From Rotator Cuff Repair to Reverse Shoulder Arthroplasty - Clinical and Radiological Results
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-95
SponsorLovisenberg Diakonale Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 population
The study population is participants with a rotator cuff repair treated with arthroscopic rotator cuff repair 2010-2014 at Lovisenberg Diaconal Hospital.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Arthroscopic Rotator Cuff Repair
Procedure/SurgeryArthroscopic Rotator Cuff Repair
Treatment groups
733 Participants
are divided into 1 treatment groupGroup A: Cohort 10 years after surgery1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
10 Years after surgerySecondary outcomes
1
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
Time frame
10 Years after surgery2
Subjective Shoulder Value
A patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%.
Time frame
10 Years after surgery3
Rotator cuff survival
Survival of rotator cuff repair in terms of number of reverse shoulder arthroplasties performed in the study group
Time frame
10 Years after surgery4
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).
Time frame
10 years after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Lovisenberg Diakonale Hospital
Lead sponsor
Sykehuset Telemark
Collaborator
South-Eastern Norway Regional Health Authority
Collaborator
Source ClinicalTrials.gov