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| Name | Class |
|---|---|
| Sykehuset Telemark | OTHER_GOV |
| South-Eastern Norway Regional Health Authority | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arthroscopic Rotator Cuff Repair | Procedure | Arthroscopic Rotator Cuff Repair |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 Years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The study population is participants with a rotator cuff repair treated with arthroscopic rotator cuff repair 2010-2014 at Lovisenberg Diaconal Hospital.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Birthe Marie Roang-Winjum, MD | Contact | 0047 90665939 | birroa@sthf.no | |
| Kjersti Kaul Jenssen, MD, PhD | Contact | 0047 91392624 | kjerstikaul.jenssen@lds.no |
| Name | Affiliation | Role |
|---|---|---|
| Kjersti Kaul Jenssen, MD, PhD | Lovisenberg Diaconal Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lovisenberg Diacolan Hospital | Recruiting | Oslo | 0456 | Norway |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 9, 2024 | Oct 14, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| D000070656 | Rotator Cuff Tear Arthropathy |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| 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%. | 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 | 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). | 10 years after surgery |
| D002805 |
| Chondrocalcinosis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |