From Rotator Cuff Repair to Reverse Shoulder Arthroplasty - Clinical and Radiological Results
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Arthroscopic Rotator Cuff Repair.
- Who it may be relevant to
- Registry conditions: Rotator Cuff Tears, Rotator Cuff Tear Arthropathy, Rotator Cuff Injuries. Basic parameters: 18 years — 95 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Procedure Arthroscopic Rotator Cuff Repair
Arthroscopic Rotator Cuff Repair
Primary outcome measures
- Western Ontario Rotator Cuff Index, Norwegian Version [Time frame: 10 Years after surgery]
Secondary outcome measures (4)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Norway · 1 center
- Lovisenberg Diacolan Hospital — Oslo
Identifiers
NCT: NCT06644729 · CARS3