secondary outcomes (6)
Disabilities of arm, shoulder and Hand (DASH)
assessed using the Quick DASH (0 - no problems, 100 - extreme problems)
Measured: Baseline
Shoulder function
assessed using the Constant Shoulder Score (0 - no problems, >30 extreme problems)
Measured: Baseline
Shoulder pain
assessed using a 15 cm visual analogue scale converted to 0 to 100 scale (0 - no pain; 100 - worst pain imaginable)
Measured: Baseline
Critical shoulder angle (CSA)
measured on frontal plane radiographs in neutral arm position available from the clinical consultation. The CSA is the angle between the line connecting the superior with the inferior border of the glenoid fossa and the line connecting the inferior border of the glenoid fossa with the most inferolateral point of the acromion
Measured: Baseline
Muscle activity
root mean square of the electromyography (EMG) signal during the arm movements calculated and normalised to the maximal obtained signal intensity
Measured: Baseline
Glenohumeral translation from fluoroscopy
the perpendicular distance of the centre of the glenohumeral joint and the x-axis of the scapula coordinate system will be measured. Glenohumeral translation will be defined as the difference in this distance between the abducted arm positions and the resting arm position
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start4 Oct 2018
- Primary completion22 Feb 2019
- Study completion30 Sep 2020
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.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annegret Mündermann, PhD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03717571
- Sponsor's protocol ID
- EKNZ 2018-01692
- Acronym
- ROTCUFF
- Status last verified
- Mar 2022
- First submitted
- 22 Oct 2018
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROTCUFF - Measuring Load-induced Superior Glenohumeral Translation in Patients With Degenerative Rotator Cuff Tears and Asymptomatic Subjects: 3-dimensional Motion Analysis Versus Single Plane Fluoroscopy
- ClinicalTrials.gov ID
- NCT03717571
- Acronym / sponsor ID
- ROTCUFF / EKNZ 2018-01692
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 4 Oct 2018 (actual)
- Primary completion
- 22 Feb 2019 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 24 Oct 2018 (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.
Degenerative partial and complete rupture of the rotator cuff is a common injury among elder patients. However, the clinical manifestation varies largely with some patients having severe pain and limiting range of motion and others having no complaints. The basic functions of the rotator cuff are to facilitate shoulder motion and stabilization and centering of the glenohumeral joint. The objective of this study is to quantify the difference in superior glenohumeral translation in patients with degenerative rotator cuff tear compared to healthy control subjects and to determine the effect of isolated complete supraspinatus tear and combined complete supraspinatus and either partial infraspinatus or partial subscapularis tear.
Detailed description
The study will examine a cohort of 10 patients with isolated complete supraspinatus muscle tear and 10 patients with complete supraspinatus muscle tear and either partial infraspinatus muscle tear or partial subscapularis muscle tear, and a cohort of 10 age-matched healthy control persons. The participants will be recruited from the Clinic of Orthopaedics and Traumatology at the University Hospital Basel. Inclusion criteria: 45 years < age < 65 years; degenerative complete supraspinatus muscle tear or complete supraspinatus muscle tear and either partial infraspinatus muscle tear or partial subscapularis muscle tear; unilateral rotator cuff tear. Exclusion criteria: traumatic tendon ruptures; prior treatment of the ipsilateral upper extremity; clinical history of the contralateral glenohumeral joint; no complete supraspinatus muscle tear; tears in more than two rotator cuff muscles; neuromuscular disorders affecting upper limb movement; additional pathologies that influence the mobility of the shoulder joint; inability to provide informed consent.
Patients will complete the health questionnaire and reflective markers and electromyographic sensors will be placed on anatomical landmarks and shoulder muscles, respectively, before loaded and unloaded abduction and flexion arm movements will be performed. Centre of rotation of both shoulders will be calculated to determine glenohumeral translation. This parameter will be compared between patient groups and control subjects using linear mixed models with group membership and load as fixed factor and subject as random factor. The critical shoulder angle will be included as covariate into the model to detect a potential modulating role of this factor on glenohumeral translation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Diagnostic Test: Glenohumeral translation assessmentage and sex matched healthy control persons |
| isolated tear | – | Diagnostic Test: Glenohumeral translation assessmentpatients with isolated complete supraspinatus muscle tear |
| combined tear | – | Diagnostic Test: Glenohumeral translation assessmentpatients with complete supraspinatus muscle tear and either partial infraspinatus muscle tear or partial subscapularis muscle tear |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * 10 patients with isolated complete supraspinatus muscle tear * 10 patients with complete supraspinatus muscle tear and either partial infraspinatus muscle tear or partial subscapularis muscle tear * 10 healthy control subjects
Key inclusion criteria (4 listed)
- 45 years ≤ age ≤ 65 years
- Degenerative complete supraspinatus muscle tear or complete supraspinatus muscle tear and either partial infraspinatus muscle tear or partial subscapularis muscle tear
- Unilateral rotator cuff tear
- 45 years ≤ age ≤ 65 years
Key exclusion criteria (9 listed)
- Traumatic tendon ruptures
- Incomplete supraspinatus muscle tear
- Tears in more than two rotator cuff muscles
- Prior conservative treatment or surgery of the ipsilateral upper extremity
- Clinical history of the contralateral glenohumeral joint
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 |
|---|---|---|
| Glenohumeral translation assessmentamount of glenohumeral translation under load | Diagnostic test | Control group, combined tear, isolated tear |
Primary outcome
Glenohumeral translation
Time frame: Baseline
Amount of glenohumeral translation under load
6 secondary outcomes
Disabilities of arm, shoulder and Hand (DASH)
Time frame: Baseline
Shoulder function
Time frame: Baseline
Shoulder pain
Time frame: Baseline
Critical shoulder angle (CSA)
Time frame: Baseline
Muscle activity
Time frame: Baseline
Glenohumeral translation from fluoroscopy
Time frame: Baseline
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 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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.
Annegret Mündermann, PhD principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Tear or Rupture, Not Specified as Traumatic, run by University Hospital, Basel, Switzerland 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 4 inclusion and 9 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 Mar 2022. 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?
Glenohumeral translation (time frame: Baseline). 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 Mar 2022.