Clinical trial NCT06644729: From Rotator Cuff Repair to Reverse Shoulder Arthroplasty - Clinical and Radiological Results
Official title: From Rotator Cuff Repair to Reverse Shoulder Arthroplasty - Clinical and Radiological Results
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rotator Cuff Tears
Rotator Cuff Tear Arthropathy
Rotator Cuff Injuries
Keywords: PROM
Rotator Cuff Repair
Rotator Cuff Tear
Cuff Arthropathy
Lead sponsor: Lovisenberg Diakonale Hospital
Sponsor class: OTHER
Collaborators: name: Sykehuset Telemark
name: South-Eastern Norway Regional Health Authority
First posted: 2024-10-16
Enrollment: 733
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is participants with a rotator cuff repair treated with arthroscopic rotator cuff repair 2010-2014 at Lovisenberg Diaconal Hospital.

Brief 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. 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.

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

Primary outcomes:
measure: Western Ontario Rotator Cuff Index, Norwegian Version
timeFrame: 10 Years after surgery
Secondary outcomes:
measure: Eurocol questionnaire EQ-5D-5L Norwegian version
timeFrame: 10 Years after surgery
measure: Subjective Shoulder Value
timeFrame: 10 Years after surgery
measure: Rotator cuff survival
timeFrame: 10 Years after surgery
measure: Cuff arthropathy
timeFrame: 10 years after surgery
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Lovisenberg Diacolan Hospital
Study officials:
affiliation: Lovisenberg Diaconal Hospital
name: Kjersti Kaul Jenssen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: