Rotator Cuff TearsNCT06644729
From Rotator Cuff Repair to Reverse Shoulder Arthroplasty - Clinical and Radiological Results
An observational study of Rotator Cuff Tears and Rotator Cuff Tear Arthropathy, run by Lovisenberg Diakonale Hospital at 1 site in Norway.
Trial summary
In the planned study the investigators will invite 733 participants 10 years after arthroscopic rotator cuff repair to a follow up examination. Shoulder pain is a common problem in the Norwegian population. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Rotator Cuff Tears, Rotator Cuff Tear Arthropathy, Rotator Cuff Injuries
- What is being tested?
- Arthroscopic Rotator Cuff Repair
- Type of treatment
- Surgery or procedure
- How many people
- 733 participants
- Where
- 1 siteNorway
- Study dates
- 11 Sep 2024to Dec 2025
- How long will I take part?
- 10 Years
- 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 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population is participants with a rotator cuff repair treated with arthroscopic rotator cuff repair 2010-2014 at Lovisenberg Diaconal Hospital.
Who may be able to join
- Operated at Lovisenberg Diaconal Hospital in the time period 2010-2014 with an arthroscopic rotator cuff repair
- Included in the rotator cuff registry at Lovisenberg Diaconal Hospital
- Able to read and write Norwegian
Who cannot join
- Lack of competence to consent
- Not able to submit patient reported outcome measurements in any way and not able to undergo x-ray
- Patient is unwilling to participate
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Lovisenberg Diacolan Hospital
Oslo, 0456
Birthe Roang-Winjum, MD, +47 90665939, birroa@sthf.no
Kjersti Jenssen, MD, PhD, +47 91392624, kjerstikaul.jenssen@lds.no
About this study
In the planned study the investigators will invite 733 participants 10 years after arthroscopic rotator cuff repair to a follow up examination.
Shoulder pain is a common problem in the Norwegian population. Rotator cuff tear is a major cause of shoulder pain with a reported prevalence of up to 51% in patients 60-80 years of age. Arthroscopic rotator cuff repair is performed in an increasing proportion of these patients. Good results in shoulder function has been reported, although there is a lack in published good quality studies and long term follow up of these patients. There is also a lack of evidence regarding the association between radiologically-verified re-tear and clinical outcome.
In this project, the investigators address these critical gaps in knowledge and aim to investigate the factors influencing the clinical outcome after rotator cuff surgery and re-tear in a large prospective cohort study. The investigators will investigate how many participants suffering from poor outcome and develop cuff arthropathy in need of reverse shoulder arthroplasty after 10 years.
Read the detailed description
10 years after surgery: A cohort study of 733 participants with rotator cuff tear operated arthroscopically at Lovisenberg Diaconal Hospital during 2010-2014. The investigators will ask the participants included at the time of surgery to participate in a ten-year follow-up. The investigators will ask them to submit validated patient reported outcome measurements (PROMs): Western Ontario Rotator Cuff Index, EQ-5D-5L, Subjective Shoulder Value. The investigators will also evaluate the radiological result and signs of cuff arthropathy on x-ray according to Hamada-Fukuda and Seebauer classification.
The main objective is to quantify the relative importance of preoperative and perioperative prognostic factors on functional outcomes ten years after rotator cuff repair. The secondary objective is to identify and quantify patients who need shoulder replacement surgery ten years after rotator cuff surgery as a measure of failure.
- Being tested
- Arthroscopic Rotator Cuff Repair
- Keywords
- PROM, Rotator Cuff Repair, Rotator Cuff Tear, Cuff Arthropathy
- Medical subject headings
- Rotator Cuff Injuries, Rotator Cuff Tear Arthropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic Rotator Cuff RepairProcedure or surgery
Arthroscopic Rotator Cuff Repair
| Study group | Role | What they receive |
|---|---|---|
| Cohort 10 years after surgery | Cohort of 733 participants will be invited to a 10 year follow up and will be evaluated with patient reported outcome measurements and x-ray. Receives: Procedure: Arthroscopic Rotator Cuff Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario Rotator Cuff Index, Norwegian Version
Scale 0-2100. The maximum score is 2100 (higher score means worse outcome). Zero (0) represents no symptoms at all.
Measured: 10 Years after surgery
Secondary outcomes (4)
Eurocol questionnaire EQ-5D-5L Norwegian version
Standardized generic questionnaire measuring health in five dimensions. 5 health dimensions described above includes 5 response categories of no problem, slight problems, moderate problems, severe problems, and extreme problems. The 5 responses give a health state or profile represented by a 5-digit number (for example, 12231) corresponding to response categories reported by patients for successive dimensions
Measured: 10 Years after surgery
Subjective Shoulder Value
A patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%.
Measured: 10 Years after surgery
Rotator cuff survival
Survival of rotator cuff repair in terms of number of reverse shoulder arthroplasties performed in the study group
Measured: 10 Years after surgery
Cuff arthropathy
Developement of cuff arthropathy on x-ray by Hamada-Fukuda and Seebauer classification. X-ray will be conducted in one Y-view (scapular view), three anterioposterior view (with arm in neutral, 30 degrees of internal rotation and 60 degrees of external rotation).
Measured: 10 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start11 Sep 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 733 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Lovisenberg Diakonale Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sykehuset Telemark, South-Eastern Norway Regional Health Authority
- Responsible party
- Principal investigator, Kjersti Kaul Jenssen, Lovisenberg Diakonale Hospital
- Investigators
- Kjersti Kaul Jenssen, MD, PhD, Principal investigator, Lovisenberg Diaconal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06644729
- Sponsor's protocol ID
- CARS3
- Status last verified
- Oct 2024
- First submitted
- 10 Sep 2024
- Last updated
- 22 Oct 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 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Rotator Cuff Repair to Reverse Shoulder Arthroplasty - Clinical and Radiological Results
- ClinicalTrials.gov ID
- NCT06644729
- Acronym / sponsor ID
- CARS3
- Keywords
- PROM, Rotator Cuff Repair, Rotator Cuff Tear, Cuff Arthropathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 733 participants (estimated)
- Lead sponsor
- Lovisenberg Diakonale HospitalUniversity, hospital or other
- Collaborators
- Sykehuset Telemark, South-Eastern Norway Regional Health Authority
- Study start
- 11 Sep 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 16 Oct 2024 (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.
In the planned study the investigators will invite 733 participants 10 years after arthroscopic rotator cuff repair to a follow up examination.
Shoulder pain is a common problem in the Norwegian population. Rotator cuff tear is a major cause of shoulder pain with a reported prevalence of up to 51% in patients 60-80 years of age. Arthroscopic rotator cuff repair is performed in an increasing proportion of these patients. Good results in shoulder function has been reported, although there is a lack in published good quality studies and long term follow up of these patients. There is also a lack of evidence regarding the association between radiologically-verified re-tear and clinical outcome.
In this project, the investigators address these critical gaps in knowledge and aim to investigate the factors influencing the clinical outcome after rotator cuff surgery and re-tear in a large prospective cohort study. The investigators will investigate how many participants suffering from poor outcome and develop cuff arthropathy in need of reverse shoulder arthroplasty after 10 years.
Detailed description
10 years after surgery: A cohort study of 733 participants with rotator cuff tear operated arthroscopically at Lovisenberg Diaconal Hospital during 2010-2014. The investigators will ask the participants included at the time of surgery to participate in a ten-year follow-up. The investigators will ask them to submit validated patient reported outcome measurements (PROMs): Western Ontario Rotator Cuff Index, EQ-5D-5L, Subjective Shoulder Value. The investigators will also evaluate the radiological result and signs of cuff arthropathy on x-ray according to Hamada-Fukuda and Seebauer classification.
The main objective is to quantify the relative importance of preoperative and perioperative prognostic factors on functional outcomes ten years after rotator cuff repair. The secondary objective is to identify and quantify patients who need shoulder replacement surgery ten years after rotator cuff surgery as a measure of failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 10 years after surgery | – | Procedure: Arthroscopic Rotator Cuff RepairCohort of 733 participants will be invited to a 10 year follow up and will be evaluated with patient reported outcome measurements and x-ray. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is participants with a rotator cuff repair treated with arthroscopic rotator cuff repair 2010-2014 at Lovisenberg Diaconal Hospital.
Key inclusion criteria (3 listed)
- Operated at Lovisenberg Diaconal Hospital in the time period 2010-2014 with an arthroscopic rotator cuff repair
- Included in the rotator cuff registry at Lovisenberg Diaconal Hospital
- Able to read and write Norwegian
Key exclusion criteria (3 listed)
- Lack of competence to consent
- Not able to submit patient reported outcome measurements in any way and not able to undergo x-ray
- Patient is unwilling to participate
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 |
|---|---|---|
| Arthroscopic Rotator Cuff RepairArthroscopic Rotator Cuff Repair | Procedure or surgery | Cohort 10 years after surgery |
Primary outcome
Western Ontario Rotator Cuff Index, Norwegian Version
Time frame: 10 Years after surgery
Scale 0-2100. The maximum score is 2100 (higher score means worse outcome). Zero (0) represents no symptoms at all.
4 secondary outcomes
Eurocol questionnaire EQ-5D-5L Norwegian version
Time frame: 10 Years after surgery
Subjective Shoulder Value
Time frame: 10 Years after surgery
Rotator cuff survival
Time frame: 10 Years after surgery
Cuff arthropathy
Time frame: 10 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 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.
Kjersti Kaul Jenssen, MD, PhD principal investigator
Lovisenberg Diaconal Hospital
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 Tears and Rotator Cuff Tear Arthropathy, run by Lovisenberg Diakonale Hospital at 1 site in Norway.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 22 Oct 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 Norway. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Birthe Marie Roang-Winjum, MD (0047 90665939, birroa@sthf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario Rotator Cuff Index, Norwegian Version (time frame: 10 Years after surgery). 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 22 Oct 2024.